Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries
NCT ID: NCT06233656
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2024-04-30
2027-03-28
Brief Summary
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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.
Detailed Description
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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 120 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acceptance and commitment therapy (ACT) 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.
Acceptance 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.
Wait-list control group
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.
No interventions assigned to this group
Interventions
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Acceptance 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.
Eligibility Criteria
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Inclusion Criteria
* having at least mild depressive symptoms as measured by the PHQ-9 (scores ≥ 5)
* having a web-enabled device (e.g., a computer or a smartphone) with internet access
Exclusion Criteria
* having suicidal intent or attempts in the past 6 months
* having psychiatric hospitalizations in the previous 2 years
* having a diagnosis with bipolar disorder or psychotic disorders (e.g., schizophrenia)
* having a prior experience with acceptance and commitment therapy
18 Years
ALL
No
Sponsors
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The Craig H. Neilsen Foundation
OTHER
University of South Florida
OTHER
Responsible Party
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Areum Han
Associate Professor
Principal Investigators
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Areum Han, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Other Identifiers
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1077500
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
300012385
Identifier Type: -
Identifier Source: org_study_id