Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation, exposure, mementos and writing assignments, domain of meaning and integration, farewell ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a waiting time of four months. Participants in the minimal attention control group receive monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al. (1999) Behavior Therapy 30: 597-605) for three weeks.

Official Title
-----------------
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

Conditions
-----------------
Chronic Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Brief Eclectic Psychotherapy for PTSD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clear memory of an index traumatic event (sufficient for constructing a scene to be used in exposure) that occurred no less than six months prior to entering the trial (Montgomery and Bech 2000) PTSD according to the DSM-IV, related to the index traumatic event, as measured with the CAPS: frequency ≥ 1 and intensity ≥ 2 for a symptom to be counted plus a minimum level of overall severity ≥ 50 Not receiving other psychotherapy for PTSD during the 16 weeks of active treatment; psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed If on psychoactive medication: on a stable medication regimen for a minimum of two months prior to entering the trial Aged between 18 and 70 years Sufficient proficiency in the German language to participate in BEP Consent to be randomized into the trial Exclusion Criteria: Current psychotic, bipolar, substance-related, or severe personality disorder Current severe depressive disorder Severe cognitive impairment or a history of organic mental disorder Evidence of PTSD or depression immediately prior to the index trauma Ongoing threat of traumatic exposure Prominent current suicidal or homicidal ideation Asylum seeking status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>16 sessions Brief Eclectic Psychotherapy | Behavioral: Brief Eclectic Psychotherapy for PTSD<br>* 16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD<br>* Other names: BEP;|
| Placebo Comparator: Control group<br>Minimal attention waitlist group | Behavioral: Brief Eclectic Psychotherapy for PTSD<br>* 16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD<br>* Other names: BEP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores |  | Last month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to work and use of health care facilities |  | Last months | 
| Comorbidity: Structured Clinical Interview for DSM-IV SCID I (First et al. 1996); Hospital Anxiety and Depression Scale HADS (Zigmond and Snaith 1983) |  | Last month | 
| Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000) |  | Last month | 
| Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999) |  | Last month | 
| Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996) |  | Since trauma | 
| EEG, event-related potentials: P300 |  | At assessment | 
| Post-therapy / post-waitlist comparison, follow-up at 6month post therapy |  | Last month |