Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752072
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2021-02-08
Brief Title:
RESTORE Trial A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation ESTAIR for Veterans With CPTSD
Sponsor:
Combat Stress
Organization:
Combat Stress
Study Overview
Official Title:
RESTORE Trial A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation ESTAIR vs Treatment as Usual TAU for Complex Posttraumatic Stress Disorder CPTSD in Military Personnel
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
Complex Post traumatic Stress Disorder CPTSD is now recognized as a separate trauma-based psychological condition to PTSD CPTSD is a broader diagnosis that includes the core PTSD symptoms re-experiencing in the here and now avoidance and sense of current threat plus an additional set of symptoms that are collectively referred to as disturbances in self-organisation DSO DSO symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters difficulties in affect regulation AR negative self-concept NSC and disturbances in relationships DR
There are no effective interventions for CPTSD It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD The present study will be one of the first to investigate the effectiveness of a novel modular intervention for CPTSD Enhanced Skills Training in Affective and Interpersonal Regulation ESTAIR is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules ie specific number of sessions targeting specific clusters of symptoms
The overall aim of this study is to establish the feasibility acceptability and preliminary effects of ESTAIR in treating CPTSD To achieve these aims the investigators will conduct a pilot randomised controlled trial RCT with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD and with two treatment arms ESTAIR vs a treatment-as-usual TAU condition
There are no effective interventions for CPTSD It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD The present study will be one of the first to investigate the effectiveness of a novel modular intervention for CPTSD Enhanced Skills Training in Affective and Interpersonal Regulation ESTAIR is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules ie specific number of sessions targeting specific clusters of symptoms
The overall aim of this study is to establish the feasibility acceptability and preliminary effects of ESTAIR in treating CPTSD To achieve these aims the investigators will conduct a pilot randomised controlled trial RCT with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD and with two treatment arms ESTAIR vs a treatment-as-usual TAU condition
Detailed Description:
None
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 |
|---|---|---|---|
| FiMT190429EDU | OTHER_GRANT | Forces in Mind | None |