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

NCT05725161 | Completed

• 1 other identifier: 3191
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Spinal Cord Injuries

Keywords

Acceptance and Commitment Therapy; Anxiety; Depression; Grief; Mindfulness; Resilience; Self-compassion; Stress; Spinal cord injuries; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9

  The Patient Health Questionnaire-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 and 2 month follow-up

Secondary Outcomes (9)

• Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7

  Change from baseline to immediately after the intervention and 2 month follow-up

• Change from baseline to immediately after the intervention and 2 month follow-up on the Perceived Stress Scale

  Change from baseline to immediately after the intervention and 2 month follow-up

• Change from baseline to immediately after the intervention and 2 month follow-up on the World Health Organization Quality of Life - Psychological health component

  Change from baseline to immediately after the intervention and 2 month follow-up

• Change from baseline to immediately after the intervention and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Grief and Loss Short form

  Change from baseline to immediately after the intervention and 2 month follow-up

• Change from baseline to immediately after the intervention and 2 month follow-up on the SCI-QOL Resilience Short form

  Change from baseline to immediately after the intervention and 2 month follow-up

Study Arms (2)

Acceptance and commitment therapy (ACT) group

EXPERIMENTAL

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

Behavioral: Acceptance and commitment therapy (ACT)

Wait-list control group with psychoeducation materials provided

OTHER

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

Behavioral: Wait-list control group with psychoeducation materials provided

Interventions

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 with psychoeducation materials provided.

Acceptance and commitment therapy (ACT) group

Wait-list control group with psychoeducation materials provided 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

Wait-list control group with psychoeducation materials provided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Paralyzed Veterans of America: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Han A, Wilroy JD, Yuen HK, Jenkins J, Hawkins J. Videoconference-delivered acceptance and commitment therapy for depressed individuals with spinal cord injury sustained within the past 5 years: A pilot randomized controlled trial. Rehabil Psychol. 2025 Dec 1. doi: 10.1037/rep0000642. Online ahead of print.

  PMID: 41325142 DERIVED

MeSH Terms

Conditions

Depression; Spinal Cord Injuries; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Areum Han, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: March 8, 2023
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)