Integrated vs Sequential Treatment for PTSD and Addiction

NCT01211106 | Completed Results DMC

• 1 other identifier: ZDA1-03-W10
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

PTSD; Substance Addiction

Keywords

Treatment; PTSD; Addiction

Outcome Measures

Primary Outcomes (2)

• 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.

  16 weeks

• 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.

  16 weeks

Study Arms (2)

Arm 1: Integrated Conditions

EXPERIMENTAL

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.

Behavioral: Prolonged Exposure; Behavioral: Motivational Enhancement Therapy

Arm 2 Sequential therapy

EXPERIMENTAL

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.

Behavioral: Prolonged Exposure; Behavioral: Motivational Enhancement Therapy

Interventions

Prolonged Exposure 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.

Arm 1: Integrated Conditions; Arm 2 Sequential therapy

Motivational Enhancement Therapy 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 1: Integrated Conditions; Arm 2 Sequential therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Provides informed consent
• Speaks and reads English

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Alpert E, Kaplan A, Nelson D, Oslin DW, Polusny MA, Ingram EP, Kehle-Forbes SM. Clusters Based on Within-Treatment Symptom Trajectories as Predictors of Dropout in Treatment for Posttraumatic Stress Disorder and Substance Use Disorder. J Dual Diagn. 2024 Jun 6:1-21. doi: 10.1080/15504263.2024.2355953. Online ahead of print.

  PMID: 38843038 DERIVED

• 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.

  PMID: 34881912 DERIVED

• 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.

  PMID: 27444425 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Behavior, Addictive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Both arms of the study were active treatments. There was no control conditions.

Results Point of Contact

• Title: David Oslin, MD
• Organization: Cpl Micheal J Crescenz VA Medical Center

dave.oslin@va.gov

215-823-5894

Study Officials

• David W. Oslin, MD

  Philadelphia VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 29, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)