Positive Processes and Transition to Health

NCT04678232 | Completed Results

• 2 other identifiers: R61MH1136465R61MH118401-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The R61 will be an open trial to determine if Positive Processes and Transition to Health (PATH) engages the proposed targets: unproductive processing, avoidance, and reward deficits in a sample of 45 adults 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, will examine whether patients perceive PATH as helpful and complete/adhere to treatment, and therapist fidelity. Patients will receive 6 sessions of PATH (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 4, 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

Major Depressive Disorder; Post Traumatic Stress Disorder

Keywords

transdiagnostic intervention; ptsd; posttraumatic stress disorder; mdd; major depressive disorder; adult; therapy; mental health; destabilizing life events; stressful life events

Outcome Measures

Primary Outcomes (3)

• Affective Updating Task (Pe et al., 2013; Pe, Raes, et al., 2013)

  The Affective Updating task (Pe et al., 2013; Pe, Raes, et al., 2013) measures updating of affective information in working memory. The task requires participants to continuously monitor and modify relevant affective information in working memory. Performance is inhibited by rumination. Forty-seven positive and 49 negative words are included. Under high levels of stress, deficits in affective updating predict more depressive symptoms over one year (Pe et al., 2016) and efficiency of reappraisal (Pe et al., 2013). Affective updating in contrast, predicts subjective well-being (Pe et al., 2013). The AUT is scored using the mean proportion of correct responses across 4 types of stimulus sets (positive-positive-positive words, negative-negative-negative, positive-negative-positive, negative-positive-negative). Scores for the AUT range from 0 to 1. Lower scores reflect greater deficits in affecting updating, while higher scores indicate greater abilities with affective updating.

  Score at 6 weeks (immediately post treatment)

• Idiographic Behavioral Approach Task

  The Idiographic Behavioral Approach Task (BAT; Mori \& Aermendariz, 2001; Haynes, 2001) will use in vivo confrontation with feared or avoided stimuli measuring avoidance behavior. Each BAT is unique to each participant (e.g., news/videos of similar events, pictures of loved one). A general list of idiographic stimuli will be developed with participants, who will then approach the stimuli. The task requires participants to rate their subjective units of distress (SUDs) on a scale of 0-100 (0 = no distress, 100 = extreme distress). The primary outcome measured is mean peak SUDs. The mean peak SUDs is calculated by averaging together all of the participant's reported SUDs measured at their highest level of distress. Higher scores indicate a higher average level of distress across all items, and lower scores indicate less distress on average across all items.

  Score at 6 weeks (immediately post treatment)

• Probabilistic Reward Task (Pizzagalli et al., 2005)

  The Probabilistic Reward Task (PRT) assesses reward responsivity (e.g., Der-Avakian et al. 2013; Pizzagalli et al., 2005, 2008, 2008). In each trial, participants choose which of 2 difficult-to-differentiate stimuli was presented. Stimuli are groups of bunnies or dogs (diameter: 25 mm; eyes: 7 mm). Unknown to them, correct identification of the "rich stimulus" is rewarded 3 times more frequently ("Correct! You won 20 cents"). Reward propensity is calculated by increase in response bias during the final block relative to the first. Degree of response bias toward the frequently reinforced alternative is a robust measure of reward sensitivity (Pizzagalli et al., 2005, 2008; Vrieze et al., 2013). The PRT is administered online through Inquisit Lab on Millisecond. PRT scores range between -.75 to .65 (-.75 = lower reward sensitivity, .65 = greater reward sensitivity).

  Score at 6 weeks (immediately post treatment)

Secondary Outcomes (3)

• Posttraumatic Cognitions Inventory (Foa et al., 1999)

  Score at 6 weeks (immediately post treatment)

• Behavioral Activation for Depression Scale (Kanter et al., 2006)

  Score at 6 weeks (immediately post treatment)

• Snaith-Hamilton Pleasure Scale (Snaith et al., 1995)

  Score at 6 weeks (immediately post treatment)

Study Arms (1)

receive PATH therapy

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 (PATH)

Interventions

Positive Processes and Transition to Health (PATH) BEHAVIORAL

See arm/group description for details regarding this intervention

Also known as: PATH

receive PATH therapy

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

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Norah Feeny, PhD
• Organization: Case Western Reserve University

ncf2@case.edu

(216) 368-2695

Study Officials

• Norah C Feeny, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will receive PATH therapy.

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 21, 2020
• Study Start: October 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 30, 2024
• Results First Posted: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)