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NCT Number: NCT06147258

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Hon K Yuen, PhD

CONTACT

Hon K Yuen, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

Primary outcomes

  1. Grief and Loss Scale

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  2. Impact of Events Scale

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  3. Emotional Distress - Depression

    Time frame: baseline, 11 weeks, 3-month follow-up

    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)

  4. Perceived Stress Scale (PSS)

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  5. Sleep Disturbance

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  6. Sleep Impact

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  7. Meaning and Purpose

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  8. Self-Efficacy for Managing Chronic Conditions - Managing Emotions

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  9. Ability to Participate in Social Roles and Activities

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  10. Satisfaction with Social Roles and Activities

    Time frame: baseline, 11 weeks, 3-month follow-up

    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. Connor-Davidson Resilience Scale

    Time frame: baseline, 11 weeks, 3-month follow-up

    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.

  12. Cortisol level

    Time frame: baseline, 11 weeks, 3-month follow-up

    Hair cortisol level

Study contacts

Contact information is provided by the study sponsor or research team.

Hon Yuen, PhD

CONTACT

[email protected]

205-934-6301

Kimberly K

CONTACT

[email protected]

205-934-0862

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Endowment for the Arts, United States

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2023
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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