Clinical trial NCT06147258: The Impact of Expressive Emotional Writing on Facilitating Grief Resolution in Adults With Spinal Cord Injury
Official title: The Impact of Expressive Emotional Writing on Facilitating Grief Resolution in Adults With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Transverse Myelitis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the therapeutic benefits of a 10-week online coach-guided EEWP on psychosocial health among adults with SCI.

Detailed description: Paralysis in people with spinal cord injury (SCI) leads to grief from the loss of physical capacity, social or occupational role function, and life goals. Expressive emotional writing (EEW) provides an outlet for these individuals to explore and express feelings and emotions that arise from their losses related to limb paralysis. Using a randomized controlled trial design, the proposed project will attempt to confirm the benefits of an online coach-guided EEW program for improving psychosocial health among adults with SCI. Benefits of participating in the program will be evaluated using validated assessments to measure reduction of grief intensity and improvement in other psychosocial dimensions and social participation.

Eligibility criteria: Inclusion Criteria: (1) diagnosis (with evidence) of SCI (traumatic or non-traumatic) with limb weakness; (2) aged \> 18 years; (3) access to the internet and a computer or to a smartphone that can perform videoconferencing, (4) sufficient English language and cognitive proficiency to complete self-report study questionnaires and understand program content in English, and able to communicate verbally or through writing.

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Exclusion Criteria: (1) severe cognitive impairments that prevent online learning and completion of the evaluation; (2) suicidal intent requiring emergency care; (3) consistent psychotherapy within the last 6 months; (4) current or planned participation in psychological therapy or a clinical trial during the study period that could affect the outcomes of the study; or (5) congenital SCI (e.g., spinal bifida)

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Primary outcomes:
measure: Grief and Loss Scale
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Impact of Events Scale
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Emotional Distress - Depression
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Perceived Stress Scale (PSS)
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Sleep Disturbance
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Sleep Impact
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Meaning and Purpose
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Self-Efficacy for Managing Chronic Conditions - Managing Emotions
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Ability to Participate in Social Roles and Activities
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Satisfaction with Social Roles and Activities
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Connor-Davidson Resilience Scale
timeFrame: baseline, 11 weeks, 3-month follow-up
measure: Cortisol level
timeFrame: baseline, 11 weeks, 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Hon Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References: