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

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
In HomeBehavioral ActivationParticipants 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-PersonBehavioral ActivationParticipants 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
NameTimeMethod
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
NameTimeMethod
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 Events3 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

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