Trial of Art Therapy During Cognitive Processing Therapy for PTSD (Art_Tx_PTSD)
Primary Purpose
Post-traumatic Stress Disorder, Stress Disorder, Post-Traumatic
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing therapy
Art + CPT
CPT + Art Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD
Eligibility Criteria
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
Sites / Locations
- Hampton VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Experimental
Experimental 2
Arm Description
Subjects will receive 8 sessions of Cognitive Processing Therapy.
Subjects will receive 8 sessions of CPT + Art Therapy 8 sessions of individual therapy.
Subject to receive 8 sessions of individual therapy for Art + CPT Cognitive Processing Therapy intervention pre-specified to be administered separately.
Outcomes
Primary Outcome Measures
PTSD Symptoms assessed by PCL-M score
PTSD symptoms will be measured by PCL-M score
Depression Symptoms assessed by Beck Depression Inventory-II
Beck Depression Inventory-II will be used to measure depression
Secondary Outcome Measures
Treatment Satisfaction assessed by Likert scale
Likert scale will be used to compare satisfaction with art and CPT conditions
Treatment completion assessed by dropout rate
Compare dropout rate between experimental and control groups during treatment
Full Information
NCT ID
NCT02610049
First Posted
November 17, 2015
Last Updated
August 8, 2017
Sponsor
Hampton VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02610049
Brief Title
Trial of Art Therapy During Cognitive Processing Therapy for PTSD
Acronym
Art_Tx_PTSD
Official Title
Randomized, Controlled Trial of Art Therapy During Cognitive Processing Therapy for PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Investigator has retired.
Study Start Date
November 2013 (Actual)
Primary Completion Date
February 3, 2017 (Actual)
Study Completion Date
February 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hampton VA Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for PTSD.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Stress Disorder, Post-Traumatic
Keywords
PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects will receive 8 sessions of Cognitive Processing Therapy.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects will receive 8 sessions of CPT + Art Therapy 8 sessions of individual therapy.
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
Subject to receive 8 sessions of individual therapy for Art + CPT Cognitive Processing Therapy intervention pre-specified to be administered separately.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing therapy
Other Intervention Name(s)
CPT
Intervention Description
8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson & Chard (11/2010)
Intervention Type
Behavioral
Intervention Name(s)
Art + CPT
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
CPT + Art Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
PTSD Symptoms assessed by PCL-M score
Description
PTSD symptoms will be measured by PCL-M score
Time Frame
8-12 weeks
Title
Depression Symptoms assessed by Beck Depression Inventory-II
Description
Beck Depression Inventory-II will be used to measure depression
Time Frame
8-12 weeks
Secondary Outcome Measure Information:
Title
Treatment Satisfaction assessed by Likert scale
Description
Likert scale will be used to compare satisfaction with art and CPT conditions
Time Frame
8-12 weeks
Title
Treatment completion assessed by dropout rate
Description
Compare dropout rate between experimental and control groups during treatment
Time Frame
8-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Cross, Ph.D., FNP
Organizational Affiliation
IRB Chair
Official's Role
Study Chair
Facility Information:
Facility Name
Hampton VA Medical Center
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23667
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Trial of Art Therapy During Cognitive Processing Therapy for PTSD
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