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Positive Processes and Transition to Health (PATH)

Treatment of Stress-Related Psychopathology: Targeting Maladaptive and Adaptive Event Processing

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares Positive Processes and Transition to Health (PATH) with muscle relaxation training. It is for adults who have lasting symptoms of depression or PTSD (post-traumatic stress disorder) after a major loss or threat. Participants receive 6 treatment sessions, with 2 extra sessions if they improve only partly.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 65 years old.
  • Had a major loss or threat at least 12 weeks ago, but within the past 5 years.
  • Have at least moderate problems in 2 of 3 areas: reliving or dwelling on the event, avoiding reminders, or having trouble feeling interest or pleasure.

Who can't join

  • Currently have schizophrenia, delusional disorder (strong false beliefs), or a mental disorder caused by a physical brain condition.
  • Currently have bipolar disorder, depression with loss of touch with reality, or depression needing immediate mental health care, such as suicide risk with intent and a plan.
  • Have seriously harmed yourself or attempted suicide in the past 3 months.
  • Cannot or will not stop current cognitive behavioral therapy, a type of talk therapy.
  • Have no clear memory of the event, or it happened before age 3.
  • Have had changes in your dose of mental health medicine in the past 3 months.
  • Are still in an intimate relationship with the person who assaulted you, if the event was an assault.
  • Currently have a substance use disorder, meaning problem use of alcohol or drugs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

DE

OH

WA