Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years

Study Overview
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Brief Summary
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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 (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
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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 (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.

Official Title
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Acceptance and Commitment Therapy Supplemented With Psychoeducation for Improving Mental Health of Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years

Conditions
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Depression, Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Acceptance and commitment therapy (ACT)
* Behavioral: Wait-list control group with psychoeducation materials provided


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and commitment therapy (ACT) group<br>8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided | Behavioral: Acceptance and commitment therapy (ACT)<br>* Participants assigned to the ACT group will receive 8 weekly individual ACT sessions guided by a coach for one hour per week over 8 weeks through Zoom videoconferencing with psychoeducation materials provided.<br>|
| Other: Wait-list control group with psychoeducation materials provided<br>Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends | Behavioral: Wait-list control group with psychoeducation materials provided<br>* The wait-list control group will receive care as usual with psychoeducation materials provided during the study period and receive ACT sessions after the study period ends<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9 | 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. | Change from baseline to immediately after the intervention and 2 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7 | The Generalized Anxiety Disorder-7 is a 7-item questionnaire assessing anxiety on a scale of 0 to 3. Scores range from 0 to 21. Higher scores indicate greater anxiety. | 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 Perceived Stress Scale | The Perceived Stress Scale is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress. | 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 | World Health Organization Quality of Life - Psychological health component has 6 items measuring psychological quality of life on scale of 1 to 5. Scores range from 6 to 30. Higher scores denote higher quality of life in terms of psychological health. | 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 | SCI-QOL Grief and Loss Short form has nine items assessing grief and loss due to SCI on a scale of 1 to 5. Scores range from 9 to 45, and higher scores indicate more grief and loss. | 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 | SCI-QOL Resilience Short form has eight items assessing resilience on a scale of 1 to 5. Scores range from 8 to 40, and higher scores indicate greater resilience. | 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 | Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion on a scale of 1 to 5. Scores range from 12 to 60. Higher scores indicate higher levels of self-compassion. | 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 | Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility on a scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate poor psychological flexibility. | 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 | Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion on scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate greater levels of cognitive fusion. | 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 | Engaged Living Scale -9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values and life fulfillment on a scale of 1 to 5. The total scores range from 9 to 45, and higher scores indicate increased clarity and engagement with personal values and greater life fulfillment. | Change from baseline to immediately after the intervention and 2 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Depression, Acceptance and Commitment Therapy, Grief, Mindfulness, Resilience, Self-compassion, Stress, Spinal cord injuries, Quality of life