The Impact of Expressive Emotional Writing on Facilitating Grief Resolution in Adults With Spinal Cord Injury

NCT06147258 | Recruiting

• 1 other identifier: 1925594-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Transverse Myelitis

Outcome Measures

Primary Outcomes (12)

• Grief and Loss Scale

  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.

  baseline, 11 weeks, 3-month follow-up

• Impact of Events Scale

  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.

  baseline, 11 weeks, 3-month follow-up

• Emotional Distress - Depression

  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)

  baseline, 11 weeks, 3-month follow-up

• Perceived Stress Scale (PSS)

  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.

  baseline, 11 weeks, 3-month follow-up

• Sleep Disturbance

  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 to 5=very much or 1=very good to 5=very poor. Two positively stated item require reversed coding. The scores range from 4 to 20. Higher scores reflect greater sleep problem.

  baseline, 11 weeks, 3-month follow-up

• Sleep Impact

  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: 5=never to 5=always. One positively stated item require reversed coding. The scores range from 5 to 25. Higher scores reflect less trouble falling asleep.

  baseline, 11 weeks, 3-month follow-up

• 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.

  baseline, 11 weeks, 3-month follow-up

• Self-Efficacy for Managing Chronic Conditions - Managing Emotions

  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.

  baseline, 11 weeks, 3-month follow-up

• Ability to Participate in Social Roles and Activities

  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.

  baseline, 11 weeks, 3-month follow-up

• Satisfaction with Social Roles and Activities

  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.

  baseline, 11 weeks, 3-month follow-up

• 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.

  baseline, 11 weeks, 3-month follow-up

• Cortisol level

  Hair cortisol level

  baseline, 11 weeks, 3-month follow-up

Study Arms (2)

Expressive writing

EXPERIMENTAL

Participation in a 10 weekly virtual expressive writing with 1 session per week

Behavioral: expressive writing

Waitlist control

NO INTERVENTION

Participation in usual daily activities

Interventions

expressive writing BEHAVIORAL

A typical session will begin with the teaching artist (i.e., writing coach) introducing a new writing theme. Participants will have at least 20 minutes to write, and each session will include post-writing reflections and sharing, an undirected supportive interaction among participants.

Expressive writing

Eligibility Criteria

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Endowment for the Arts, United States: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Myelitis, Transverse

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hon Yuen, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Yuen, PhD

CONTACT

205-934-6301; yuen@uab.edu

Kimberly K

CONTACT

205-934-0862; kkirklin@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are masked to participant group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: May 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)