Integrated vs Sequential Treatment for PTSD and Addiction

Not Applicable

Completed

• Conditions: PTSD; Substance Addiction
• Interventions: Behavioral: Prolonged Exposure; Behavioral: Motivational Enhancement Therapy

• Registration Number: NCT01211106
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Study Start: 2011-02
• Primary Completion: 2016-03
• Study Completion: 2016-07
• Status Verified: 2017-01
• Results First Submitted: 2017-01-17
• Results First Submitted QC: 2017-01-17
• Last Update Submitted: 2017-01-17
• Results First Posted: 2017-03-09
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Integrated Conditions	Motivational Enhancement Therapy	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.
Arm 1: Integrated Conditions	Prolonged Exposure	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.
Arm 2 Sequential therapy	Prolonged Exposure	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.
Arm 2 Sequential therapy	Motivational Enhancement 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.

Primary Outcome Measures

Name	Time	Method
PTSD Symptoms	16 weeks	PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.
Drinking Outcome	16 weeks	Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.

Trial Locations

Locations (2)

VA Medical Center, Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States

Philadelphia VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States