Spinal Cord Injuries Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. - 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) - |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Cortisol level | Hair cortisol level | baseline, 11 weeks, 3-month follow-up |
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