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

Acceptance and Commitment Therapy Supplemented With Psychoeducation for Improving Mental Health of Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years

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.

Study Overview

• Status: Completed
• Conditions: Depression; Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Acceptance and commitment therapy (ACT); Behavioral: Wait-list control group with psychoeducation materials provided

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and commitment therapy (ACT) group; 8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided	Behavioral: 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.
Other: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7	The Generalized Anxiety Disorder-7 is a 7-item questionnaire assessing anxiety on a scale of 0 to 3. Scores range from 0 to 21. Higher scores indicate greater anxiety.	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	The Perceived Stress Scale is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress.	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	World Health Organization Quality of Life - Psychological health component has 6 items measuring psychological quality of life on scale of 1 to 5. Scores range from 6 to 30. Higher scores denote higher quality of life in terms of psychological health.	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	SCI-QOL Grief and Loss Short form has nine items assessing grief and loss due to SCI on a scale of 1 to 5. Scores range from 9 to 45, and higher scores indicate more grief and loss.	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	SCI-QOL Resilience Short form has eight items assessing resilience on a scale of 1 to 5. Scores range from 8 to 40, and higher scores indicate greater resilience.	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 Self-Compassion Scale- Short Form	Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion on a scale of 1 to 5. Scores range from 12 to 60. Higher scores indicate higher levels of self-compassion.	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 Action and Acceptance Questionnaire-II	Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility on a scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate poor psychological flexibility.	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 Cognitive Fusion Questionnaire	Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion on scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate greater levels of cognitive fusion.	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 Engaged Living Scale	Engaged Living Scale -9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values and life fulfillment on a scale of 1 to 5. The total scores range from 9 to 45, and higher scores indicate increased clarity and engagement with personal values and greater life fulfillment.	Change from baseline to immediately after the intervention and 2 month follow-up

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Paralyzed Veterans of America
• Investigators: Principal Investigator: Areum Han, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): February 18, 2025
• Study Completion (Actual): February 18, 2025

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Acceptance and Commitment Therapy; Anxiety; Stress; Quality of life; Mindfulness; Resilience; Self-compassion; Spinal cord injuries; Grief
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Trauma, Nervous System; Spinal Cord Diseases; Depression; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 3191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No