Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD) (HELP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Texas
University of Pennsylvania
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01188694
First received: July 20, 2010
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety. There are several effective therapies for PTSD, but they are often time consuming. The investigators want to see if the investigators can shorten treatment time while keeping therapy effective by adding a medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To examine whether medication plus psychotherapy helps with depression, trauma-related cognitions, and functioning.


Condition Intervention Phase
Chronic Posttraumatic Stress Disorder
Drug: Psychotherapy plus Methylene Blue, USP
Behavioral: Psychotherapy plus Placebo
Behavioral: Delayed Psychotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • PTSD symptom severity [ Time Frame: Pre- and post-treatment, 1-month and 3-month follow-ups ] [ Designated as safety issue: No ]
    PTSD Symptom Scale - Interview Version


Secondary Outcome Measures:
  • Depression symptom severity [ Time Frame: Pre- and post-treatment, 1-month and 3-month follow-ups ] [ Designated as safety issue: No ]
    Quick Inventory of Depressive Symptomatology - Self-Report

  • Trauma-related cognitions [ Time Frame: Pre- and post-treatment, 1-month and 3-month follow-ups ] [ Designated as safety issue: No ]
    Post-Traumatic Cognitions Inventory - Self-Report

  • General physical and psychological health [ Time Frame: Pre- and post-treatment, 1-month and 3-month follow-ups ] [ Designated as safety issue: No ]
    Medical Outcomes Study Short Form 36, Version 2 - Self-report

  • Functioning in work, social/leisure activities, and family/home life [ Time Frame: Pre- and post-treatment, 1-month and 3-month follow-ups ] [ Designated as safety issue: No ]
    Sheehan Disability Scale - Self-report


Estimated Enrollment: 42
Study Start Date: September 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychotherapy plus Methylene Blue, USP Drug: Psychotherapy plus Methylene Blue, USP
This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
Placebo Comparator: Psychotherapy Plus Placebo Behavioral: Psychotherapy plus Placebo
This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
Delayed Psychotherapy Behavioral: Delayed Psychotherapy
Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).

Detailed Description:

The psychotherapy the investigators are offering in this study is a type of cognitive behavioral therapy called imaginal exposure. In imaginal exposure, the investigators encourage the client to approach the memory of the trauma by recounting the trauma story to the therapist and discussing his or her reactions to the memory.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
  2. Between the age of 18 and 65.

Exclusion Criteria:

  1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
  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. Current diagnosis of alcohol or substance dependence within the 3 previous months.
  4. Unwilling or unable to discontinue current trauma-focused psychotherapy or psychotropic medication (at least 1 month medication free).
  5. Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
  6. Unstable cardiovascular, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or hematological disorder or current seizure disorder.
  7. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of active treatment.
  8. A history of hypersensitivity or allergy to MB.
  9. Any condition possibly affecting drug absorption (e.g., gastrectomy).
  10. Glucose-6-phosphate dehydrogenase deficiency.
  11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the judgment of the Medical Directors, would make the participant inappropriate for entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188694

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas
Austin, Texas, United States, 78712
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
University of Texas
University of Pennsylvania
Investigators
Principal Investigator: Lori A Zoellner, PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01188694     History of Changes
Other Study ID Numbers: 37340-G, R34MH087375, 107654
Study First Received: July 20, 2010
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014