Acceptance and Commitment Therapy Supplemented With Psychoeducation for Improving Mental Health of Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9
Study Overview
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 34 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 (e.g., depression) and ACT processes (e.g., 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 34 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 (e.g., anxiety, stress, and grief), and ACT processes (e.g., 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •community-dwelling adults (aged 18 years or older) living with spinal cord injuries sustained within 5 years
- •having at least mild depression measured by the Patient Health Questionnaire-9
- •having a computer or a smartphone and internet access at home
Exclusion Criteria
- •having cognitive deficits or language barriers that might impede study participation
- •having suicidal attempts within 6 months;
- •having a prior experience with acceptance and commitment therapy
Arms & Interventions
Acceptance and commitment therapy (ACT) group
8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided
Intervention: Acceptance and commitment therapy (ACT) (Behavioral)
Wait-list control group with psychoeducation materials provided
Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends
Intervention: Wait-list control group with psychoeducation materials provided (Behavioral)
Outcomes
Primary Outcomes
Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9
Time Frame: Change from baseline to immediately after the intervention and 2 month follow-up
The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.
Secondary Outcomes
- Change from baseline to immediately after the intervention and 2 month follow-up on the Perceived Stress Scale(Change from baseline to immediately after the intervention and 2 month follow-up)
- Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7(Change from baseline to immediately after the intervention and 2 month follow-up)
- Change from baseline to immediately after the intervention and 2 month follow-up on the World Health Organization Quality of Life - Psychological health component(Change from baseline to immediately after the intervention and 2 month follow-up)
- Change from baseline to immediately after the intervention and 2 month follow-up on the Self-Compassion Scale- Short Form(Change from baseline to immediately after the intervention and 2 month follow-up)
- 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)
- Change from baseline to immediately after the intervention and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Grief and Loss Short form(Change from baseline to immediately after the intervention and 2 month follow-up)
- Change from baseline to immediately after the intervention and 2 month follow-up on the SCI-QOL Resilience Short form(Change from baseline to immediately after the intervention and 2 month follow-up)
- 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)
- Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale(Change from baseline to immediately after the intervention and 2 month follow-up)
Investigators
Areum Han
Associate Professor
University of Alabama at Birmingham