RECRUITING

Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries: Testing Efficacy and Mechanisms of Change

Quick Facts

Study Start:2024-04-30
Study Completion:2027-03-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06233656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * community-dwelling adults (aged 18 years or older) living with spinal cord injuries
  2. * having at least mild depressive symptoms as measured by the PHQ-9 (scores ≥ 5)
  3. * having a web-enabled device (e.g., a computer or a smartphone) with internet access
  1. * having cognitive deficits or language barriers that might impede study participation
  2. * having suicidal intent or attempts in the past 6 months
  3. * having psychiatric hospitalizations in the previous 2 years
  4. * having a diagnosis with bipolar disorder or psychotic disorders (e.g., schizophrenia)
  5. * having a prior experience with acceptance and commitment therapy

Contacts and Locations

Study Contact

Areum Han, PhD
CONTACT
205-975-2882
ahan@uab.edu

Principal Investigator

Areum Han, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Areum Han, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-30
Study Completion Date2027-03-28

Study Record Updates

Study Start Date2024-04-30
Study Completion Date2027-03-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Depression
  • Spinal Cord Injuries