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| ID | Type | Description | Link |
|---|---|---|---|
| 1077500 | Other Grant/Funding Number | Craig H. Neilsen Foundation |
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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
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Living with spinal cord injury (SCI) can have a significant negative impact on an individual's mental health and restrict participation in personally valued activities and roles. Acceptance and commitment therapy (ACT) is an evidence-based approach that can lessen symptoms of mental health disorders (e.g., depressive symptoms) and improve quality of life through mindfulness and acceptance processes and behavior change processes for valued living. Evidence for ACT for individuals living with SCI, however, is limited to a very few studies that involved in-person group-based ACT and did not focus on depressed individuals with SCI.
The primary goal of this study is to evaluate the effects of an 8-week videoconferencing ACT program on improving mental health outcomes in depressed individuals living with SCI. The primary hypotheses are that the ACT group will show improvements in depressive symptoms at posttest and 2-month follow-up compared to the wait-list control group. Investigators will invite 120 individuals living with SCI and reporting depressive symptoms and randomly assign them to either the ACT group or the wait-list control group. The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up. The wait-list control group will continue his or her own care as usual during the study period and have the option to receive eight individual ACT sessions after study participation ends. Data will be collected at pretest, posttest, and 2-month follow-up and compared between the ACT group and the control group over time.
About 40% of individuals living with SCI report depressive symptoms and other mental health symptoms, and mental health disorders following SCI are associated with negative long-term outcomes. Managing uncomfortable or painful thoughts and emotions arising from functional limitations and accepting changed lives while moving forward for valued living through ACT skill practice will help individuals with SCI alleviate symptoms of mental health conditions, promote engagement in personally valued activities, and improve quality of life.
Living with spinal cord injury (SCI) can have a significant negative impact on an individual's mental health and restrict participation in personally valued activities and roles. About 40% of individuals with SCI report depressive symptoms and other mental health symptoms, which are associated with negative long-term outcomes.
Acceptance and commitment therapy (ACT) is an empirically supported transdiagnostic approach that can mitigate symptoms of mental health disorders and improve quality of life through mindfulness and acceptance processes and behavior change processes for valued living. ACT is based on the psychological flexibility model involving six processes that serve as a mechanism of change (i.e., acceptance, cognitive defusion, being present, observing self, values, and committed action). Evidence for ACT for individuals with SCI, however, is limited to a very few studies that involved in-person group-based ACT and did not focus on depressed individuals with SCI.
This project aims to test the efficacy of an 8-week videoconferencing ACT program for improving mental health in depressed individuals living with SCI. The hypotheses are that the ACT group will show improvements in depressive symptoms (the primary outcome), secondary mental health outcomes (e.g., anxiety, stress, and grief), and ACT processes (e.g., psychological flexibility and engaged living) at posttest and 2-month follow-up compared to the wait-list control group. Also, the project aims to examine the mediating effects of the ACT psychological flexibility processes on reducing depressive symptoms in individuals living with SCI.
This study will use a two-arm parallel-group, randomized controlled trial design. The investigators will recruit approximately 120-140 depressed individuals living with SCI and randomly assign them to either the ACT group or the wait-list control group. The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up. The wait-list control group will maintain his or her own care as usual during the study period and have the option to receive eight individual ACT sessions after study participation ends. Data will be collected at pretest, posttest, and 2-month follow-up. The investigators will use generalized linear mixed-effects models to examine the relative impact on the ACT group compared to the wait-list control group at posttest and 2-month follow-up. The mediation analysis will consist of the outcome model and the mediator model. After fitting the models, the investigators will estimate direct effect and indirect effect (i.e., the mediated effect).
Managing uncomfortable or painful thoughts and emotions arising from functional limitations and accepting changed lives while moving forward for valued living through ACT skill practice will help individuals with SCI alleviate symptoms of mental health conditions, promote engagement in personally valued activities, and improve quality of life. The investigators expect the findings of this study to contribute to the limited evidence for internet-delivered ACT in individuals living with SCI and lay the necessary groundwork to provide important knowledge and guidance for future clinical trials and practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up. |
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| Wait-list control group | No Intervention | The wait-list control group will maintain his or her own care as usual during the study period and receive eight individual ACT sessions after study participation 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Patient Health Questionnaire-9 (PHQ-9) | The PHQ-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 (or 8 weeks) and 2 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Depression Short form | The SCI-QOL Depression Short form (a back-up measure of depressive symptoms) has 10 items assessing the severity of depressive symptoms in individuals living with SCI on a scale of 1 (never) to 5 (always). Scores range from 10 to 50, and higher scores indicate higher levels of depressive symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Areum Han, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
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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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| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Generalized Anxiety Disorder-7 (GAD-7) | The GAD-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 (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Perceived Stress Scale - 10 (PSS-10) | The PSS-10 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 (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the World Health Organization Quality of Life (WHOQOL) - Psychological health component | The WHOQOL - 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 (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Grief and Loss Short form | The 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 (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the SCI-QOL Resilience Short form | The 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 (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Self-Compassion Scale - Short Form (SCS-SF) | The SCS-SF 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 (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Multidimensional Psychological Flexibility Inventory - 24 (MPFI-24) | The MPFI-24 is a 24-item self-report questionnaire measuring psychological flexibility /inflexibility on a scale of 1 to 6. Scores on pairs of items are averaged to represent each of the 12 specific dimensions of psychological flexibility and inflexibility. The averages of the 6 flexibility subscales can be averaged to create a composite representing global flexibility (i.e., higher scores indicates greater psychological flexibility). Similarly, the averages of the 6 inflexibility subscales can be averaged to create a global inflexibility composite (i.e., higher scores indicate greater psychological inflexibility). | Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Action and Acceptance Questionnaire-II (AAQ-II) | The AAQ-II is a 7-item self-report questionnaire measuring experiential avoidance on a scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate greater experiential avoidance. | Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 2 weeks) and 2 month follow-up on the Cognitive Fusion Questionnaire -7 (CFQ-7) | The CFQ-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 (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Engaged Living Scale -9 (ELS-9) | The ELS-9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values 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. | Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) | The FFMQ-SF is a 24-item questionnaire assessing five facets of mindfulness (i.e., observing, describing, acting with awareness, non-judgment of inner experiences, and non-reactivity to inner experiences) on a scale of 1 (never or very rarely true) to 5 (very often or always true). Facet scores range from 5 to 25 (except for the observing facet, which ranges from 4 to 20), and higher scores reflect higher levels of mindfulness. | Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up |
| Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Satisfaction with Life Scale (SWLS) | The SWLS is a short 5-item questionnaire assessing satisfaction with one's life on a scale of 1 (Strongly disagree) to 7 (Strongly agree). Scores range from 5 to 35 and higher scores reflect higher life satisfaction. | Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up |
| D009422 |
| Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |