Integrated Cognitive Behavioral Therapy (ICBT) for Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders

NCT01457404 | Completed Phase 3 DMC

• 1 other identifier: 5R01DA030102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and practicality, feasibility and efficacy of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans population, as delivered by routine clinicians at the Veterans Affairs.

Conditions

Stress Disorder, Post-Traumatic; Substance-Related Disorders

Keywords

integrated cognitive behavioral therapy; cognitive behavioral therapy; addiction; posttraumatic stress disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

• Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months

  Baseline, post-treatment, 3 months post treatment

Secondary Outcomes (1)

• Reduction from baseline in substance use severity (Addiction Severity Index [ASI]) at 3-months and at 6-months

  Baseline, post treatment, 3 months post treatment

Study Arms (2)

Integrated Cognitive Behavioral Therapy

EXPERIMENTAL

Integrated Cognitive Behavioral Therapy (ICBT) is a non-exposure based, manual-guided individual or group therapy. ICBT consists of 3 learning and skill components designed to improve PTSD symptoms and substance use: 1) Patient education about PTSD and its relation to substance use and treatment; 2) Mindful relaxation: A behavioral anxiety reduction skill including centering and breathing techniques; and 3) Cognitive restructuring/flexible thinking: A cognitive approach and functional analysis of the link among emotions, cognitives and situations.

Behavioral: Integrated Cognitive Behavioral Therapy

Treatment-as-usual

ACTIVE COMPARATOR

Treatment-as-usual (TAU) is the typical outpatient treatment that patients would receive ordinarily at the PVAMC Substance Abuse Treatment Program (SATP) or PTSD Clinic.

Behavioral: Treatment-as-usual

Interventions

Integrated Cognitive Behavioral Therapy BEHAVIORAL

Individual or group ICBT, approx. 12 sessions, one session per week

Also known as: ICBT, CBT for PTSD, CBT

Integrated Cognitive Behavioral Therapy

Treatment-as-usual BEHAVIORAL

Individual or group therapy as usual within the SATP or PTSD clinics at the PVAMC

Also known as: TAU

Treatment-as-usual

Eligibility Criteria

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

You may qualify if:

• OEF/OIF/OND Veteran status;
• Diagnosis of PTSD confirmed by the Clinician Administered PTSD Scale (CAPS) with a total symptom score of 44 or more;
• Diagnosis of a substance use disorder (abuse or dependence) and confirmed by the Structured Clinical Interview of DSM-IV Section E (SCID-E);
• Willing and able to provide informed consent;

You may not qualify if:

• Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if their symptoms are stable and they are well connected with appropriate mental health services);
• Psychiatric hospitalization or suicide attempt in the past month (however, if the hospitalization or attempt was directly related substance intoxication or detoxification and ther person is currently stable, they are eligible);
• Medical or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Brown University: collaborator
• Providence VA Medical Center: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Providence Veterans Affairs Medical Center (PVAMC)

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark P. McGovern, Ph.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and of Community and Family Medicine

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 24, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

US (1)