Spinal Cord InjuriesNCT04670406
A Guided Online ACT Intervention Combined With Psychoeducation for People With Spinal Cord Injury
A study testing acceptance and commitment therapy (ACT) combined with psychoeducation in people with Spinal Cord Injuries and Psychological Distress, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this preliminary study is to examine the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on people with spinal cord injury (SCI) who experience psychological distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Psychological Distress
- What is being tested?
- acceptance and commitment therapy (ACT) combined with psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2021to 23 Aug 2021
- 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 (age 18 or over) living in the community who had a spinal cord injury
- suffering at least mild symptoms of psychological distress measured by the DASS-21
- having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
- being able to provide informed consent by understanding the nature of study participation.
Who cannot join
- having cognitive, physical, or sensory deficits, or language barriers (non- English communicator) that impede study participation
- receiving a psychological therapy currently
- having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
- taking antipsychotic or anticonvulsant medication at the time of recruitment
- having the possibility of study dropouts due to other medical conditions
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: A Guided Online Acceptance and Commitment Therapy (ACT) Intervention Combined With Psychoeducation for People With Spinal Cord Injury: A Preliminary Study
The purpose of this preliminary study is to examine the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on people with spinal cord injury (SCI) who experience psychological distress.
Read the detailed description
This project will employ a one-group pretest-posttest design to investigate the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on quality of life and mental health of people with spinal cord injury (SCI) who experience psychological distress. After the pretest evaluation, eligible participants will receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and Spinal Cord Injury - Quality of Life (SCI-QOL). A one-time interview at the completion of the 8 sessions will be conducted to explore participants' experiences in the sessions.
- Conditions
- Spinal Cord Injuries, Psychological Distress
- Being tested
- acceptance and commitment therapy (ACT) combined with psychoeducation
- Keywords
- Acceptance and Commitment Therapy, Quality of life, Spinal cord injury, Psychological distress, Depression, Anxiety, Stress, Mindfulness, Self-compassion
- Medical subject headings
- Spinal Cord Injuries, Depression, 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) combined with psychoeducationBehavioural
Participants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing.
| Study group | Role | What they receive |
|---|---|---|
| acceptance and commitment therapy (ACT) combined with psychoeducation | Experimental | Participants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. Receives: Behavioral: acceptance and commitment therapy (ACT) combined with psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety and Stress Scale (DASS) - 21
The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.
Measured: Change from baseline to 8 weeks
World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component
WHOQOL-BREF - psychological health component has 6 items measuring: bodily image and appearance; negative feelings; positive feelings; self-esteem; spirituality / personal beliefs; and thinking, learning, memory and concentration. Higher scores denote higher quality of life in terms of psychological health.
Measured: Change from baseline to 8 weeks
Secondary outcomes (7)
Self-Compassion Scale- Short Form (SCS-SF)
Self-Compassion Scale- Short Form (SCS-SF) has 12 items assessing the relation of self-compassion to positive psychological health. Higher scores indicate higher levels of self-compassion.
Measured: Change from baseline to 8 weeks
Engagement in Meaningful Activities Survey (EMAS)
The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. Higher scores indicate greater levels of engagement in meaningful activities.
Measured: Change from baseline to 8 weeks
Action and Acceptance Questionnaire (AAQ)-II
The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.
Measured: Change from baseline to 8 weeks
Cognitive Fusion Questionnaire (CFQ)-7
The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.
Measured: Change from baseline to 8 weeks
Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form
SCI-QOL Grief and Loss Short form has 9 items assessing grief and loss due to spinal cord injuries. Higher scores indicate more grief/loss.
Measured: Change from baseline to 8 weeks
Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form
SCI-QOL Resilience Short form has 8 items assessing resilience. Higher scores indicate more resilience.
Measured: Change from baseline to 8 weeks
Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item scale assessing dispositional mindfulness (i.e., open or receptive awareness of and attention to what is taking place in the present). Higher scores reflect higher levels of dispositional mindfulness.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start7 May 2021
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
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 Spinal Cord InjuriesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- 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
- NCT04670406
- Sponsor's protocol ID
- IRB-300006536
- Status last verified
- Sep 2021
- First submitted
- 8 Dec 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han A, Wilroy JD, Jenkins J, Yuen HK. Effects of a coach-guided videoconferencing acceptance and commitment therapy intervention combined with psychoeducation on distressed individuals living with spinal cord injury: a preliminary mixed-methods study. Disabil Rehabil. 2023 Feb;45(4):644-654. doi: 10.1080/09638288.2022.2038283. Epub 2022 Feb 12.
PubMed 35156500
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guided Online Acceptance and Commitment Therapy (ACT) Intervention Combined With Psychoeducation for People With Spinal Cord Injury: A Preliminary Study
- ClinicalTrials.gov ID
- NCT04670406
- Acronym / sponsor ID
- IRB-300006536
- Conditions
- Spinal Cord Injuries, Psychological Distress
- Keywords
- Acceptance and Commitment Therapy, Quality of life, Spinal cord injury, Psychological distress, Depression, Anxiety, Stress, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 17 Dec 2020 (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.
The purpose of this preliminary study is to examine the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on people with spinal cord injury (SCI) who experience psychological distress.
Detailed description
This project will employ a one-group pretest-posttest design to investigate the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on quality of life and mental health of people with spinal cord injury (SCI) who experience psychological distress. After the pretest evaluation, eligible participants will receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and Spinal Cord Injury - Quality of Life (SCI-QOL). A one-time interview at the completion of the 8 sessions will be conducted to explore participants' experiences in the sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acceptance and commitment therapy (ACT) combined with psychoeducation | Experimental | Behavioral: acceptance and commitment therapy (ACT) combined with psychoeducationParticipants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- community-dwelling adults (age 18 or over) living in the community who had a spinal cord injury
- suffering at least mild symptoms of psychological distress measured by the DASS-21
- having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
- being able to provide informed consent by understanding the nature of study participation.
Key exclusion criteria (5 listed)
- having cognitive, physical, or sensory deficits, or language barriers (non- English communicator) that impede study participation
- receiving a psychological therapy currently
- having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
- taking antipsychotic or anticonvulsant medication at the time of recruitment
- having the possibility of study dropouts due to other medical conditions
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) combined with psychoeducationParticipants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. | Behavioural | acceptance and commitment therapy (ACT) combined with psychoeducation |
Primary outcome
Depression, Anxiety and Stress Scale (DASS) - 21
Time frame: Change from baseline to 8 weeks
The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.
World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component
Time frame: Change from baseline to 8 weeks
WHOQOL-BREF - psychological health component has 6 items measuring: bodily image and appearance; negative feelings; positive feelings; self-esteem; spirituality / personal beliefs; and thinking, learning, memory and concentration. Higher scores denote higher quality of life in terms of psychological health.
7 secondary outcomes
Self-Compassion Scale- Short Form (SCS-SF)
Time frame: Change from baseline to 8 weeks
Engagement in Meaningful Activities Survey (EMAS)
Time frame: Change from baseline to 8 weeks
Action and Acceptance Questionnaire (AAQ)-II
Time frame: Change from baseline to 8 weeks
Cognitive Fusion Questionnaire (CFQ)-7
Time frame: Change from baseline to 8 weeks
Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form
Time frame: Change from baseline to 8 weeks
Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form
Time frame: Change from baseline to 8 weeks
Mindful Attention Awareness Scale (MAAS)
Time frame: Change from baseline to 8 weeks
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 8 Sep 2021.
- Derived from this study: PubMed 35156500Han A, Wilroy JD, Jenkins J, Yuen HK. Effects of a coach-guided videoconferencing acceptance and commitment therapy intervention combined with psychoeducation on distressed individuals living with spinal cord injury: a preliminary mixed-methods study. Disabil Rehabil. 2023 Feb;45(4):644-654. doi: 10.1080/09638288.2022.2038283. Epub 2022 Feb 12.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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) combined with psychoeducation in people with Spinal Cord Injuries and Psychological Distress, 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 4 inclusion and 5 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 8 Sep 2021. 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?
Depression, Anxiety and Stress Scale (DASS) - 21 (time frame: Change from baseline to 8 weeks). The study lists 2 primary outcomes in all. 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 NCT04670406, 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 8 Sep 2021.