Positive Processes and Transition to Health (PATH)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCase Western Reserve University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Positive Processes and Transition to Health
  • Progressive Muscle Relaxation

Treatment groups

135 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Case Western Reserve University

Lead sponsor

University of Washington

Collaborator

University of Delaware

Collaborator

National Institute of Mental Health (NIMH)

Collaborator