Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years

NCT ID: NCT05725161

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2025-02-18

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.

Conditions

Depression; Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acceptance and commitment therapy (ACT) group

8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided

Group Type: EXPERIMENTAL

Acceptance and commitment therapy (ACT)

Intervention Type: 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 with psychoeducation materials provided.

Wait-list control group with psychoeducation materials provided

Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends

Group Type: OTHER

Wait-list control group with psychoeducation materials provided

Intervention Type: BEHAVIORAL

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

Interventions

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 with psychoeducation materials provided.

Intervention Type: BEHAVIORAL

Wait-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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paralyzed Veterans of America

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Areum Han

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areum Han, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

3191

Identifier Type: -

Identifier Source: org_study_id