Positive Processes and Transition to Health (PATH)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Positive Processes and Transition to Health
BehavioralSee arm/group description for details regarding this intervention
Progressive Muscle Relaxation
BehavioralSee arm/group description for details regarding this intervention
Treatment groups
135 Participants
are divided into 2 treatment groupsGroup A: Positive Processes and Transition to Health (PATH)Experimental treatment 1 intervention
Group B: Progressive Muscle Relaxation (PMR)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Affective Updating Task
Measure updating of affective information in working memory
Time frame
Change from baseline score at 6 weeks (immediately post treatment)2
Idiographic Behavioral Approach Task
Use in vivo confrontation with feared or avoided stimuli measuring avoidance behavior
Time frame
Change from baseline score at 6 weeks (immediately post treatment)3
Probabilistic Reward Task
Assesses reward responsivity
Time frame
Change from baseline score at 6 weeks (immediately post treatment)Secondary outcomes
1
Posttraumatic Cognitions Inventory
Self-report of negative, overgeneralized stressor-related thoughts
Time frame
Change from baseline score at 6 weeks (immediately post treatment)2
Behavioral Activation for Depression Scale
Self-report of approach and avoidance in cognitive and behavioral domains (not specific to depression)
Time frame
Change from baseline score at 6 weeks (immediately post treatment)3
Snaith-Hamilton Pleasure Scale
Self-report measuring the capacity to experience pleasure
Time frame
Change from baseline score at 6 weeks (immediately post treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Western Reserve University
Lead sponsor
University of Washington
Collaborator
University of Delaware
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov