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Integrated vs Sequential Treatment for PTSD and Addiction

Primary Purpose

PTSD, Substance Addiction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prolonged Exposure

Motivational Enhancement Therapy

About this trial

This is an interventional treatment trial for PTSD focused on measuring Treatment, PTSD, Addiction

Eligibility Criteria

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

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.

Sites / Locations

VA Medical Center, Minneapolis
Philadelphia VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1: Integrated Conditions

Arm 2 Sequential therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PTSD Symptoms

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01211106

First Posted

September 27, 2010

Last Updated

January 17, 2017

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01211106

Brief Title

Integrated vs Sequential Treatment for PTSD and Addiction

Official Title

Integrated vs Sequential Treatment for PTSD and Addiction Among OEF/OIF Veterans

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

PTSD, Substance Addiction

Keywords

Treatment, PTSD, Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

183 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Integrated Conditions

Arm Type

Experimental

Arm Description

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 Title

Arm 2 Sequential therapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Prolonged Exposure

Intervention Description

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

Intervention Name(s)

Motivational Enhancement Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

PTSD Symptoms

Description

Time Frame

16 weeks

Title

Drinking Outcome

Description

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.

Time Frame

16 weeks

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David W. Oslin, MD

Organizational Affiliation

Philadelphia VA Medical Center, Philadelphia, PA

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Medical Center, Minneapolis

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417

Country

United States

Facility Name

Philadelphia VA Medical Center, Philadelphia, PA

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34881912

Citation

Scott JC, Lynch KG, Cenkner DP, Kehle-Forbes SM, Polusny MA, Gur RC, Chen S, Foa EB, Oslin DW. Neurocognitive predictors of treatment outcomes in psychotherapy for comorbid PTSD and substance use disorders. J Consult Clin Psychol. 2021 Nov;89(11):937-946. doi: 10.1037/ccp0000693.

Results Reference

derived

PubMed Identifier

27444425

Citation

Kehle-Forbes SM, Drapkin ML, Foa EB, Koffel E, Lynch KG, Polusny MA, Van Horn DH, Yusko DA, Charlesworth M, Blasco M, Oslin DW. Study design, interventions, and baseline characteristics for the Substance use and TRauma Intervention for VEterans (STRIVE) trial. Contemp Clin Trials. 2016 Sep;50:45-53. doi: 10.1016/j.cct.2016.07.017. Epub 2016 Jul 19.

Results Reference

derived

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Integrated vs Sequential Treatment for PTSD and Addiction

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