Tests PATH therapy against muscle relaxation for PTSD or depression after a loss
Compares a behavioral program with muscle relaxation in adults with PTSD or depression.
Plain-language title generated from the registry record
Registry title: Positive Processes and Transition to Health (PATH)
Key facts
- Where
- Cleveland, Newark, and Seattle, United StatesSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06093906, who can take part
Where in United States
- Case Western Reserve UniversityCleveland, United StatesTaking people
- University of DelawareNewark, United StatesTaking people
- University of WashingtonSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Case Western Reserve University
- Trial code
- NCT06093906
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
Treatment of Stress-Related Psychopathology: Targeting Maladaptive and Adaptive Event Processing
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.
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: Severe self-injurious behavior or suicide attempt within the previous three months; Unstable dose of psychotropic medications in prior 3 months; 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); Current diagnosis of a substance use disorder (DSM-5); No clear memory of the destabilizing event or event occurred before age 3; Unwilling or unable to discontinue current cognitive behavioral psychotherapy; Ongoing intimate relationship with the perpetrator (in assault related event).