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

NCT ID: NCT01357577

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2017-10-31

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.

Detailed Description

A randomized clinical trial to evaluate the effectiveness of a relatively simple, manual-guided cognitive behavioral therapy (CBT) for PTSD in patients with substance use disorders (SUDs). One hundred sixty outpatients with comorbid PTSD and SUDs from three VA facilities will be randomly assigned to receive either CBT for PTSD in conjunction with standard treatment as usual (TAU) (n = 80) or TAU only (n = 80).

Conditions

PTSD; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1: TAU + CBT

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

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for PTSD

Intervention Type: 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 2: TAU

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive behavioral therapy for PTSD

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica L Hamblen, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States

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

White River Junction, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SPLA-01-S09

Identifier Type: -

Identifier Source: org_study_id