Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-04-01
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prolonged Exposure therapy for posttraumatic stress disorder
15 participants who meet study inclusion/exclusion criteria will be individually administered a full course of PE during 10, 60 minute-sessions, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment (post session 5), post-treatment, and a 1-month follow-up.
Prolonged Exposure
\- Participation will occur throughout 17 weeks over 15 separate visits during which 10, 60-minute sessions of PE will take place. Session 1 of PE will focus on psychoeducation. Session 2 of PE will involve a continuation of psychoeducation and rationale for exposure as well as the collaborative construction of the in vivo exposure hierarchy. After session 2, participants will begin homework where they are instructed to confront situations on their hierarchy. Starting in session 3 of PE, participants will begin imaginal exposures to their worst trauma memory. This involves the participant recounting and visualizing the trauma memory aloud with the clinician in the room for 30-40 minutes. The session will end with 15-20 minutes of processing the imaginal exposure. Participants will continue in-session imaginal exposures until the end of treatment. Throughout the treatment, participants will listen to a recording of their imaginal exposure and engage in in vivo exposures daily.
Interventions
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Prolonged Exposure
\- Participation will occur throughout 17 weeks over 15 separate visits during which 10, 60-minute sessions of PE will take place. Session 1 of PE will focus on psychoeducation. Session 2 of PE will involve a continuation of psychoeducation and rationale for exposure as well as the collaborative construction of the in vivo exposure hierarchy. After session 2, participants will begin homework where they are instructed to confront situations on their hierarchy. Starting in session 3 of PE, participants will begin imaginal exposures to their worst trauma memory. This involves the participant recounting and visualizing the trauma memory aloud with the clinician in the room for 30-40 minutes. The session will end with 15-20 minutes of processing the imaginal exposure. Participants will continue in-session imaginal exposures until the end of treatment. Throughout the treatment, participants will listen to a recording of their imaginal exposure and engage in in vivo exposures daily.
Eligibility Criteria
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Inclusion Criteria
2. Meeting diagnostic criteria for PTSD as defined by DSM-5 assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Psychiatric Disorders (DIAMOND), and
3. Interest in starting PE
Exclusion Criteria
2. Untreated Bipolar Disorder or a history of a manic/mixed episode within the last 6 months,
3. Severe traumatic brain injury,
4. Major neurological problems,
5. Current substance use disorder of moderate or greater severity assessed by the DIAMOND,
6. Active risk to self or others,
7. Current participation in therapy other than present-centered supportive therapy,
8. Previously received \> 2 sessions of Prolonged Exposure, and
9. Having no memory of their traumatic event.
10. For participants who are currently prescribed psychotropic medication, they will be eligible for the study provided medication use has been stable for 2 months prior to enrollment and remains stable throughout participation
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Amanda W. Baker, Ph.D.
Principal Investigator
Principal Investigators
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Amanda W Baker, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Vladimir Ivkovic, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Amanda Baker, PhD
Role: primary
References
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Other Identifiers
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2022P002988
Identifier Type: -
Identifier Source: org_study_id