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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02610049
Other study ID # 13-04
Secondary ID
Status Terminated
Phase N/A
First received November 17, 2015
Last updated August 8, 2017
Start date November 2013
Est. completion date February 13, 2017

Study information

Verified date August 2017
Source Hampton VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date February 13, 2017
Est. primary completion date February 3, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Cognitive Processing therapy
8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson & Chard (11/2010)
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)
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

Locations

Country Name City State
United States Hampton VA Medical Center Hampton Virginia

Sponsors (1)

Lead Sponsor Collaborator
Hampton VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD Symptoms assessed by PCL-M score PTSD symptoms will be measured by PCL-M score 8-12 weeks
Primary Depression Symptoms assessed by Beck Depression Inventory-II Beck Depression Inventory-II will be used to measure depression 8-12 weeks
Secondary Treatment Satisfaction assessed by Likert scale Likert scale will be used to compare satisfaction with art and CPT conditions 8-12 weeks
Secondary Treatment completion assessed by dropout rate Compare dropout rate between experimental and control groups during treatment 8-12 weeks
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