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Trial record 13 of 5359 for:    "Depressive Disorder" [DISEASE] AND Behavioral

A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01599585
Recruitment Status : Completed
First Posted : May 16, 2012
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
National Center for Telehealth and Technology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Intervention Behavioral: Behavioral Activation
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title In Home In-Person
Hide Arm/Group Description

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Period Title: Overall Study
Started 62 59
Completed 40 42
Not Completed 22 17
Reason Not Completed
Withdrawal by Subject             16             9
Lost to Follow-up             3             5
randomized did not start treatment             3             3
Arm/Group Title In Home In-Person Total
Hide Arm/Group Description

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Total of all reporting groups
Overall Number of Baseline Participants 62 59 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
 100.0%
59
 100.0%
121
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 59 participants 121 participants
34.8  (12.4) 35.6  (11.8) 35.1  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
Female
10
  16.1%
12
  20.3%
22
  18.2%
Male
52
  83.9%
47
  79.7%
99
  81.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
Hispanic or Latino
3
   4.8%
7
  11.9%
10
   8.3%
Not Hispanic or Latino
56
  90.3%
52
  88.1%
108
  89.3%
Unknown or Not Reported
3
   4.8%
0
   0.0%
3
   2.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
American Indian or Alaska Native
1
   1.6%
0
   0.0%
1
   0.8%
Asian
3
   4.8%
1
   1.7%
4
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  12.9%
10
  16.9%
18
  14.9%
White
44
  71.0%
41
  69.5%
85
  70.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   9.7%
7
  11.9%
13
  10.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants 59 participants 121 participants
62 59 121
1.Primary Outcome
Title Beck Hopelessness Scale (BHS)
Hide Description The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame Post treatment - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 45 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.888889  (4.642796) 4.428571  (4.939353)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection In Home, In-Person
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments One tailed test at .05a = .05 margin was set at standardized difference of .50
Method of Estimation Estimation Parameter Regression, Beta
Estimated Value 0.40
Confidence Interval (2-Sided) 90%
.12 to .68
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
AE data reported in adverse events section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Beck Depression Inventory -II (BDI-II)
Hide Description The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 – 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 62 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
27.59678  (10.44652) 29.71186  (11.33054)
4.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
adverse event data reported in adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
adverse event data reported in adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: participants
62 59
6.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse Event data recorded in Adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 48 44
Measure Type: Number
Unit of Measure: participants
0 0
7.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
adverse events are reported in adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 48 44
Measure Type: Number
Unit of Measure: participants
0 0
8.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
adverse events are reported in the adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 48 44
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
adverse events are reported in adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 45 42
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame Treatment Session Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse event data recorded in adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 45 42
Measure Type: Number
Unit of Measure: participants
0 0
11.Secondary Outcome
Title Adverse Events
Hide Description Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse event data is recorded in adverse event section
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 42 36
Measure Type: Number
Unit of Measure: participants
6 2
12.Secondary Outcome
Title Beck Depression Inventory -II (BDI-II)
Hide Description The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome
Time Frame Midpoint- Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 47 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.40425  (11.77444) 20.20455  (13.09106)
13.Secondary Outcome
Title Beck Depression Inventory -II (BDI-II)
Hide Description The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame Post Treatment- Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 62 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.82222  (12.01947) 11.7381  (12.07509)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection In Home, In-Person
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments One tailed test at .05a = .05 margin was set at standardized difference of .50
Method of Estimation Estimation Parameter Regression, Beta
Estimated Value .47
Confidence Interval (2-Sided) 90%
.16 to .78
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Beck Depression Inventory -II (BDI-II)
Hide Description The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 42 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.7619  (12.88752) 15  (12.61065)
15.Secondary Outcome
Title Beck Hopelessness Scale (BHS)
Hide Description The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 62 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
9  (5.118273) 10.37288  (6.133285)
16.Secondary Outcome
Title Beck Hopelessness Scale (BHS)
Hide Description The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame Midpoint- Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 48 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.041667  (5.63786) 7.954545  (6.261564)
17.Secondary Outcome
Title Beck Hopelessness Scale (BHS)
Hide Description The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Time Frame 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Home In-Person
Hide Arm/Group Description:

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Overall Number of Participants Analyzed 42 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.214286  (5.101582) 5.527778  (5.973686)
Time Frame Adverse events were collected from time of consent to final outcome assessment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title In Home In-Person
Hide Arm/Group Description

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.

Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

All-Cause Mortality
In Home In-Person
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
In Home In-Person
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/62 (4.84%)      1/59 (1.69%)    
Cardiac disorders     
Severe chest pain *  0/62 (0.00%)  0 1/59 (1.69%)  1
Immune system disorders     
hospitalization for high fever and chills *  1/62 (1.61%)  1 0/59 (0.00%)  0
Psychiatric disorders     
exacerbation of baseline suicidality *  1/62 (1.61%)  1 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
exacerbation of asthma symptoms requiring hospitalization *  1/62 (1.61%)  1 0/59 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
In Home In-Person
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/62 (4.84%)      1/59 (1.69%)    
General disorders     
broken nose *  1/62 (1.61%)  1 0/59 (0.00%)  0
syncopial episode *  1/62 (1.61%)  1 0/59 (0.00%)  0
Musculoskeletal and connective tissue disorders     
tore tendons in foot *  1/62 (1.61%)  1 0/59 (0.00%)  0
broken finger *  0/62 (0.00%)  0 1/59 (1.69%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Larry D. Pruitt, PhD
Organization: National Center for Telehealth and Technology
Phone: 253-968-2946
Publications:
Lewinsohn, PM, Biglan, A, Zeiss, AS. Behavioral treatment of depression. The behavioral management of anxiety, depression and pain. (pp.91-46. New York; Bunner/Mazel
Lewinsohn, PM, Gotlib, IH. Behavioral theory and treatment of depression. In E.E. Beckham and W.R. Leber (Eds). Handbook of depression (pp.352-375) New York: Guildford, 1995
Jacobson, NS, Martell, CR and Dimidjian, S. Behavioral activation therapy for depression: Returning to contextual roots. Clinical Psychology: Science and Practice 8(3):255-270, 2002
First, MB, Spitzer RL, Gibbon, M and Williams, JBW. Structured Clinical Interview for DSM-IV Axis Disorders. Arlington, VA: American Psychiatric Press. 2002
Beck, AT, and Steer RA. Beck Hopelessness Manual. San Antonio, TX: The Psychological Corporation. 1988
deJong Giervelde, J and Van Tilburg, TG. A six-item scale for overall emotional and social loneliness: Confirmative tests on a new survey data. Research on Aging, 28, 582-598, 2006.
Mackenzie, CS, Knox, VJ, Gekoski, WL and Macaulay, HL. An adaption and extension of the Attitudes Toward Seeking Professional Psychological Help Scale. Journal of Applied Social Psychology, 34, 2410-2435, 2004.
Ajzen, I. From intentions to actions: A theory of planned behavior. In J. Khul and J. Beckman (Eds). Action-control: From cognition to behavior (pp. 11-39) Heidelberg, Springer. 1985
Cohen, J. Statistical power analysis for the behavioral sciences (2nd ed). Hillsdale, NJ, Lawrence Erlbaum Associates, 1988
Responsible Party: National Center for Telehealth and Technology
ClinicalTrials.gov Identifier: NCT01599585     History of Changes
Other Study ID Numbers: W81XWH-11-2-0118
W81XWH-11-2-0118 ( Other Grant/Funding Number: US Army Medical Research Acquisition Activity )
First Submitted: May 11, 2012
First Posted: May 16, 2012
Results First Submitted: December 12, 2016
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017