Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523023
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
An Integrated Online Program Using Psychoeducation and Expressive Writing for People With Probable Post-traumatic Stress Disorder and Coexisting Dissociative Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Integrated Online Program Using Psychoeducation and Expressive Writing for People With Probable Post-traumatic Stress Disorder and Coexisting Dissociative Symptoms a Pilot Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
To evaluate the feasibility acceptability safety and preliminary effects of an integrated online program with psychoeducation and expressive writing components for people with probable post-traumatic stress disorder PTSD and coexisting dissociative symptoms
Hypotheses to be tested
The program will be feasible acceptable and safe to participants When compared with the waitlist control group participants in the treatment group will report significantly lower PTSD symptom severity lower dissociative symptom severity and greater improvement on coping immediately post-intervention
Design and subjects
An assessor-blind two-arm randomised waitlist-controlled pilot study is proposed 90 community adults with significant PTSD and dissociative symptoms will be recruited
Instruments
The PTSD Checklist 5 Dissociative Experiences Scale-Taxon and Brief Coping Orientation to Problems Experienced inventory will be used Semi-structured interviews will be conducted for process evaluation
Intervention
A 10-week integrated online program with psychoeducational and expressive writing components
Main outcome measures
The primary outcome is PTSD symptom severity The secondary outcomes are dissociative symptom severity and coping The feasibility acceptability and safety of the program will also be examined
Data analysis Feasibility and acceptability of the program will be assessed by examining the attrition rate adherence rate duration of subject recruitment and post-program individual interviews Generalised estimating equations with covariate adjustments will be used to examine the preliminary effects of the program
Expected results
Adults in the community who experienced significant PTSD and dissociative symptoms will become more resourceful to cope with their traumatic experiences and show more improvements on PTSD and dissociative symptoms
To evaluate the feasibility acceptability safety and preliminary effects of an integrated online program with psychoeducation and expressive writing components for people with probable post-traumatic stress disorder PTSD and coexisting dissociative symptoms
Hypotheses to be tested
The program will be feasible acceptable and safe to participants When compared with the waitlist control group participants in the treatment group will report significantly lower PTSD symptom severity lower dissociative symptom severity and greater improvement on coping immediately post-intervention
Design and subjects
An assessor-blind two-arm randomised waitlist-controlled pilot study is proposed 90 community adults with significant PTSD and dissociative symptoms will be recruited
Instruments
The PTSD Checklist 5 Dissociative Experiences Scale-Taxon and Brief Coping Orientation to Problems Experienced inventory will be used Semi-structured interviews will be conducted for process evaluation
Intervention
A 10-week integrated online program with psychoeducational and expressive writing components
Main outcome measures
The primary outcome is PTSD symptom severity The secondary outcomes are dissociative symptom severity and coping The feasibility acceptability and safety of the program will also be examined
Data analysis Feasibility and acceptability of the program will be assessed by examining the attrition rate adherence rate duration of subject recruitment and post-program individual interviews Generalised estimating equations with covariate adjustments will be used to examine the preliminary effects of the program
Expected results
Adults in the community who experienced significant PTSD and dissociative symptoms will become more resourceful to cope with their traumatic experiences and show more improvements on PTSD and dissociative symptoms
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None