ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Behavioral Activation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of In-Home Tele-behavioral Health Care Utilizing Behavioral Activation for Depression
Study Start Date : May 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: In Home
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: 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.
Other Name: BA

Active Comparator: In-Person
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: 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.
Other Name: BA




Primary Outcome Measures :
  1. Beck Hopelessness Scale (BHS) [ Time Frame: Post treatment - Week 8 ]
    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.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Treatment Session Week 1 ]
    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.

  2. Beck Depression Inventory -II (BDI-II) [ Time Frame: Baseline ]
    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.

  3. Adverse Events [ Time Frame: Treatment Session Week 2 ]
    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.

  4. Adverse Events [ Time Frame: Treatment Session Week 3 ]
    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.

  5. Adverse Events [ Time Frame: Treatment Session Week 4 ]
    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.

  6. Adverse Events [ Time Frame: Treatment Session Week 5 ]
    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.

  7. Adverse Events [ Time Frame: Treatment Session Week 6 ]
    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.

  8. Adverse Events [ Time Frame: Treatment Session Week 7 ]
    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.

  9. Adverse Events [ Time Frame: Treatment Session Week 8 ]
    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.

  10. Adverse Events [ Time Frame: 3 month follow up ]
    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.

  11. Beck Depression Inventory -II (BDI-II) [ Time Frame: Midpoint- Week 4 ]
    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

  12. Beck Depression Inventory -II (BDI-II) [ Time Frame: Post Treatment- Week 8 ]
    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.

  13. Beck Depression Inventory -II (BDI-II) [ Time Frame: 3 month follow up ]
    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.

  14. Beck Hopelessness Scale (BHS) [ Time Frame: Baseline ]
    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.

  15. Beck Hopelessness Scale (BHS) [ Time Frame: Midpoint- Week 4 ]
    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.

  16. Beck Hopelessness Scale (BHS) [ Time Frame: 3 month follow up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current Major Depressive or Minor Depressive Disorder
  • High-speed internet/network access at home (384kbs minimum)
  • Informed consent
  • Fluent in the English language

Exclusion Criteria:

  • Currently undergoing psychotherapy for depression
  • less than 18 or greater than 65 year of age
  • Active psychotic symptoms/disorders as determined by the SCID for DSM-IV
  • Dysthymic Disorder
  • Current suicidal ideation with intent or recent (within six months) history of a suicide attempt
  • History of Organic Mental Disorder
  • Current substance dependence as determined by the SCID (lifetime substance dependence or substance abuse will not be excluded)
  • History of violence or poor impulse control causing potential risk to staff or others
  • Significant ongoing stressors that require urgent crisis intervention
  • Having a living arrangement that will not permit the use of a private space to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599585


Locations
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97207
United States, Washington
National Center for Telehealth and Technology
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
National Center for Telehealth and Technology
VA Office of Research and Development
Investigators
Principal Investigator: Gregory A Gahm, PhD National Center for Telehealth and Technology
Principal Investigator: David D Luxton, PhD National Center for Telehealth & Technology

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: May 16, 2012    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Center for Telehealth and Technology:
Depression
Behavioral Activation
Tele-medicine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders