PATH: Positive Processes and Transition to Health

Sponsor
Case Western Reserve University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04678232
Collaborator
University of Washington (Other), University of Delaware (Other)
45
Enrollment
1
Arm
20.9
Anticipated Duration (Months)

Study Details

Study Description

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 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Positive Processes and Transition to Health (PATH)
N/A

Detailed Description

Evidence-based psychotherapies for posttraumatic stress disorder (PTSD) and depression consistently produce strong, clinically meaningful effects for many individuals. However, these interventions also have significant dropout rates, a large minority of individuals continue to have debilitating symptoms, and even those who respond may be vulnerable to relapse upon future stressors. More efficient and mechanistically precise interventions are needed. Consistent with the cross-cutting theme of studying the role of the environment in the NIMH Strategic Plan, the etiological role of exposure to destabilizing, stressful life events is common to both PTSD and depression. Not only do they share common distress-related triggers, symptoms, and maintaining processes, but they also commonly co-occur (upwards of 60%). Current PTSD and depression treatments typically focus on their respective disorders rather than on common processes that maintain psychopathology; and, importantly, they do not explicitly target positive adaptive processes associated with resilience. Decades of experimental studies, prospective studies, and psychotherapy trials have identified interconnected maladaptive and adaptive processes associated with persistent psychopathology after stressful, destabilizing events. These maladaptive processes include: 1) unproductive event processing; 2) avoidance; and 3) reward sensitivity and processing deficits. These processes prolong negative mood, interfere with adaptive coping and processing of emotional material, and increase sensitivity to future stressful life events. PATH (Positive Processes and Transition to Health) directly targets these maladaptive processes while also teaching parallel adaptive skills (constructive processing, approach, and positive emotion processing and reward seeking). Six, 90-min sessions target individuals who have experienced a destabilizing life event and have persistent stressor-related symptoms. PATH utilizes life event processing (revisiting, meaning making), focusing repeatedly on an identified destabilizing life event, positive life events, and future events as a framework to identify maladaptive processes and teach constructive processing skills. PATH has the potential to reduce dropout, improve treatment engagement and outcomes, identify potential treatment mechanisms, and ultimately reduce the costly human and economic burden of stressor-related psychopathology.

For the open trial's "Go" to be achieved and to proceed to the R33, two criteria must be met. The first is that at least 2 of the 3 primary targets must change via PATH. A moderate effect size (d = 0.60) was chosen to reflect evidence of clinically meaningful target engagement (see Gold et al., 2017), in line with NIMH guidelines for a preliminary signal of target engagement/efficacy in intervention trials. Second, at least one of the secondary measures must show a moderate effect (d = 0.50) from pre- to post-treatment. We included measures of each of the targets, as they are conceptualized as interrelated parts of a "stuck" system. For "Go" to an R01 after the R33, in addition to target engagement, primary outcomes of PTSD and depression must show clinically meaningful gains (e.g., Barth et al., 2016; Cusak et al., 2016).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive PATH therapy.All participants will receive PATH therapy.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Stress-Related Psychopathology: Targeting Maladaptive and Adaptive Event Processing
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: receive PATH therapy

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)
See arm/group description for details regarding this intervention
Other Names:
  • PATH
  • Outcome Measures

    Primary Outcome Measures

    1. Affective Updating Task (Pe et al., 2013; Pe, Raes, et al., 2013) [Change from baseline score at 6 weeks (immediately post treatment)]

      Measure updating of affective information in working memory

    2. Idiographic Behavioral Approach Task [Change from baseline score at 6 weeks (immediately post treatment)]

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

    3. Probabilistic Reward Task (Pizzagalli et al., 2005) [Change from baseline score at 6 weeks (immediately post treatment)]

      Assesses reward responsivity

    Secondary Outcome Measures

    1. Posttraumatic Cognitions Inventory (Foa et al., 1999) [Change from baseline score at 6 weeks (immediately post treatment)]

      Self-report of negative, overgeneralized stressor-related thoughts

    2. Behavioral Activation for Depression Scale (Kanter et al., 2006) [Change from baseline score at 6 weeks (immediately post treatment)]

      Self-report of approach and avoidance in cognitive and behavioral domains (not specific to depression)

    3. Snaith-Hamilton Pleasure Scale (Snaith et al., 1995) [Change from baseline score at 6 weeks (immediately post treatment)]

      Self-report measuring the capacity to experience pleasure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Case Western Reserve University
    • University of Washington
    • University of Delaware

    Investigators

    • Principal Investigator: Norah C Feeny, PhD, Case Western Reserve University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norah Feeny, Professor, Case Western Reserve University
    ClinicalTrials.gov Identifier:
    NCT04678232
    Other Study ID Numbers:
    • R61MH113646
    First Posted:
    Dec 21, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norah Feeny, Professor, Case Western Reserve University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021