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Acceptance and Commitment Therapy for Depression in Spinal Cord Injury
N/A
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately after the intervention and 2 month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial studies effects of therapy & psychoeducation resources on mental health outcomes of individuals living with spinal cord injuries. 60 participants randomly assigned to either treatment or control group. Mental health outcomes measured and participants interviewed.
Who is the study for?
This trial is for adults over 18 who have had a spinal cord injury in the last 5 years and are experiencing mild depression. Participants need to have internet access, a computer or smartphone at home. It's not for those with cognitive deficits, language barriers that could affect participation, recent suicidal attempts, or previous ACT therapy experience.
What is being tested?
The study tests if acceptance and commitment therapy (ACT) via videoconferencing can improve mental health in people with spinal cord injuries when compared to a wait-list group given psychoeducation materials only. The ACT group will get weekly sessions for two months, followed by evaluations.
What are the potential side effects?
As ACT involves psychological counseling rather than medication, side effects may include emotional discomfort or distress during discussions about personal issues but typically do not involve physical side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to immediately after the intervention and 2 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediately after the intervention and 2 month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9
Secondary study objectives
Change from baseline to immediately after the intervention and 2 month follow-up on the Action and Acceptance Questionnaire-II
Change from baseline to immediately after the intervention and 2 month follow-up on the Cognitive Fusion Questionnaire
Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Wait-list control group with psychoeducation materials providedExperimental Treatment1 Intervention
Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends
Group II: Acceptance and commitment therapy (ACT) groupExperimental Treatment1 Intervention
8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and commitment therapy (ACT)
2022
N/A
~40
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,632 Previous Clinical Trials
2,304,939 Total Patients Enrolled
Paralyzed Veterans of AmericaOTHER
4 Previous Clinical Trials
127 Total Patients Enrolled
Areum Han, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
7 Previous Clinical Trials
189 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously undergone acceptance and commitment therapy.I am an adult who had a spinal cord injury within the last 5 years and live at home.You possess a personal computing device and internet connectivity in your domicile.You have been diagnosed with mild depression using the Patient Health Questionnaire-9.I am an adult who had a spinal cord injury within the last 5 years and live in the community.
Research Study Groups:
This trial has the following groups:- Group 1: Acceptance and commitment therapy (ACT) group
- Group 2: Wait-list control group with psychoeducation materials provided
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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