Trial of Art Therapy During Cognitive Processing Therapy for PTSD

Study Overview
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Brief Summary
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This is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for PTSD.

Detailed Description
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The objective of this study is to examine the effects of art therapy with combat veterans who have PTSD and to measure if it reduces symptoms more than verbal Cognitive Processing Therapy (CPT) alone. This study will incorporate art processes and materials into an already established protocol of CPT in order to create a sense of safety for veterans in beginning therapy, and access the nonverbal parts of the trauma in order to process it. Art-making will be used to help veterans address trauma and integrate who they were before the trauma with who they are currently. It will assist in addressing the grief and loss caused by combat, and will be used as veterans begin building a worldview and self-concept that are not filled with trauma and war. It is hypothesized that the veterans who receive art therapy with CPT will show a significantly greater decrease in PTSD symptoms than those who receive only CPT.

Official Title
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Randomized, Controlled Trial of Art Therapy During Cognitive Processing Therapy for PTSD

Conditions
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Post-traumatic Stress Disorder, Stress Disorder, Post-Traumatic

Intervention / Treatment
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* Behavioral: Cognitive Processing therapy
* Behavioral: Art + CPT
* Behavioral: CPT + Art Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCL-M initial score >= 50; Both genders, All ethnicities, Veterans in treatment for PTSD, Exclusion Criteria: No active substance use disorder, No active suicidal or homicidal ideation, No psychosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Subjects will receive 8 sessions of Cognitive Processing Therapy. | Behavioral: Cognitive Processing therapy<br>* 8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson & Chard (11/2010)<br>* Other names: CPT;|
| Experimental: Experimental<br>Subjects will receive 8 sessions of CPT + Art Therapy 8 sessions of individual therapy. | Behavioral: Art + CPT<br>* 8 sessions of individual therapy of mixes techniques Art + CPT 8 sessions of standard CPT (same 8 as in control group) from manual developed by Dr.s Resick, Monson & Chard (11/2010)<br>|
| Experimental: Experimental 2<br>Subject to receive 8 sessions of individual therapy for Art + CPT Cognitive Processing Therapy intervention pre-specified to be administered separately. | Behavioral: CPT + Art Therapy<br>* Subjects to complete 8 sessions of standard Cognitive Processing Therapy from manual developed by Dr. S. Resick, Monson & Chard (1/2010) CPT + Art Therapy of mixed individual techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptoms assessed by PCL-M score | PTSD symptoms will be measured by PCL-M score | 8-12 weeks | 
| Depression Symptoms assessed by Beck Depression Inventory-II | Beck Depression Inventory-II will be used to measure depression | 8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Satisfaction assessed by Likert scale | Likert scale will be used to compare satisfaction with art and CPT conditions | 8-12 weeks | 
| Treatment completion assessed by dropout rate | Compare dropout rate between experimental and control groups during treatment | 8-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD