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Acceptance And Commitment Therapy

Sponsor:

University of South Florida

Code:

NCT06233656

Conditions

Depression

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acceptance and commitment therapy (ACT)

Study Details

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

Study ID

NCT06233656

Start date

Apr 30, 2024

Status verified date

Sep, 2025

Completion date

Mar 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance and commitment therapy (ACT) 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.

no intervention: Wait-list control group

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)

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.

Primary outcome 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) [ Time Frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up ]

Central Contacts and Locations

Central contacts

Areum Han, PhD

813-396-0524areumhan@usf.edu

Eva Okereke-Enechukwu

813-396-0524okerekeenech@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Areum Han, PhD

813-396-0524areumhan@usf.edu

Eva Okereke-Enechukwu

813-396-0524okerekeenech@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.