Integrated vs Sequential Treatment for PTSD and Addiction

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211106
• Other study ID #: ZDA1-03-W10
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: November 29, 2016
• Start date: February 2011
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• PTSD
• Substance Addiction
• Substance-Related Disorders

Intervention

Behavioral:
• Prolonged Exposure
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.
• Motivational Enhancement Therapy
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.

Locations

Country	Name	City	State
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	Philadelphia VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	substance use and PTSD symptoms		16 weeks	No