N/A
N=45
Positive Processes and Transition to Health
Major Depressive Disorder · Post Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04678232 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Affective Updating Task (Pe et al., 2013; Pe, Raes, et al., 2013) — 0.54 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Processes and Transition to Health (PATH) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Affective Updating Task (Pe et al., 2013; Pe, Raes, et al., 2013) |
0.54 | — |
| PRIMARY Idiographic Behavioral Approach Task |
25.65 | — |
| PRIMARY Probabilistic Reward Task (Pizzagalli et al., 2005) |
-.03 | — |
| SECONDARY Posttraumatic Cognitions Inventory (Foa et al., 1999) |
102.05 | — |
| SECONDARY Behavioral Activation for Depression Scale (Kanter et al., 2006) |
106.5 | — |
| SECONDARY Snaith-Hamilton Pleasure Scale (Snaith et al., 1995) |
21.79 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04678232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.