Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093906
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2023-10-17
Brief Title:
Positive Processes and Transition to Health PATH
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
Treatment of Stress-Related Psychopathology Targeting Maladaptive and Adaptive Event Processing
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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 PATHs 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
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 trials 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 060 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 engagementefficacy in intervention trials Second at least one of the secondary measures must show a moderate effect d 050 from pre- to post-treatment The investigators 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 eg Barth et al 2016 Cusak et al 2016
In the R33 phase if the investigators achieve the Go criteria the investigators will conduct a randomized controlled trial comparing PATH to PMR PMR is a commonly used control condition that is rated as credible and helpful by patients PMR will consist of six 60-90 minute sessions focusing on stress management
For the open trials 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 060 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 engagementefficacy in intervention trials Second at least one of the secondary measures must show a moderate effect d 050 from pre- to post-treatment The investigators 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 eg Barth et al 2016 Cusak et al 2016
In the R33 phase if the investigators achieve the Go criteria the investigators will conduct a randomized controlled trial comparing PATH to PMR PMR is a commonly used control condition that is rated as credible and helpful by patients PMR will consist of six 60-90 minute sessions focusing on stress management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4R33MH118401-03 | NIH | None | httpsreporternihgovquickSearch4R33MH118401-03 |