N/A
N=81
Behavioral Activation for PTSD/Depression Treatment in OIF/OEF Veterans
Posttraumatic Stress Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00805532 ↗Enrolled (actual)
81
Serious AEs
11.3%
Results posted
Nov 2018
Primary outcome: Primary: Clinician Administered PTSD Scale (CAPS-IV) — 75.9; 82.0; 54.4; 70.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation treatment (Behavioral); Treatment as Usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale (CAPS-IV) |
75.9; 82.0; 54.4; 70.1; 56.25; 64.6 | — |
| SECONDARY Posttraumatic Stress Disorder Checklist-Military Version (PCL-M) |
59.0; 59.0; 44.1; 52.6; 48.0; 51.4 | — |
| SECONDARY Beck Depression Inventory-II (BDI-II) |
24.8; 25.2; 17.5; 23.3; 21.0; 21.5 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
19.0; 18.0; 15.0; 16.0; 15.9; 16.1 | — |
| SECONDARY Behavioral Activation Scale (BAS) |
76.0; 74.2; 89.5; 82.0; 79.4; 83.8 | — |
Summary
The present study is a randomized, controlled trial that compares Behavioral Activation (BA) to Treatment As Usual (TAU) in PTSD Specialty clinics, as early psychotherapeutic interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD).
Eligibility Criteria
Inclusion Criteria
- Ability to comply with assessment and therapy schedule.
- Ability to comply with study regulations.
- English fluency.
- Must meet diagnostic criteria for PTSD (related to trauma experienced during military service). PTSD will be assessed using the Clinician-Administered PTSD Scale for DSM-IV (CAPS; Blake, Weathers, Nagy, Kaloupek, Charney & Keane, 2003).
Exclusion Criteria
- Bipolar disorder.
- Psychotic disorders.
- Substance dependence. Because these conditions warrant alternative treatments. Bipolar, psychotic and substance dependence disorders will be assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I; First, Spitzer, Gibbon & Williams, 2002).
- Report active and imminent suicidal intent. If imminent suicidality is present, this would suggest that a treatment specifically targeting this intent is indicated. Suicidal intent will be assessed using The Brief Assessment for Suicidal Ideation or Behavior that was designed for this study.
Data sourced from ClinicalTrials.gov (NCT00805532). 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.