Spinal Cord InjuriesNCT04721717
AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
An observational study of Spinal Cord Injuries and Multiple Sclerosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Multiple Sclerosis, Transverse Myelitis
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 4 Apr 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sex: both Race/Ethnicity: all Age: aged 18 years or above Health status: Healthy
Who may be able to join
- Age 18 or older with paralysis living in the community
- limb paralysis resulting from a traumatic event/accident or neurological disease (e.g., spinal cord injury, head injury, stroke, multiple sclerosis, Transverse myelitis, poliomyelitis, peripheral neuropathy, Parkinson's disease, ALS, botulism, and Guillain-Barré syndrome etc) happened after childhood
- a non-traumatic spinal cord injury may be caused by arthritis, cancer, inflammation, infections or disk degeneration of the spine
- caregivers of people with amyotrophic lateral sclerosis
- able to communicate verbally or through writing
Who cannot join
- known maladaptive behavioral patterns, exhibition of overt psychotic symptoms (e.g., presence of hallucinations, delusions, or thought disorders)
- congenital (e.g., spinal bifida, cerebral palsy)
Trial locations and contacts
1 site in 1 country.
United States1 site
354 School of Health Professions Building
Birmingham, Alabama, 35294
About this study
The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury.
Read the detailed description
Because of the inability to move certain parts of the body, persons with paralysis caused by neurological conditions such as spinal cord injury, traumatic head injury, and stroke experience grief from the loss of physical capacity, social or occupational role function, and life goals. Common complications associated with grief in these individuals include increased anxiety and depression, poor physical health, and low sense of purpose in life. Therefore, it is essential to identify community-based, self-help support that can serve as a step to facilitate healthy grieving in these individuals. Such support should aim at shifting their mindset from focusing on their loss (disability) to restoring daily function. Constructing and reconstructing the story of one's own life has been reported in several autobiographic accounts as a coping strategy to learn acceptance and how to live with various traumatic conditions (i.e., grief resolution).
Writing about emotionally traumatic or challenging experiences has been shown to have a surprisingly beneficial effect on reports of symptom reduction and health care use, as well as improvements in health status and well-being in people with chronic conditions. Expressive emotional writing programs have demonstrated the ability to improve the quality of life of individuals with chronic conditions. Although expressive writing could be a promising avenue in reducing grief and improving psychosocial and physical functioning among adults with paralysis, currently, few programs on expressive emotional writing are available for these individuals. Therefore, the UAB Institute for Arts in Medicine (AIM) will implement an innovative expressive emotional writing pilot project for adults with paralysis.
To maximize the number of adults with paralysis who can benefit from participating in this expressive emotional writing program, the investigators will partner with two additional organizations -the Is-Able Center and the Lakeshore Foundation in Birmingham, Alabama. The Is-Able Center (https://isable.org/) is a non-profit community organization which provides services including grief support that encourage, educate and empower the quality of life for individuals with disabilities. The Lakeshore Foundation (https://www.lakeshore.org/) is also a non-profit community organization that serves and advocates for people with physical disabilities.
The writing program will take place at both the Is-Able Center and Lakeshore Foundation starting in July 2020. The program will run for 10 consecutive weeks, with weekly writing activities. The grant funds will be used to reimburse mileage for adults with paralysis for participation in the writing program, hire a program coordinator, and two coaches to facilitate the writing program and facilitate discussion conducted in each of the two community organizations.
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Transverse Myelitis, Amyotrophic Lateral Sclerosis
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis, Myelitis, Transverse, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with SCI | People with paraplegia and quadriplegia People with multiple sclerosis People with transverse myelitis Caregivers of people with amyotrophic lateral sclerosis (ALS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Grief and Loss Scale
(Kalpakjian et al., 2015) is a 9-item measure of an individual's emotional reactions or grief such as anger, guilt, anxiety, sadness, and despair in the past 7 days, using a 5-point scale (1=never) to 5 (always). The scores range from 9 to 45. Higher scores reflect higher degree of grief and loss.
