Integrated vs Sequential Treatment for PTSD and Addiction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators are examining different treatment strategies of helping patients with PTSD and addiction.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intervention for Veterans With Depression, Substance Disorder, and Trauma

NCT00958217

Depressive Symptoms Substance-related Disorders Posttraumatic Stress Disorders

COMPLETED NA

Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)

NCT01120067

Stress Disorders, Post-Traumatic

COMPLETED NA

An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

NCT02956434

Posttraumatic Neuroses

COMPLETED NA

Integrated Alcohol Disorder and PTSD Treatment

NCT01601067

PTSD Alcoholism

COMPLETED PHASE2

Exercise and PTSD in Older Veterans

NCT02295995

Post-traumatic

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators hypothesize that Veterans in the integrated conditions will show greater reductions in substance abuse and PTSD symptom severity at the end of treatment and at 6 and 9 month follow-ups. The investigators further hypothesize that offering Veterans Prolonged Exposure (PE) at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PTSD Substance Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Integrated Conditions

Motivational enhancement therapy for addiction is combined with Prolonged exposure therapy for PTSD from the beginning of treatment. Both are delivered by the same provider throughout treatment.

Group Type EXPERIMENTAL

Prolonged Exposure

Intervention Type BEHAVIORAL

Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.

Motivational Enhancement Therapy

Intervention Type BEHAVIORAL

Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.

Arm 2 Sequential therapy

Motivational enhancement therapy for addiction is delivered in the first 4 weeks and only after the addiction is addressed is the Prolonged exposure therapy for PTSD started.

Group Type EXPERIMENTAL

Prolonged Exposure

Intervention Type BEHAVIORAL

Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.

Motivational Enhancement Therapy

Intervention Type BEHAVIORAL

Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prolonged Exposure

Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.

Intervention Type BEHAVIORAL

Motivational Enhancement Therapy

Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female Persian Gulf Era veterans between 18-65 years old. Older individuals are unlikely to have served in Iraq or Afghanistan.
* Current diagnosis of PTSD (symptom duration \> 3 months) with clinically significant trauma-related symptoms, as indicated by a score of at least 50 on the PCL
* Current abuse or dependence on alcohol, stimulants such as cocaine, opioids, including prescription opioids or benzodiazepines. Subjects must report using on average at least 10 out of 30 days prior to signing consent. Of note: subjects can be abusing or dependent upon nicotine or marijuana but these will not be considered sufficient for inclusion
* Provides informed consent
* Speaks and reads English

Exclusion Criteria

* Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment
* Meets current DSM-IV criteria for bipolar affective disorder, schizophrenia or any psychotic disorder
* Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease
* History of moderate or severe traumatic brain injury (TBI)
* Participation in Prolonged Exposure Therapy in the last 6 months.
* Initiation of a new psychotherapy program in the last 2 months.
* Active participation in a formal addiction treatment program. Actively engaged is defined as any visit in the program in the prior month and pending future appointments for the treatment of addictions
* Change in psychotropic medication in the 1 month prior to treatment except for the use of oxazepam for alcohol detoxification or a taper of a previously used benzodiazepine.
* Therapeutic use of a benzodiazepine greater than the equivalent of more than 40 mg of diazepam (see chart) at the time of randomization.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No