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Behavioural Intervention
Acceptance and commitment therapy (ACT) group for Spinal Cord Injury
N/A
Waitlist Available
Led By Areum Han, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
community-dwelling adults (aged 18 years or older) living with spinal cord injuries
having at least mild depressive symptoms as measured by the PHQ-9 (scores ≥ 5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
Awards & highlights
Study Summary
This trial aims to study the effects of an 8-week videoconferencing therapy program on improving mental health outcomes in individuals living with spinal cord injury (SCI) who are experiencing depressive symptoms. The
Who is the study for?
This trial is for adults over 18 with spinal cord injuries who feel at least mildly depressed, as shown by a PHQ-9 score of 5 or more. Participants need internet access and a device like a computer or smartphone to join the videoconferencing sessions.Check my eligibility
What is being tested?
The study tests if Acceptance and Commitment Therapy (ACT) delivered through video calls can help improve mental health in people with spinal cord injuries and depression. It compares an 8-week ACT program with a wait-list group that continues usual care.See study design
What are the potential side effects?
ACT typically doesn't have physical side effects but may bring up uncomfortable emotions as participants work through their thoughts and feelings related to their injury and life changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult living with a spinal cord injury.
Select...
I have mild or more severe depression symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Patient Health Questionnaire-9 (PHQ-9)
Secondary outcome measures
Change from baseline to immediately after the intervention (or 2 weeks) and 2 month follow-up on the Cognitive Fusion Questionnaire -7 (CFQ-7)
Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Action and Acceptance Questionnaire-II (AAQ-II)
Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Generalized Anxiety Disorder-7 (GAD-7)
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Acceptance and commitment therapy (ACT) groupExperimental Treatment1 Intervention
The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up.
Group II: Wait-list control groupActive Control1 Intervention
The wait-list control group will maintain his or her own care as usual during the study period and receive eight individual ACT sessions after study participation ends.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,279,924 Total Patients Enrolled
The Craig H. Neilsen FoundationOTHER
55 Previous Clinical Trials
2,815 Total Patients Enrolled
Areum Han, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
7 Previous Clinical Trials
140 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for patients to participate in this clinical trial?
"I apologize for the confusion. According to the information on clinicaltrials.gov, this particular study is currently not actively seeking participants. It was initially posted on April 30th, 2024 and last modified on January 27th, 2024. However, please note that there are currently 2110 other ongoing clinical trials actively recruiting individuals at this time."
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