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

Primary Purpose

Depression, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and commitment therapy (ACT)
Wait-list control group with psychoeducation materials provided
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Acceptance and Commitment Therapy, Anxiety, Depression, Grief, Mindfulness, Resilience, Self-compassion, Stress, Spinal cord injuries, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Acceptance and commitment therapy (ACT) group

Wait-list control group with psychoeducation materials provided

Arm Description

8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided

Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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 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 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 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 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 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.

Full Information

First Posted
February 2, 2023
Last Updated
March 8, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Paralyzed Veterans of America
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1. Study Identification

Unique Protocol Identification Number
NCT05725161
Brief Title
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Paralyzed Veterans of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 40 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.
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 40 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Spinal Cord Injuries
Keywords
Acceptance and Commitment Therapy, Anxiety, Depression, Grief, Mindfulness, Resilience, Self-compassion, Stress, Spinal cord injuries, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and commitment therapy (ACT) group
Arm Type
Experimental
Arm Description
8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided
Arm Title
Wait-list control group with psychoeducation materials provided
Arm Type
Other
Arm Description
Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and commitment therapy (ACT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait-list control group with psychoeducation materials provided
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the Perceived Stress Scale
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the World Health Organization Quality of Life - Psychological health component
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
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
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the SCI-QOL Resilience Short form
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the Self-Compassion Scale- Short Form
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the Action and Acceptance Questionnaire-II
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
Change from baseline to immediately after the intervention and 2 month follow-up on the Cognitive Fusion Questionnaire
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Areum Han, PhD
Phone
205-975-2882
Email
ahan@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areum Han, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areum Han, PhD
Phone
205-975-2882
Email
ahan@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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