Depression, Spinal Cord Injuries
Conditions
Keywords
Acceptance and Commitment Therapy, Anxiety, Depression, Grief, Mindfulness, Resilience, Self-compassion, Stress, Spinal cord injuries, Quality of life
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.
Interventions
BEHAVIORALAcceptance and commitment therapy (ACT)
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.
BEHAVIORALWait-list control group with psychoeducation materials provided
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
Sponsors
Paralyzed Veterans of America
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 on the World Health Organization Quality of Life - Psychological health component | Change from baseline to immediately after the intervention and 2 month follow-up | 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 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 | 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 on the SCI-QOL Resilience Short form | Change from baseline to immediately after the intervention and 2 month follow-up | 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 on the Generalized Anxiety Disorder-7 | Change from baseline to immediately after the intervention and 2 month follow-up | 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 on the Action and Acceptance Questionnaire-II | Change from baseline to immediately after the intervention and 2 month follow-up | 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 on the Cognitive Fusion Questionnaire | Change from baseline to immediately after the intervention and 2 month follow-up | 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 on the Engaged Living Scale | Change from baseline to immediately after the intervention and 2 month follow-up | 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 on the Self-Compassion Scale- Short Form | Change from baseline to immediately after the intervention and 2 month follow-up | 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. |
Countries
United States
Outcome results
None listed