NCT06618404

Brief Summary

Mental health decline after Spinal Cord Injury (SCI) is commonly reported but minimally investigated in the United Kingdom. The current study aims to explore the prevalence and impact of mental health challenges after SCI to establish population norms in the UK. Additionally the current study will aim to identify barriers to and facilitators of mental health support seeking in people with SCI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

August 17, 2021

Last Update Submit

September 30, 2024

Conditions

Keywords

ResilienceMental healthAdjustmentChronic pain

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    Generalised Anxiety Disorder Scale (GAD-7); minimum score = 0; maximum score = 21; Scores higher than 15 represent severe clinical levels of anxiety.

    Baseline

  • Depression

    Patient Health Questionnaire-9 (PHQ-9); minimum score = 0; maximum = 27; scores over 20 represent severe clinical depression.

    Baseline

  • Post-traumatic Stress Disorder

    Impact of Event Scale-Revised (IES-R); 22 item measure of PTSD; minimum score = 0; maximum score = 88; scores over 33 indicate the clinical cut-off for probable PTSD.

    Baseline

Secondary Outcomes (4)

  • Pain Interference

    Baseline

  • Coping Self-efficacy

    Baseline

  • Resilience

    Baseline

  • Life Satisfaction

    Baseline

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with spinal cord injury (Phases 1, 2 and 4) or their 'significant others' (Phase 3)

You may qualify if:

  • Adults with spinal cord injury
  • Adults with cauda equina syndrome

You may not qualify if:

  • Difficulty with written or verbal English Language comprehension
  • \- Partner, Spouse, Family member or carer of a person with Spinal Cord Injury
  • \- Difficulty with verbal English Language comprehension
  • \- Adults with Spinal Cord Injury who screen as having resilience higher than 30 on the Connor-Davidson Resilience Scale (CDRS-10).
  • Adults with Spinal Cord Injury with resilience lower than 30
  • Adults with Spinal Cord Injury who choose not to complete the CDRS-10.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 7BE, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord InjuriesAnxiety DisordersDepressionStress Disorders, Post-TraumaticPainPsychological Well-BeingChronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal Satisfaction

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Katherine Finlay, Lecturer in Psychology

Study Record Dates

First Submitted

August 17, 2021

First Posted

October 1, 2024

Study Start

May 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Anonymised data from the survey will be shared using https://odc-sci.org

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
From January 2022, indefinitely
Access Criteria
ODC-SCI membership
More information

Locations