N/A
N=121
A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT01599585 ↗Enrolled (actual)
121
Serious AEs
3.3%
Results posted
Jun 2017
Primary outcome: Primary: Beck Hopelessness Scale (BHS) — 4.888889; 4.428571 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Center for Telehealth and Technology
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Hopelessness Scale (BHS) |
5.214286; 5.527778 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Beck Depression Inventory -II (BDI-II) |
14.7619; 15 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Adverse Events |
6; 2 | — |
| SECONDARY Beck Depression Inventory -II (BDI-II) |
14.7619; 15 | — |
| SECONDARY Beck Depression Inventory -II (BDI-II) |
14.7619; 15 | — |
| SECONDARY Beck Depression Inventory -II (BDI-II) |
14.7619; 15 | — |
| SECONDARY Beck Hopelessness Scale (BHS) |
5.214286; 5.527778 | — |
| SECONDARY Beck Hopelessness Scale (BHS) |
5.214286; 5.527778 | — |
| SECONDARY Beck Hopelessness Scale (BHS) |
5.214286; 5.527778 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01599585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.