Measured: 11 Weeks
Emotional Distress - Depression
Short Form 8b. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is an 8-item measure of an individual's emotional distress (depression) in the past 7 days, using a 5-point scale (1=never) to 5 (always). The scores range from 8 to 40. Higher scores reflect higher degree of emotional distress (depression)
Measured: 11 Weeks
Perceived Stress Scale
PSS) (Cohen et al. 1988) is a 10-item measure of frequency of an individual experiencing stress in the past month, using a 5-point scale (1=never) to (5=very often). Four positively stated items require reversed coding. The scores range from 10 to 50. Higher scores reflect higher frequency of experiencing stress.
Measured: 11 Weeks
Impact of Events Scale
(Weiss, 2007). It is a 6-item measure of an individual's distress related to different difficulties in the past 7 days, using a 5-point scale (0=not at all) to 4 (extremely). The scores range from 0 to 24. Higher scores reflect greater distress.
Measured: 11 Weeks
Meaning and Purpose
It is part of the NIH Toolbox Item Bank. It is a 7-item measure of an individual's meaning and purpose in life, using a 5-point scale (1=strongly disagree) to 5 (strongly agree). The scores range from 7 to 35. Higher scores reflect greater meaning and purpose in life.
Measured: 11 Weeks
Self-Efficacy for Managing Chronic Conditions - Managing Emotions
Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's self-efficacy for managing chronic conditions, using a 5-point scale (1=I am not at all confident) to 5 (I am very confident). The scores range from 4 to 20. Higher scores reflect greater confident in managing chronic conditions.
Measured: 11 Weeks
Sleep Disturbance
Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's sleep problem or quality in the past 7 days, using a 5-point scale (1=not at all/very much) to 5 (very much/very poor). Two positively stated item require reversed coding. The scores range from 4 to 20. Higher scores reflect greater sleep problem.
Measured: 11 Weeks
Sleep Impact
Short Form. It is a part of the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ). It is a 5-item measure of an individual's trouble falling asleep in the past 7 days, using a 5-point scale (1=always) to 5 (never). One positively stated item require reversed coding. The scores range from 5 to 25. Higher scores reflect less trouble falling asleep.
Measured: 11 Weeks
Ability to Participate in Social Roles and Activities
Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's trouble participating in social roles and activities, using a 5-point scale (1=always) to 5 (never). The scores range from 4 to 20. Higher scores reflect less trouble participating in social roles and activities.
Measured: 11 Weeks
Satisfaction with Social Roles and Activities
It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's satisfaction with social roles and activities, using a 5-point scale (1=not at all) to 5 (very much). The scores range from 4 to 20. Higher scores reflect greater satisfaction with social roles and activities.
Measured: 11 Weeks
Connor-Davidson Resilience Scale
It consists of 10 statements that respondents rated on a 5-point scale from 0 - Not true at all.
1 - Rarely true.2 - Sometimes true.3 - Often true.4 - True nearly all the time. Answers were scored from 0 to 4 to create a total score that ranged from 0 to 100, with higher numbers denoting greater resilience.
Measured: 11 weeks
Secondary outcomes (4)
Cortisol level
Hair cortisol level
Measured: 11 weeks
Quality of Life During Serious Illness - Family Carers
It consists of 16 statements that family carers rated on a 11-point scale from 0 - 10 that best represents how they feel. Some items require reversed coding. Higher scores denote better quality of life.
Measured: 11 weeks
Hospital Anxiety and Depression Scale (HADS)
It has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring.
Measured: 11 weeks
Caregiver Burden Inventory
It has 24 items rated on a 5-point scale with higher scores indicating higher frequent of experiencing caregiver burden.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Sep 2020
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation, The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Hon K. Yuen, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721717
- Sponsor's protocol ID
- IRB- 300005546
- Other IDs
- 2027598; and 967751
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie SM, McKenna M, Veach K, Williams S, Jones MG, Vander Kamp E, Green S, Edwards L, Kirklin K, Jones BA, Yuen HK. Assessing the Psychosocial Impact of Expressive Writing on Adults With Spinal Cord Injury: Qualitative Study. JMIR Form Res. 2025 Jun 30;9:e71162. doi: 10.2196/71162.
PubMed 40587781Yuen HK, Kamp EV, Green S, Edwards L, Kirklin K, Hanebrink S, Klebine P, Han A, Chen Y. Effects of a coach-guided video-conferencing expressive writing program on facilitating grief resolution in adults with SCI. J Spinal Cord Med. 2024 Nov;47(6):1016-1025. doi: 10.1080/10790268.2023.2253390. Epub 2023 Sep 8.
