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

Primary Purpose

Posttraumatic Stress Disorder, Substance Use Disorder, Alcohol Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Creating Change (CC)

Seeking Safety (SS)

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic stress disorder, Substance use disorder, Treatment efficacy, Randomized trial, Trauma, Substance abuse, Addiction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Boston Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Seeking Safety (SS)

Creating Change (CC)

Arm Description

17 sessions of present-focused therapy Seeking Safety

17 sessions of past-focused Creating Change

Outcomes

Primary Outcome Measures

Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup

PTSD symptoms assessed via self-report measure

Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup

PTSD diagnosis as assessed by a trained interviewer

Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup

Alcohol use and associated problems as measured by blinded-interviewer measure Composite. These outcome variables will be measured at baseline, end of treatment and 3-month followup.

Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup

Drug use and associated problems as measured by blinded-interviewer measure Composite. These outcome variables will be measured at baseline, end of treatment and 3-month followup. Urinanlysis/breathalyzer will be obtained to verify ASI self-report.

Secondary Outcome Measures

Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup

Self-report measure

Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup

Self-report measure

Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup

Self-report measure

Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure

Self-report measure

Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup

Self-report measure

Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup

Self-report measure

Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup

Self-report measure

Full Information

NCT ID

NCT01274741

First Posted

January 10, 2011

Last Updated

May 2, 2019

Sponsor

VA Boston Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT01274741

Brief Title

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

Official Title

Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

VA Boston Healthcare System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder, Substance Use Disorder, Alcohol Use Disorder

Keywords

Posttraumatic stress disorder, Substance use disorder, Treatment efficacy, Randomized trial, Trauma, Substance abuse, Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Seeking Safety (SS)

Arm Type

Active Comparator

Arm Description

17 sessions of present-focused therapy Seeking Safety

Arm Title

Creating Change (CC)

Arm Type

Experimental

Arm Description

17 sessions of past-focused Creating Change

Intervention Type

Behavioral

Intervention Name(s)

Creating Change (CC)

Intervention Description

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

Intervention Name(s)

Seeking Safety (SS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup

Description

PTSD symptoms assessed via self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup

Description

PTSD diagnosis as assessed by a trained interviewer

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup

Description

Alcohol use and associated problems as measured by blinded-interviewer measure Composite. These outcome variables will be measured at baseline, end of treatment and 3-month followup.

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup

Description

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Secondary Outcome Measure Information:

Title

Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup

Description

Self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup

Description

Self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup

Description

Self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure

Description

Self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup

Description

Self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup

Description

Self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

Title

Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup

Description

Self-report measure

Time Frame

Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen E. Krinsley, Ph.D.

Organizational Affiliation

VA Boston Healthcare System

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lisa M Najavits, PhD

Organizational Affiliation

VA Boston Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Boston Healthcare System

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02459

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29461920

Citation

Najavits LM, Krinsley K, Waring ME, Gallagher MW, Skidmore C. A Randomized Controlled Trial for Veterans with PTSD and Substance Use Disorder: Creating Change versus Seeking Safety. Subst Use Misuse. 2018 Sep 19;53(11):1788-1800. doi: 10.1080/10826084.2018.1432653. Epub 2018 Feb 20.

Results Reference

result

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

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