Trial of Art Therapy During Cognitive Processing Therapy for PTSD (Art_Tx_PTSD)

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

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

Study Overview

• Status: Terminated
• Conditions: Post-traumatic Stress Disorder; Stress Disorder, Post-Traumatic
• Intervention / Treatment: Behavioral: Cognitive Processing therapy; Behavioral: Art + CPT; Behavioral: CPT + Art Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Hampton, Virginia, United States, 23667
      • Hampton VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Subjects will receive 8 sessions of Cognitive Processing Therapy.	Behavioral: Cognitive Processing therapy; 8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson & Chard (11/2010); Other Names: CPT
Experimental: Experimental; Subjects will receive 8 sessions of CPT + Art Therapy 8 sessions of individual therapy.	Behavioral: Art + CPT; 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)
Experimental: Experimental 2; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hampton VA Medical Center
• Investigators: Study Chair: Barbara Cross, Ph.D., FNP, IRB Chair

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): February 3, 2017
• Study Completion (Actual): February 13, 2017

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 13-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data (IPD) will not be made available to other researchers. Aggregated data and de-identified data could be potentially be shared at a future date.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No