RECRUITING

Positive Processes and Transition to Health (PATH)

Conditions

Posttraumatic Stress Disorder Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-22

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06093906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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).

Inclusion Criteria

Exclusion 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).

* 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).

Contacts and Locations

Study Contact

Noni Shemenski, BA

CONTACT

216-368-0338

ptsdlab@case.edu

Principal Investigator

Norah Feeny, PhD

PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Case Western Reserve University

Norah Feeny, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-08-22

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder
Major Depressive Disorder