Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries

Depression Clinical Trial

Official title: Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries: Testing Efficacy and Mechanisms of Change

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 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. ;

Related Conditions & MeSH terms

• Depression
• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT06233656
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Contact: Areum Han, PhD
• Phone: 205-975-2882
• Email: ahan@uab.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Completion date: March 28, 2027