Status:
COMPLETED
Positive Processes and Transition to Health
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
University of Washington
University of Delaware
Conditions:
Major Depressive Disorder
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The R61 will be an open trial to determine if Positive Processes and Transition to Health (PATH) engages the proposed targets: unproductive processing, avoidance, and reward deficits in a sample of 45...
Detailed Description
Evidence-based psychotherapies for posttraumatic stress disorder (PTSD) and depression consistently produce strong, clinically meaningful effects for many individuals. However, these interventions als...
Eligibility Criteria
Inclusion
- Destabilizing life event involving profound loss or threat, with a minimum duration of 12 weeks since the event, but occurred within the last 5 years.
- Between the ages of 18 and 65.
- Elevated target: Scores of at least moderate (1 or higher) on at least 2 of the 3 target mechanisms: re- experiencing or ruminative processing of the destabilizing event (PSS-I items: 1, 2, 3, 4 or QIDS-C item 11), avoidance (PSS-I items 6, 7, 8), or reward deficits (PSS-I items 12, 13, or QIDS-C item 13).
Exclusion
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5.
- 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).
- Severe self-injurious behavior or suicide attempt within the previous three months.
- Unwilling or unable to discontinue current cognitive behavioral psychotherapy.
- No clear memory of the destabilizing event or event occurred before age 3.
- Unstable dose of psychotropic medications in prior 3 months.
- Ongoing intimate relationship with the perpetrator (in assault related event).
- Current diagnosis of a substance use disorder (DSM-5).
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04678232
Start Date
October 1 2021
End Date
June 30 2023
Last Update
October 30 2024
Active Locations (3)
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1
University of Delaware
Newark, Delaware, United States, 19716
2
Case Western Reserve University
Cleveland, Ohio, United States, 44106
3
University of Washington
Seattle, Washington, United States, 98195