Chronic Posttraumatic Stress Disorder
Conditions
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.
Interventions
DRUGPsychotherapy 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.
BEHAVIORALPsychotherapy 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.
BEHAVIORALDelayed 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).
Sponsors
University of Texas
University of Pennsylvania
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptom Severity-Interview (PSS-I) | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psychotherapy Plus Methylene Blue, USP 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. | 15 |
| Psychotherapy Plus Placebo 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. | 16 |
| Delayed Psychotherapy 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). | 11 |
| Total | 42 |
Baseline characteristics
| Characteristic | Psychotherapy Plus Methylene Blue, USP | Psychotherapy Plus Placebo | Delayed Psychotherapy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 11 Participants | 42 Participants |
| Region of Enrollment United States | 15 participants | 16 participants | 11 participants | 42 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 8 Participants | 30 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 15 | 4 / 16 | 1 / 11 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 | 0 / 11 |
Outcome results
Primary
PTSD Symptom Severity-Interview (PSS-I)
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-)
Population: Intent to Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychotherapy Plus Methylene Blue, USP | PTSD Symptom Severity-Interview (PSS-I) | 1 Month Follow-up | 10.33 units on a scale | Standard Deviation 3.77 |
| Psychotherapy Plus Methylene Blue, USP | PTSD Symptom Severity-Interview (PSS-I) | Pre-Treatment | 32.07 units on a scale | Standard Deviation 6.17 |
| Psychotherapy Plus Methylene Blue, USP | PTSD Symptom Severity-Interview (PSS-I) | Post-Treatment | 17.10 units on a scale | Standard Deviation 10.57 |
| Psychotherapy Plus Methylene Blue, USP | PTSD Symptom Severity-Interview (PSS-I) | 3 Month Follow-up | 7.63 units on a scale | Standard Deviation 5.53 |
| Psychotherapy Plus Placebo | PTSD Symptom Severity-Interview (PSS-I) | Pre-Treatment | 31.38 units on a scale | Standard Deviation 6.88 |
| Psychotherapy Plus Placebo | PTSD Symptom Severity-Interview (PSS-I) | 3 Month Follow-up | 10.93 units on a scale | Standard Deviation 9.95 |
| Psychotherapy Plus Placebo | PTSD Symptom Severity-Interview (PSS-I) | 1 Month Follow-up | 13.33 units on a scale | Standard Deviation 9.15 |
| Psychotherapy Plus Placebo | PTSD Symptom Severity-Interview (PSS-I) | Post-Treatment | 14.67 units on a scale | Standard Deviation 9.27 |
| Delayed Psychotherapy | PTSD Symptom Severity-Interview (PSS-I) | 1 Month Follow-up | 28.33 units on a scale | Standard Deviation 7.43 |
| Delayed Psychotherapy | PTSD Symptom Severity-Interview (PSS-I) | 3 Month Follow-up | 7.25 units on a scale | Standard Deviation 9.82 |
| Delayed Psychotherapy | PTSD Symptom Severity-Interview (PSS-I) | Post-Treatment | 29.60 units on a scale | Standard Deviation 8.4 |
| Delayed Psychotherapy | PTSD Symptom Severity-Interview (PSS-I) | Pre-Treatment | 32.73 units on a scale | Standard Deviation 7.24 |