Positive Processes and Transition to Health (PATH)

NCT06093906 | Recruiting

• 2 other identifiers: STUDY201915194R33MH118401-03
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Affective Updating Task

  Measure updating of affective information in working memory

  Change from baseline score at 6 weeks (immediately post treatment)

• Idiographic Behavioral Approach Task

  Use in vivo confrontation with feared or avoided stimuli measuring avoidance behavior

  Change from baseline score at 6 weeks (immediately post treatment)

• Probabilistic Reward Task

  Assesses reward responsivity

  Change from baseline score at 6 weeks (immediately post treatment)

Secondary Outcomes (3)

• Posttraumatic Cognitions Inventory

  Change from baseline score at 6 weeks (immediately post treatment)

• Behavioral Activation for Depression Scale

  Change from baseline score at 6 weeks (immediately post treatment)

• Snaith-Hamilton Pleasure Scale

  Change from baseline score at 6 weeks (immediately post treatment)

Study Arms (2)

Positive Processes and Transition to Health (PATH)

EXPERIMENTAL

PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.

Behavioral: Positive Processes and Transition to Health

Progressive Muscle Relaxation (PMR)

ACTIVE COMPARATOR

PMR will be adapted from Berstein, Borkoveck, and Hazlett- Stevens (2000). PMR will be conducted in six, 60-90 min individual weekly sessions with a study therapist. Muscle groups are tightened and then relaxed with the attention of the patient focused on the contrast between tension and relaxation. Through regular practice, the person becomes more aware of tension in the body and can induce relaxation as needed (Field, 2009). During the six sessions of training, patients will be encouraged to practice PMR and learn how to deliberately induce physical relaxation to reduce stress and mental tension. Sessions will move from relaxation of 16-muscle groups to 7 muscle groups, 4 muscle groups, and finally to relaxation by recall. Patients will be instructed to practice daily, if possible, but at least two or three times a week, and to integrate the practice into their daily life. They will be provided with audio recordings and homework reporting forms to assist their home PMR exercises.

Behavioral: Progressive Muscle Relaxation

Interventions

Positive Processes and Transition to Health BEHAVIORAL

See arm/group description for details regarding this intervention

Also known as: PATH

Positive Processes and Transition to Health (PATH)

Progressive Muscle Relaxation BEHAVIORAL

See arm/group description for details regarding this intervention

Also known as: PMR

Progressive Muscle Relaxation (PMR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Case Western Reserve University: lead
• University of Washington: collaborator
• University of Delaware: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of Delaware

Newark, Delaware, 19716, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Norah Feeny, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noni Shemenski, BA

CONTACT

216-368-0338; ptsdlab@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, PTSD Treatment and Research Program

Model Details: Participants are randomized to receive PATH therapy or PMR.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)