PubMed 37682297
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
- ClinicalTrials.gov ID
- NCT04721717
- Acronym / sponsor ID
- IRB- 300005546
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Transverse Myelitis, Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation, The Craig H. Neilsen Foundation
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 25 Jan 2021 (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 UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury.
Detailed description
Because of the inability to move certain parts of the body, persons with paralysis caused by neurological conditions such as spinal cord injury, traumatic head injury, and stroke experience grief from the loss of physical capacity, social or occupational role function, and life goals. Common complications associated with grief in these individuals include increased anxiety and depression, poor physical health, and low sense of purpose in life. Therefore, it is essential to identify community-based, self-help support that can serve as a step to facilitate healthy grieving in these individuals. Such support should aim at shifting their mindset from focusing on their loss (disability) to restoring daily function. Constructing and reconstructing the story of one's own life has been reported in several autobiographic accounts as a coping strategy to learn acceptance and how to live with various traumatic conditions (i.e., grief resolution).
Writing about emotionally traumatic or challenging experiences has been shown to have a surprisingly beneficial effect on reports of symptom reduction and health care use, as well as improvements in health status and well-being in people with chronic conditions. Expressive emotional writing programs have demonstrated the ability to improve the quality of life of individuals with chronic conditions. Although expressive writing could be a promising avenue in reducing grief and improving psychosocial and physical functioning among adults with paralysis, currently, few programs on expressive emotional writing are available for these individuals. Therefore, the UAB Institute for Arts in Medicine (AIM) will implement an innovative expressive emotional writing pilot project for adults with paralysis.
To maximize the number of adults with paralysis who can benefit from participating in this expressive emotional writing program, the investigators will partner with two additional organizations -the Is-Able Center and the Lakeshore Foundation in Birmingham, Alabama. The Is-Able Center (https://isable.org/) is a non-profit community organization which provides services including grief support that encourage, educate and empower the quality of life for individuals with disabilities. The Lakeshore Foundation (https://www.lakeshore.org/) is also a non-profit community organization that serves and advocates for people with physical disabilities.
The writing program will take place at both the Is-Able Center and Lakeshore Foundation starting in July 2020. The program will run for 10 consecutive weeks, with weekly writing activities. The grant funds will be used to reimburse mileage for adults with paralysis for participation in the writing program, hire a program coordinator, and two coaches to facilitate the writing program and facilitate discussion conducted in each of the two community organizations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with SCI | – | –People with paraplegia and quadriplegia People with multiple sclerosis People with transverse myelitis Caregivers of people with amyotrophic lateral sclerosis (ALS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sex: both Race/Ethnicity: all Age: aged 18 years or above Health status: Healthy
Key inclusion criteria (5 listed)
- Age 18 or older with paralysis living in the community
- limb paralysis resulting from a traumatic event/accident or neurological disease (e.g., spinal cord injury, head injury, stroke, multiple sclerosis, Transverse myelitis, poliomyelitis, peripheral neuropathy, Parkinson's disease, ALS, botulism, and Guillain-Barré syndrome etc) happened after childhood
- a non-traumatic spinal cord injury may be caused by arthritis, cancer, inflammation, infections or disk degeneration of the spine
- caregivers of people with amyotrophic lateral sclerosis
- able to communicate verbally or through writing
Key exclusion criteria (2 listed)
- known maladaptive behavioral patterns, exhibition of overt psychotic symptoms (e.g., presence of hallucinations, delusions, or thought disorders)
- congenital (e.g., spinal bifida, cerebral palsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Grief and Loss Scale
Time frame: 11 Weeks
(Kalpakjian et al., 2015) is a 9-item measure of an individual's emotional reactions or grief such as anger, guilt, anxiety, sadness, and despair in the past 7 days, using a 5-point scale (1=never) to 5 (always). The scores range from 9 to 45. Higher scores reflect higher degree of grief and loss.
