UK Prevalence of Mental Health After SCI

September 30, 2024 updated by: Katherine Finlay, University of Reading

Establishing the Mental Health Needs of People With Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A four-phase mixed methods research study will be undertaken. Phase One will be a cross-sectional online survey designed to determine the prevalence of mental health conditions in adults with SCI in the UK assessing resilience, anxiety, depression, pain, life satisfaction, PTSD and coping self-efficacy.

Phase Two will consist of in-depth semi-structured online interviews conducted with approximately twenty people with Spinal Cord Injury who, in the first study, indicated either that the participants had accessed, or had wanted to access mental health services. The two-part interview schedule will be undertaken, covering: 1) core themes surrounding the causes of, changes in, and management of mental health after SCI; and 2) questions relating to participant hopes for and experiences of satisfaction with, access to and efficacy of mental health services, in the context of the mental health service providers which participants currently use or have attempted to access.

Phase Three will consist of in-depth semi-structured online interviews held with approximately twenty 'significant others' (partner/family/friend) of people with Spinal Cord Injury whose family member/partner/friend experience mental health problems. The interview schedule will cover two core themes surrounding: 1) perceptions of the causes and impact of mental health difficulties after SCI on 'significant others'; 2) their experiences of current mental health services provided for participants' partner/family/friend and perceived recommendations and hopes for better management of mental health in participants' family member/partner.

Phase Four will recruit twenty-five people with high resilience (>30 on the CD-RISC-10) to participate in an in-depth semi-structured online interview. This will review participants' thoughts and perceptions about resilience and how it is possible to maintain a high level of resilience whilst living with spinal cord injury.

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 7BE
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria: Phases 1 and 2 (survey and SCI interviews)

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

Exclusion Criteria:

  • Difficulty with written or verbal English Language comprehension

Inclusion Criteria: Phase 3

- Partner, Spouse, Family member or carer of a person with Spinal Cord Injury

Exclusion criteria:

- Difficulty with verbal English Language comprehension

Inclusion Criteria: Phase 4

- Adults with Spinal Cord Injury who screen as having resilience higher than 30 on the Connor-Davidson Resilience Scale (CDRS-10).

Exclusion Criteria: Phase 4

  • Adults with Spinal Cord Injury with resilience lower than 30
  • Adults with Spinal Cord Injury who choose not to complete the CDRS-10.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline
Generalised Anxiety Disorder Scale (GAD-7); minimum score = 0; maximum score = 21; Scores higher than 15 represent severe clinical levels of anxiety.
Baseline
Depression
Time Frame: Baseline
Patient Health Questionnaire-9 (PHQ-9); minimum score = 0; maximum = 27; scores over 20 represent severe clinical depression.
Baseline
Post-traumatic Stress Disorder
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Interference
Time Frame: Baseline
Multi-dimensional Pain Inventory: Spinal Cord Injury (MPI-SCI) Life Interference Subscale; Minimum interference score = 0; maximum interference score = 120; high scores indicate more problematic interference of pain with life.
Baseline
Coping Self-efficacy
Time Frame: Baseline
Coping Self-efficacy scale (CSES); minimum score = 0; maximum score = 50 (the mean for each of the five subscales is then summed).
Baseline
Resilience
Time Frame: Baseline
Connor-Davison Resilience Scale-10 (CD-RISC-10); minimum score = 0; maximum score = 100; higher scores indicate greater resilience.
Baseline
Life Satisfaction
Time Frame: Baseline
Satisfaction with Life Scale (SWLS); minimum score = 5; maximum score = 35, with higher scores indicating greater satisfaction with life
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

University of Buckingham
Spinal Injuries Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHSCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

From January 2022, indefinitely

IPD Sharing Access Criteria

ODC-SCI membership

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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