Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-03-31

Brief Summary

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This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.

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Detailed Description

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This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD. CC helps clients explore the past as a step in their recovery process. It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings. It has particular relevance for VA in that many veterans suffer from PTSD and SUD. The new model demonstrated positive results in two pilot studies.

Conditions

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Posttraumatic Stress Disorder Substance Use Disorder Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Seeking Safety (SS)

17 sessions of present-focused therapy Seeking Safety

Group Type ACTIVE_COMPARATOR

Seeking Safety (SS)

Intervention Type BEHAVIORAL

Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD. It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders. In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.

Creating Change (CC)

17 sessions of past-focused Creating Change

Group Type EXPERIMENTAL

Creating Change (CC)

Intervention Type BEHAVIORAL

Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD. It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format. The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.

Interventions

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Creating Change (CC)

Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD. It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format. The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.

Intervention Type BEHAVIORAL

Seeking Safety (SS)

Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD. It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders. In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder
* Have used a substance in the 60 days prior to intake
* Outpatient
* Plan to stay in Boston for the next 6 months
* If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
* Have a stable mailing address and live nearby enough to come to VA Boston for treatment
* Able to sign informed consent
* Willing to participate in all assessments and urine testing
* Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns

Exclusion Criteria

* Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
* Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
* Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
* Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
* The patient is mandated to treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No