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Completed

NCT Number: NCT05725161

Acceptance and Commitment Therapy for 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.

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Key information

Conditions

Depression Anxiety Disorders Behavior Behavioral Symptoms Central Nervous System Diseases Mental Disorders Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 with psychoeducation materials provided.

Wait-list control group with psychoeducation materials provided

Behavioral

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Paralyzed Veterans of America

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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