AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis

NCT04721717 | Recruiting

• 1 other identifier: IRB- 300005546
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Multiple Sclerosis; Transverse Myelitis; Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (11)

• 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.

  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)

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  11 weeks

Secondary Outcomes (4)

• Cortisol level

  11 weeks

• Quality of Life During Serious Illness - Family Carers

  11 weeks

• Hospital Anxiety and Depression Scale (HADS)

  11 weeks

• Caregiver Burden Inventory

  11 weeks

Study Arms (1)

People with SCI

People with paraplegia and quadriplegia People with multiple sclerosis People with transverse myelitis Caregivers of people with amyotrophic lateral sclerosis (ALS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sex: both Race/Ethnicity: all Age: aged 18 years or above Health status: Healthy

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

354 School of Health Professions Building

Birmingham, Alabama, 35294, United States

RECRUITING

Related Publications (1)

• Yuen 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.

  PMID: 37682297 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

hair sample for cortical analysis

MeSH Terms

Conditions

Spinal Cord Injuries; Multiple Sclerosis; Myelitis, Transverse; Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuroinflammatory Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Occupational Therapy

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 25, 2021
• Study Start: September 1, 2020
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)