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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188694
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
University of Texas
University of Pennsylvania
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Lori Zoellner, University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Posttraumatic Stress Disorder Drug: Psychotherapy plus Methylene Blue, USP Behavioral: Psychotherapy plus Placebo Behavioral: Delayed Psychotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
Study Start Date : September 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. PTSD Symptom Severity-Interview (PSS-I) [ Time Frame: Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-) ]
    PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01188694

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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
National Institute of Mental Health (NIMH)
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Principal Investigator: Lori A Zoellner, PhD University of Washington

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lori Zoellner, Professor, Department of Psychology, University of Washington Identifier: NCT01188694    
Other Study ID Numbers: 37340
R34MH087375 ( U.S. NIH Grant/Contract )
107654 ( Other Identifier: FDA IND# )
First Posted: August 25, 2010    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action