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Reducing Depression in Dementia Caregivers

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ClinicalTrials.gov Identifier: NCT00056316
Recruitment Status : Completed
First Posted : March 11, 2003
Results First Posted : November 19, 2008
Last Update Posted : June 23, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Missouri, St. Louis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Behavioral: Basic Education
Behavioral: Behavioral Skills Training: Experimental
Enrollment 74

Recruitment Details Recruitment took place from 10/2001 to 3/2004. Project information was distributed to Alzheimers Association Chapters and Area Agencies on Aging (AAA's) in Midwestern USA (IO, IL,IN, KS, MI, MO, MN, NB,WI).
Pre-assignment Details All enrolled participants who completed consent procedures were randomly assigned to groups.
Arm/Group Title Behavioral Skills Training Basic Education
Hide Arm/Group Description Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions. Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Period Title: Overall Study
Started 33 41 [1]
Completed 30 38
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             2             2
Death/NH placement of pt             1             1
[1]
over-enrolled due to potential higher rates of drop-out.
Arm/Group Title Behavioral Skills Training Basic Education Total
Hide Arm/Group Description Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions. Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. Total of all reporting groups
Overall Number of Baseline Participants 33 41 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 41 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  69.7%
26
  63.4%
49
  66.2%
>=65 years
10
  30.3%
15
  36.6%
25
  33.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 41 participants 74 participants
58.4  (11.9) 62.9  (9.6) 61.1  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 41 participants 74 participants
Female
33
 100.0%
41
 100.0%
74
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 41 participants 74 participants
33 41 74
1.Primary Outcome
Title Beck Depression Inventory II (Beck, Steer & Brown, 1996)
Hide Description 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
Time Frame Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Behavioral Skills Training Basic Education
Hide Arm/Group Description:
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Overall Number of Participants Analyzed 33 41
Mean (Standard Deviation)
Unit of Measure: Points on a scale
14.27  (8.07) 16.93  (8.46)
2.Primary Outcome
Title Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)
Hide Description 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
Time Frame Post-intervention, assessed 4-14 days after final intervention session.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.
Arm/Group Title Behavioral Skills Training Basic Education
Hide Arm/Group Description:
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Overall Number of Participants Analyzed 33 41
Mean (Standard Deviation)
Unit of Measure: Points on a scale
10.25  (7.23) 13.83  (8.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavioral Skills Training, Basic Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.93
Estimation Comments Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control
3.Secondary Outcome
Title Negative Affect Schedule (Watson, Clark & Tellegen, 1988)
Hide Description 10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.
Time Frame Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.
Arm/Group Title Behavioral Skills Training Basic Education
Hide Arm/Group Description:
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Overall Number of Participants Analyzed 33 41
Mean (Standard Deviation)
Unit of Measure: Points on a scale
24.15  (6.72) 24.17  (7.25)
4.Secondary Outcome
Title Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)
Hide Description 10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.
Time Frame Post-intervention, assessed 4-14 days after final intervention session.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.
Arm/Group Title Behavioral Skills Training Basic Education
Hide Arm/Group Description:
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Overall Number of Participants Analyzed 33 41
Mean (Standard Deviation)
Unit of Measure: Points on a scale
18.52  (5.66) 21.63  (6.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavioral Skills Training, Basic Education
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.07
Estimation Comments Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Skills Training Basic Education
Hide Arm/Group Description Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions. Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
All-Cause Mortality
Behavioral Skills Training Basic Education
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Behavioral Skills Training Basic Education
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Behavioral Skills Training Basic Education
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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: Ann M. Steffen, PhD, Associate Professor
Organization: University of Missouri-St. Louis
Phone: 314-516-5382
Publications:
Steffen AM. Anger management for dementia caregivers: A preliminary study using video and telephone interventions. Behavior Therapy 31:281-299, 2000.
Responsible Party: Ann M. Steffen, Ph.D./Associate Professor of Psychology, University of Missouri-St. Louis
ClinicalTrials.gov Identifier: NCT00056316     History of Changes
Other Study ID Numbers: R21MH061956 ( U.S. NIH Grant/Contract )
R21MH061956 ( U.S. NIH Grant/Contract )
DSIR AT-GS
First Submitted: March 10, 2003
First Posted: March 11, 2003
Results First Submitted: October 23, 2008
Results First Posted: November 19, 2008
Last Update Posted: June 23, 2014