NCT04678232: PATH

Positive Processes and Transition to Health

Completed NA Results posted Last updated 30 October 2024

What this trial tests

NA trial testing Positive Processes and Transition to Health (PATH) in Major Depressive Disorder in 45 participants. Completed in 30 June 2023.

Timeline

1 October 2021

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	1 October 2021
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	3 locations across United States

Drugs / interventions tested

• Positive Processes and Transition to Health (PATH)

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

Case Western Reserve University

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder or Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Affective Updating Task (Pe et al., 2013; Pe, Raes, et al., 2013) Primary · Score at 6 weeks (immediately post treatment)

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).

Group	Value	95% CI
Receive PATH Therapy	0.54	± 0.23

Idiographic Behavioral Approach Task Primary · Score at 6 weeks (immediately post treatment)

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 S

Group	Value	95% CI
Receive PATH Therapy	25.65	± 22.47

Probabilistic Reward Task (Pizzagalli et al., 2005) Primary · Score at 6 weeks (immediately post treatment)

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 altern

Group	Value	95% CI
Receive PATH Therapy	-.03	± .25

Posttraumatic Cognitions Inventory (Foa et al., 1999) Secondary · Score at 6 weeks (immediately post treatment)

The Posttraumatic Cognitions Inventory (PTCI; Foa et al., 1999) is a self-report that measures negative posttraumatic stressor-related thoughts that can contribute to the development and maintenance of PTSD. The measure includes 33 items grouped into three subscales. The 21-item Negative Cognitions about Self scale measures negative self-perception since the traumatic event. The 7-item Negative Cognitions about the World subscale evaluates mistrust of others and perceptions of danger. The 5-item Self Blame scale measures self-blame since the traumatic incident. All items are measured on a scal

Group	Value	95% CI
Receive PATH Therapy	102.05	± 43.14

Behavioral Activation for Depression Scale (Kanter et al., 2006) Secondary · Score at 6 weeks (immediately post treatment)

Behavioral Activation for Depression Scale (Secondary Measure; BADS; Kanter et al., 2006) is a 25- item self-report of approach and avoidance in cognitive and behavioral domains not specific to depression. Items are rated from 0 = Not at all to 6 = Completely. The measure contains four subscales which include Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. Total scores, which range from 0-150 are calculated by summing the four subscales. A higher score indicates higher behavioral activation and lower scores indicate more depressive symptoms. The BADS has good f

Group	Value	95% CI
Receive PATH Therapy	106.5	± 24.97

Snaith-Hamilton Pleasure Scale (Snaith et al., 1995) Secondary · Score at 6 weeks (immediately post treatment)

Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995). The SHAPS is a 14- item self-report measuring the capacity to experience pleasure. On a four-point scale (1 = Strongly Agree to 4 = Strongly Disagree), varying statements are rated (e.g., "I would find pleasure in small things"; "I would find pleasure in a telephone call from a friend"). The measure has good convergent and discriminant validity and reflects a unidimensional construct of anhedonia (Leventhal et al., 2006; Nakonezny et al., 2010). Total scores are measured on a scale from 14 to 56 (14 = severe anhedonia, 56 = no anhedo

Group	Value	95% CI
Receive PATH Therapy	21.79	± 2.69

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.