Recruiting

Positive Processes and Transition to Health (PATH)

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ClinicalTrials.gov IDNCT06093906

PhaseNA

Enrollment135

SponsorCase Western Reserve University

Age18 Years – 65 Years

SexALL

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Conditions studied

Posttraumatic Stress Disorder, Major Depressive Disorder

About this study

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.

Interventions

Behavioral: Positive Processes and Transition to Health — See arm/group description for details regarding this intervention
Behavioral: Progressive Muscle Relaxation — See arm/group description for details regarding this intervention

Primary outcomes

Affective Updating Task (Change from baseline score at 6 weeks (immediately post treatment))
Idiographic Behavioral Approach Task (Change from baseline score at 6 weeks (immediately post treatment))
Probabilistic Reward Task (Change from baseline score at 6 weeks (immediately post treatment))

Eligibility information

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).

Study locations

University of Delaware, Newark, Delaware 19716 United States
Case Western Reserve University, Cleveland, Ohio 44106 United States
University of Washington, Seattle, Washington 98195 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-12.