Emotional Distress - Depression
Time frame: 11 Weeks
Short Form 8b. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is an 8-item measure of an individual's emotional distress (depression) in the past 7 days, using a 5-point scale (1=never) to 5 (always). The scores range from 8 to 40. Higher scores reflect higher degree of emotional distress (depression)
Perceived Stress Scale
Time frame: 11 Weeks
PSS) (Cohen et al. 1988) is a 10-item measure of frequency of an individual experiencing stress in the past month, using a 5-point scale (1=never) to (5=very often). Four positively stated items require reversed coding. The scores range from 10 to 50. Higher scores reflect higher frequency of experiencing stress.
Impact of Events Scale
Time frame: 11 Weeks
(Weiss, 2007). It is a 6-item measure of an individual's distress related to different difficulties in the past 7 days, using a 5-point scale (0=not at all) to 4 (extremely). The scores range from 0 to 24. Higher scores reflect greater distress.
Meaning and Purpose
Time frame: 11 Weeks
It is part of the NIH Toolbox Item Bank. It is a 7-item measure of an individual's meaning and purpose in life, using a 5-point scale (1=strongly disagree) to 5 (strongly agree). The scores range from 7 to 35. Higher scores reflect greater meaning and purpose in life.
Self-Efficacy for Managing Chronic Conditions - Managing Emotions
Time frame: 11 Weeks
Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's self-efficacy for managing chronic conditions, using a 5-point scale (1=I am not at all confident) to 5 (I am very confident). The scores range from 4 to 20. Higher scores reflect greater confident in managing chronic conditions.
Sleep Disturbance
Time frame: 11 Weeks
Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's sleep problem or quality in the past 7 days, using a 5-point scale (1=not at all/very much) to 5 (very much/very poor). Two positively stated item require reversed coding. The scores range from 4 to 20. Higher scores reflect greater sleep problem.
Sleep Impact
Time frame: 11 Weeks
Short Form. It is a part of the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ). It is a 5-item measure of an individual's trouble falling asleep in the past 7 days, using a 5-point scale (1=always) to 5 (never). One positively stated item require reversed coding. The scores range from 5 to 25. Higher scores reflect less trouble falling asleep.
Ability to Participate in Social Roles and Activities
Time frame: 11 Weeks
Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's trouble participating in social roles and activities, using a 5-point scale (1=always) to 5 (never). The scores range from 4 to 20. Higher scores reflect less trouble participating in social roles and activities.
Satisfaction with Social Roles and Activities
Time frame: 11 Weeks
It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's satisfaction with social roles and activities, using a 5-point scale (1=not at all) to 5 (very much). The scores range from 4 to 20. Higher scores reflect greater satisfaction with social roles and activities.
Connor-Davidson Resilience Scale
Time frame: 11 weeks
It consists of 10 statements that respondents rated on a 5-point scale from 0 - Not true at all. 1 - Rarely true.2 - Sometimes true.3 - Often true.4 - True nearly all the time. Answers were scored from 0 to 4 to create a total score that ranged from 0 to 100, with higher numbers denoting greater resilience.
4 secondary outcomes
Cortisol level
Time frame: 11 weeks
Quality of Life During Serious Illness - Family Carers
Time frame: 11 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 11 weeks
Caregiver Burden Inventory
Time frame: 11 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 25 Sep 2026.
- Derived from this study: PubMed 40587781Xie SM, McKenna M, Veach K, Williams S, Jones MG, Vander Kamp E, Green S, Edwards L, Kirklin K, Jones BA, Yuen HK. Assessing the Psychosocial Impact of Expressive Writing on Adults With Spinal Cord Injury: Qualitative Study. JMIR Form Res. 2025 Jun 30;9:e71162. doi: 10.2196/71162.
- Derived from this study: PubMed 37682297Yuen HK, Kamp EV, Green S, Edwards L, Kirklin K, Hanebrink S, Klebine P, Han A, Chen Y. Effects of a coach-guided video-conferencing expressive writing program on facilitating grief resolution in adults with SCI. J Spinal Cord Med. 2024 Nov;47(6):1016-1025. doi: 10.1080/10790268.2023.2253390. Epub 2023 Sep 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Multiple Sclerosis, 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 5 inclusion and 2 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 Sep 2026. 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?
The Grief and Loss Scale (time frame: 11 Weeks). The study lists 11 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 NCT04721717, which also lists 2 linked publications.
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 Sep 2026.