Trial of Art Therapy During Cognitive Processing Therapy for PTSD

NCT02610049 | Terminated

• 1 other identifier: 13-04
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-traumatic Stress Disorder; Stress Disorder, Post-Traumatic

Keywords

PTSD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Treatment Satisfaction assessed by Likert scale

  8-12 weeks

• Treatment completion assessed by dropout rate

  8-12 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

Subjects will receive 8 sessions of Cognitive Processing Therapy.

Behavioral: Cognitive Processing therapy

Experimental

EXPERIMENTAL

Subjects will receive 8 sessions of CPT + Art Therapy 8 sessions of individual therapy.

Behavioral: Art + CPT

Experimental 2

EXPERIMENTAL

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

Interventions

Cognitive Processing therapy BEHAVIORAL

8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson \& Chard (11/2010)

Also known as: CPT

Control

Art + CPT BEHAVIORAL

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

CPT + Art Therapy BEHAVIORAL

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

Experimental 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PCL-M initial score \>= 50;
• Both genders,
• All ethnicities,
• Veterans in treatment for PTSD,

You may not qualify if:

• No active substance use disorder,
• No active suicidal or homicidal ideation,
• No psychosis

Sponsors & Collaborators

• Hampton VA Medical Center: lead

Study Sites (1)

Hampton VA Medical Center

Hampton, Virginia, 23667, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole; Reproductive Techniques, Assisted; Art Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques; Sensory Art Therapies; Complementary Therapies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Barbara Cross, Ph.D., FNP

  IRB Chair

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2013
• Primary Completion: February 3, 2017
• Study Completion: February 13, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)