Positive Processes and Transition to Health (PATH)
Recruiting · NCT06093906 · Interventional (participants receive a specific treatment) · Lead sponsor: Case Western Reserve University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, the investigators will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.
Who can take part
Inclusion criteria
- 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 criteria
- 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).
Where it is running
3 locations listed across 3 US states.
- University of Delaware - Newark, Delaware, United States
- Case Western Reserve University - Cleveland, Ohio, United States
- University of Washington - Seattle, Washington, United States