A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression
- Conditions
- Depression
- Interventions
- Behavioral: Behavioral Activation
- Registration Number
- NCT01599585
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Current Major Depressive or Minor Depressive Disorder
- High-speed internet/network access at home (384kbs minimum)
- Informed consent
- Fluent in the English language
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description In Home Behavioral Activation 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. In-Person Behavioral Activation 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.
- Primary Outcome Measures
Name Time Method Beck Hopelessness Scale (BHS) 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
Name Time Method Beck Depression Inventory -II (BDI-II) 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.
Beck Hopelessness Scale (BHS) 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.
Adverse Events 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.
Trial Locations
- Locations (2)
National Center for Telehealth and Technology
🇺🇸Tacoma, Washington, United States
Portland VA Medical Center
🇺🇸Portland, Oregon, United States