Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs

NCT01357577 | Completed Results DMC

• 1 other identifier: SPLA-01-S09
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 3

Brief Summary

With this research, the investigators hope to learn if cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with drugs or alcohol. In the past, people who had problems with drugs and alcohol were not given treatment for their PTSD. It was believed that PTSD treatment would get in the way of their drug and alcohol treatment. Now the investigators believe that the PTSD symptoms may make it harder to avoid using drugs and alcohol, so the investigators want to see if people can get treatment for both problems at the same time. One hundred-sixty Veterans from 3 sites who have both PTSD and substance use disorders will be in the study. In order to know if the PTSD treatment is helpful, half of the Veterans in this study will receive PTSD treatment and half will continue to get their usual mental health and/or substance abuse treatment. Who gets which treatment will be decided by a random process. The investigators will then compare the 2 groups to see if there are differences in their PTSD symptoms.

Conditions

PTSD; Substance Use Disorders

Keywords

PTSD; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment.

  PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS). The Clinician Administered PTSD SCALE (CAPS) is the gold standard in PTSD assessment. It is a structured interview that can be used to: Make current (past month) diagnosis of PTSD and Make lifetime diagnosis of PTSD. The minimum value is a 0 and the maximum is 135, the higher the score the worse the outcome, i.e. the more severe PTSD.

  Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up

Secondary Outcomes (4)

• Addiction Severity Index (Alcohol Addiction)

  Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months

• Addiction Severity Index (Drug Use)

  Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months

• PTSD Checklist (PCL)

  Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months

Study Arms (2)

Arm 1: TAU + CBT

EXPERIMENTAL

The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).

Behavioral: Cognitive behavioral therapy for PTSD

Arm 2: TAU

NO INTERVENTION

The "no intervention" group will receive treatment as usual (TAU).

Interventions

Cognitive behavioral therapy for PTSD BEHAVIORAL

The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.

Arm 1: TAU + CBT

Eligibility Criteria

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

You may qualify if:

• At least age 18.
• Current SUD diagnosis.
• Score of at least 45 on CAPS.
• Must speak English.
• Must agree to be taped.

You may not qualify if:

• Acute psychotic symptoms, if not well connected with appropriate mental health services.
• Severe suicidality.
• Individuals with unstable medical or legal situations that would make completion of the study highly unlikely.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Jessica L. Hamblen, PhD
• Organization: VA National Center for PTSD

jessica.hamblen@va.gov

8022965132

Study Officials

• Jessica L Hamblen, PhD

  White River Junction VA Medical Center, White River Junction, VT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: January 1, 2013
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)