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Short-Term Exposure for PTSD (STEP)

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ClinicalTrials.gov Identifier: NCT02874898
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michele Bedard-Gilligan, University of Washington

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date March 28, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
  • Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) [ Time Frame: 12 Weeks ]
    The PSS-I assesses symptoms of PTSD as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in PTSD symptoms
  • Treatment drop-out [ Time Frame: 2 Weeks ]
    Defined as completion of less than 5 of 6 sessions of IE treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02874898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
  • Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16) [ Time Frame: baseline, 4 week, and 12 Weeks ]
    The QIDS-SR16 assesses symptoms of depression as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in depression symptoms.
  • Change in Marijuana Problems Scale (MPS) [ Time Frame: baseline, 4 week, and 12 Weeks ]
    The MPS is a self-report that assesses the impacts of marijuana on various areas of life, including motivation and productivity, social relationships, work and finances, self-esteem, memory impairment, legal problems, and physical health. The MPS is administered at baseline, 4 week and 12 week follow up to assess change in marijuana abuse.
  • Change in Marijuana Frequency and Quantity [ Time Frame: baseline, 4 week, and 12 Weeks ]
    The Marijuana Frequency and Quantity Scale assesses the frequency and quantity of marijuana use and is administered at baseline, 4 week and 12 week follow up to assess changes in marijuana use.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-Term Exposure for PTSD
Official Title  ICMJE Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD
Brief Summary This study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana use. This study will assess how individuals with PTSD with heavy or no marijuana use perform on a discriminative conditioning and extinction paradigm designed to measure fear extinction learning, and how they respond to a brief daily imaginal exposure treatment in regards to PTSD symptom reduction.
Detailed Description In this study, 36 patients with chronic PTSD and heavy marijuana use (heavy) and 36 patients with chronic PTSD and no marijuana use (no use) will be recruited to examine the effects of marijuana use on behavioral (emotional experiencing), physiological (skin conductance, acoustic startle) and biological (cortisol, blood pressure) responding on a well-established discriminative conditioning and extinction paradigm. To examine real world therapeutic implications, we will also examine how individuals with PTSD and heavy or no marijuana use differentially respond to a brief (6 session, 50 min) daily imaginal exposure (IE) treatment. Throughout treatment, we will monitor level of cannabis metabolites in urine samples of marijuana users to correlate effects to outcomes and preliminarily explore how varying levels of cannabis metabolites affect extinction processes. Independent evaluators will assess patients at baseline, 4 weeks, and 12 weeks following study entry.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Post-Traumatic Stress Disorder
  • Marijuana Abuse
Intervention  ICMJE Behavioral: Brief Imaginal Exposure
Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it
Study Arms  ICMJE
  • Active Comparator: Heavy marijuana use
    Heavy marijuana users with PTSD
    Intervention: Behavioral: Brief Imaginal Exposure
  • Active Comparator: No marijuana use
    Non-marijuana users with PTSD
    Intervention: Behavioral: Brief Imaginal Exposure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2016)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Current PTSD diagnosis based on DSM-5 criteria, with a minimum duration of 12 weeks since the traumatic event;
  2. Between the age of 18 and 65;
  3. Current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months
  4. Current diagnosis of a cannabis use disorder based on DSM-5 or no current diagnosis of a substance use disorder

Exclusion Criteria:

  1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
  2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
  3. Unwilling or unable to discontinue current trauma-focused psychotherapy
  4. Any previous experience with prolonged exposure (PE) treatment
  5. No clear trauma memory or trauma before age 3
  6. Unstable dose of psychotropic medications in the prior 3 months
  7. Ongoing intimate relationship with the perpetrator (in assault related PTSD cases).
  8. Current diagnosis of a substance use disorder according to DSM-5, other than marijuana in the last 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michele A Bedard-Gilligan, PhD 2066853617 uwstep@uw.edu
Contact: Heidi J Ojalehto, BS 2066853617 hjo22@u.washington.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02874898
Other Study ID Numbers  ICMJE 51623-EG
1R34DA040034-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michele Bedard-Gilligan, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Michele A Bedard-Gilligan, PhD University of Washington
PRS Account University of Washington
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP