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

Primary Purpose

Chronic Posttraumatic Stress Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Psychotherapy plus Methylene Blue, USP

Psychotherapy plus Placebo

Delayed Psychotherapy

About this trial

This is an interventional treatment trial for Chronic Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
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).
Current diagnosis of alcohol or substance dependence within the 3 previous months.
Unwilling or unable to discontinue current trauma-focused psychotherapy or psychotropic medication (at least 1 month medication free).
Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
Unstable cardiovascular, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or hematological disorder or current seizure disorder.
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.
A history of hypersensitivity or allergy to MB.
Any condition possibly affecting drug absorption (e.g., gastrectomy).
Glucose-6-phosphate dehydrogenase deficiency.
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.

Sites / Locations

University of Pennsylvania
University of Texas
University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Psychotherapy plus Methylene Blue, USP

Psychotherapy Plus Placebo

Delayed Psychotherapy

Arm Description

Outcomes

Primary Outcome Measures

PTSD Symptom Severity-Interview (PSS-I)

PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)

Secondary Outcome Measures

Full Information

NCT ID

NCT01188694

First Posted

July 20, 2010

Last Updated

May 16, 2017

Sponsor

University of Washington

Collaborators

University of Texas, University of Pennsylvania, National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01188694

Brief Title

Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

Acronym

HELP

Official Title

Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

University of Texas, University of Pennsylvania, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Posttraumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psychotherapy plus Methylene Blue, USP

Arm Type

Experimental

Arm Title

Psychotherapy Plus Placebo

Arm Type

Placebo Comparator

Arm Title

Delayed Psychotherapy

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Psychotherapy plus Methylene Blue, USP

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Psychotherapy plus Placebo

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Delayed Psychotherapy

Intervention Description

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 Measure Information:

Title

PTSD Symptom Severity-Interview (PSS-I)

Description

PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)

Time Frame

Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event. Between the age of 18 and 65. Exclusion Criteria: Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV. 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). Current diagnosis of alcohol or substance dependence within the 3 previous months. Unwilling or unable to discontinue current trauma-focused psychotherapy or psychotropic medication (at least 1 month medication free). Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases). Unstable cardiovascular, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or hematological disorder or current seizure disorder. 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. A history of hypersensitivity or allergy to MB. Any condition possibly affecting drug absorption (e.g., gastrectomy). Glucose-6-phosphate dehydrogenase deficiency. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lori A Zoellner, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Texas

City

Austin

State/Province

Texas

ZIP/Postal Code

78712

Country

United States

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28686823

Citation

Zoellner LA, Telch M, Foa EB, Farach FJ, McLean CP, Gallop R, Bluett EJ, Cobb A, Gonzalez-Lima F. Enhancing Extinction Learning in Posttraumatic Stress Disorder With Brief Daily Imaginal Exposure and Methylene Blue: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e782-e789. doi: 10.4088/JCP.16m10936.

Results Reference

derived

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Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

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