DepressionNCT05725161
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
A study testing Acceptance and commitment therapy (ACT) in people with Depression and Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Spinal Cord Injuries
- What is being tested?
- Acceptance and commitment therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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
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.
Read the 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.
- Conditions
- Depression, Spinal Cord Injuries
- Being tested
- Acceptance and commitment therapy (ACT), Wait-list control group with psychoeducation materials provided
- Keywords
- Acceptance and Commitment Therapy, Anxiety, Depression, Grief, Mindfulness, Resilience, Self-compassion, Stress, Spinal cord injuries, Quality of life
- Medical subject headings
- Depression, Spinal Cord Injuries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapy (ACT)Behavioural
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 providedBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | 8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided Receives: Behavioral: Acceptance and commitment therapy (ACT) |
| Wait-list control group with psychoeducation materials provided | Other | Care as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends Receives: Behavioral: Wait-list control group with psychoeducation materials provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to immediately after the intervention and 2 month follow-up
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to immediately after the intervention and 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start8 Mar 2023
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Paralyzed Veterans of America
- Responsible party
- Principal investigator, Areum Han, University of Alabama at Birmingham
- Investigators
- Areum Han, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725161
- Sponsor's protocol ID
- 3191
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han A, Wilroy JD, Yuen HK, Jenkins J, Hawkins J. Videoconference-delivered acceptance and commitment therapy for depressed individuals with spinal cord injury sustained within the past 5 years: A pilot randomized controlled trial. Rehabil Psychol. 2026 Aug;71(3):395-403. doi: 10.1037/rep0000642. Epub 2025 Dec 1.
PubMed 41325142
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05725161
- Acronym / sponsor ID
- 3191
- Conditions
- Depression, Spinal Cord Injuries
- Keywords
- Acceptance and Commitment Therapy, Anxiety, Depression, Grief, Mindfulness, Resilience, Self-compassion, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Paralyzed Veterans of America
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | Behavioral: Acceptance and commitment therapy (ACT)8 weekly ACT sessions individually guided by a trained coach through Zoom videoconferencing with psychoeducation materials provided |
| Wait-list control group with psychoeducation materials provided | Other | Behavioral: Wait-list control group with psychoeducation materials providedCare as usual with psychoeducation materials provided during the study period and ACT sessions provided after the study period ends |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Acceptance and commitment therapy (ACT) group |
| Wait-list control group with psychoeducation materials providedThe 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 | Behavioural | Wait-list control group with psychoeducation materials provided |
Primary outcome
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Derived from this study: PubMed 41325142Han A, Wilroy JD, Yuen HK, Jenkins J, Hawkins J. Videoconference-delivered acceptance and commitment therapy for depressed individuals with spinal cord injury sustained within the past 5 years: A pilot randomized controlled trial. Rehabil Psychol. 2026 Aug;71(3):395-403. doi: 10.1037/rep0000642. Epub 2025 Dec 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areum Han, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy (ACT) in people with Depression and Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05725161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.