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| Name | Class |
|---|---|
| Paralyzed Veterans of America | OTHER |
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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | 8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided |
|
| Wait-list control group with psychoeducation materials provided | Other | Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and commitment therapy (ACT) | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Areum Han, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41325142 | Derived | Han A, Wilroy JD, Yuen HK, Jenkins J, Hawkins J. Videoconference-delivered acceptance and commitment therapy for depressed individuals with spinal cord injury sustained within the past 5 years: A pilot randomized controlled trial. Rehabil Psychol. 2025 Dec 1. doi: 10.1037/rep0000642. Online ahead of print. |
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| Wait-list control group with psychoeducation materials provided | Behavioral | 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 |
|
| 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 |
| ID | Term |
|---|---|
| D003863 | Depression |
| D013119 | Spinal Cord Injuries |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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