Clinical trial NCT04721717: AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
Official title: AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Multiple Sclerosis
Transverse Myelitis
Amyotrophic Lateral Sclerosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sex: both Race/Ethnicity: all Age: aged 18 years or above Health status: Healthy

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older with paralysis living in the community
2. 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
3. a non-traumatic spinal cord injury may be caused by arthritis, cancer, inflammation, infections or disk degeneration of the spine
4. caregivers of people with amyotrophic lateral sclerosis
5. able to communicate verbally or through writing

Exclusion Criteria:

1. known maladaptive behavioral patterns, exhibition of overt psychotic symptoms (e.g., presence of hallucinations, delusions, or thought disorders)
2. congenital (e.g., spinal bifida, cerebral palsy)

Primary outcomes:
measure: The Grief and Loss Scale
timeFrame: 11 Weeks
measure: Emotional Distress - Depression
timeFrame: 11 Weeks
measure: Perceived Stress Scale
timeFrame: 11 Weeks
measure: Impact of Events Scale
timeFrame: 11 Weeks
measure: Meaning and Purpose
timeFrame: 11 Weeks
measure: Self-Efficacy for Managing Chronic Conditions - Managing Emotions
timeFrame: 11 Weeks
measure: Sleep Disturbance
timeFrame: 11 Weeks
measure: Sleep Impact
timeFrame: 11 Weeks
measure: Ability to Participate in Social Roles and Activities
timeFrame: 11 Weeks
measure: Satisfaction with Social Roles and Activities
timeFrame: 11 Weeks
measure: Connor-Davidson Resilience Scale
timeFrame: 11 weeks
Secondary outcomes:
measure: Cortisol level
timeFrame: 11 weeks
measure: Quality of Life During Serious Illness - Family Carers
timeFrame: 11 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 11 weeks
measure: Caregiver Burden Inventory
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 354 School of Health Professions Building
state: Alabama
Study officials:
References: