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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05725161
Collaborator
Paralyzed Veterans of America (Other)
60
1
2
24
2.5

Study Details

Study Description

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 60 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acceptance and commitment therapy (ACT)
  • Behavioral: Wait-list control group with psychoeducation materials provided
N/A

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 60 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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Acceptance and Commitment Therapy Supplemented With Psychoeducation for Improving Mental Health of Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9 [Change from baseline to immediately after the intervention and 2 month follow-up]

    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.

Secondary Outcome Measures

  1. 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]

    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.

  2. 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]

    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.

  3. 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]

    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.

  4. 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]

    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.

  5. 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]

    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.

  6. Change from baseline to immediately after the intervention and 2 month follow-up on the Self-Compassion Scale- Short Form [Change from baseline to immediately after the intervention and 2 month follow-up]

    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.

  7. Change from baseline to immediately after the intervention and 2 month follow-up on the Action and Acceptance Questionnaire-II [Change from baseline to immediately after the intervention and 2 month follow-up]

    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.

  8. Change from baseline to immediately after the intervention and 2 month follow-up on the Cognitive Fusion Questionnaire [Change from baseline to immediately after the intervention and 2 month follow-up]

    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.

  9. Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale [Change from baseline to immediately after the intervention and 2 month follow-up]

    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.

  10. Change from baseline to immediately after the intervention and 2-month follow-up on the Mindful Attention Awareness Scale [Change from baseline to immediately after the intervention and 2 month follow-up]

    Mindful Attention Awareness Scale is a 15-item scale assessing dispositional mindfulness on a scale of 1 to 6. Scores range from 15 to 90, and higher scores reflect higher levels of dispositional mindfulness.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 thoughts and attempts;

  • having a prior experience with acceptance and commitment therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • Paralyzed Veterans of America

Investigators

  • Principal Investigator: Areum Han, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Areum Han, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05725161
Other Study ID Numbers:
  • 3191
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Areum Han, Assistant Professor, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023