Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries

NCT06233656 | Active Not Recruiting

• 2 other identifiers: 3000123851077500
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Spinal Cord Injuries

Keywords

Acceptance and Commitment Therapy; Depression; Mindfulness; Spinal cord injuries

Outcome Measures

Primary Outcomes (1)

• Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Patient Health Questionnaire-9 (PHQ-9)

  The PHQ-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 (or 8 weeks) and 2 month follow-up

Secondary Outcomes (13)

• 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

  Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

• Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Generalized Anxiety Disorder-7 (GAD-7)

  Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

• Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Perceived Stress Scale - 10 (PSS-10)

  Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

• 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

  Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

• 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

  Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

Study Arms (2)

Acceptance and commitment therapy (ACT) group

EXPERIMENTAL

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.

Behavioral: Acceptance and commitment therapy (ACT)

Wait-list control group

NO INTERVENTION

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.

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.

Acceptance and commitment therapy (ACT) group

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Depression; Spinal Cord Injuries

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Areum Han, PhD

  University of South Florida

  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: January 15, 2024
• First Posted: January 31, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)