AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 population
Sex: both Race/Ethnicity: all Age: aged 18 years or above Health status: Healthy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 1 trial groupGroup A: People with SCI
Trial outcomes
Primary outcomes
1
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.
Time frame
11 Weeks2
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)
Time frame
11 Weeks3
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.
Time frame
11 Weeks4
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.
Time frame
11 WeeksSecondary outcomes
1
Cortisol level
Hair cortisol level
Time frame
11 weeks2
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.
Time frame
11 weeks3
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.
Time frame
11 weeks4
Caregiver Burden Inventory
It has 24 items rated on a 5-point scale with higher scores indicating higher frequent of experiencing caregiver burden.
Time frame
11 weeksSponsors and contacts
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Source ClinicalTrials.gov