Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05725161
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-02-02
Brief Title:
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Acceptance and Commitment Therapy Supplemented With Psychoeducation for Improving Mental Health of Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy ACT on mental health outcomes in individuals living with spinal cord injuries SCI A total of 40 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing The wait-list group will receive ACT sessions after the study period ends We will provide psychoeducation materials related to SCI as supplemental resources to both groups Mental health outcomes using self-reported questionnaires will be collected at pretest posttest and 2-month follow-up Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes eg depression and ACT processes eg psychological flexibility at posttest and 2-month follow-up compared to the wait-list control group provided with psychoeducation materials alone Interviews will be conducted at posttest to explore the participants experiences in ACT
Detailed Description:
This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy ACT on mental health outcomes in individuals living with spinal cord injuries SCI A total of 40 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing The wait-list group will receive ACT sessions after the study period ends We will provide psychoeducation materials related to SCI as supplemental resources to both groups Mental health outcomes using self-reported questionnaires will be collected at pretest posttest and 2-month follow-up Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in depression primary outcome secondary mental health outcomes eg anxiety stress and grief and ACT processes eg psychological flexibility at posttest and 2-month follow-up compared to the wait-list control group provided with psychoeducation materials alone Interviews will be conducted at posttest to explore the participants experiences in ACT
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