Clinical trial NCT06233656: Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries
Official title: Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries: Testing Efficacy and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Spinal Cord Injuries
Keywords: Acceptance and Commitment Therapy
Depression
Mindfulness
Spinal cord injuries
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2024-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* community-dwelling adults (aged 18 years or older) living with spinal cord injuries
* 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 cognitive deficits or language barriers that might impede study participation
* 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

Primary outcomes:
measure: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
Secondary outcomes:
measure: 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
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Perceived Stress Scale - 10 (PSS-10)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: 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
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: 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
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the SCI-QOL Resilience Short form
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: 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)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: 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)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: 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)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: Change from baseline to immediately after the intervention (or 2 weeks) and 2 month follow-up on the Cognitive Fusion Questionnaire -7 (CFQ-7)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Engaged Living Scale -9 (ELS-9)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: 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)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
measure: Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Satisfaction with Life Scale (SWLS)
timeFrame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Areum Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: