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NCT Number: NCT06618404

UK Prevalence of Mental Health After SCI

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.

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Key information

Conditions

Spinal Cord Injuries Anxiety Disorders Behavior Behavioral Symptoms Central Nervous System Diseases Chronic Pain Depression Mental Disorders Nervous System Diseases Neurologic Manifestations PTSD Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms Spinal Cord Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Reading

Reading, Berkshire, RG6 7BE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

No intervention - cross-sectional cohort analysis

Other

Observational

Primary outcomes

  1. 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.

  2. Depression

    Time frame: Baseline

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

  3. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. Resilience

    Time frame: Baseline

    Connor-Davison Resilience Scale-10 (CD-RISC-10); minimum score = 0; maximum score = 100; higher scores indicate greater resilience.

  4. Life Satisfaction

    Time frame: Baseline

    Satisfaction with Life Scale (SWLS); minimum score = 5; maximum score = 35, with higher scores indicating greater satisfaction with life

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Spinal Injuries Association
  • University of Buckingham

Registry information

Official study title

Establishing the Mental Health Needs of People With Spinal Cord Injury

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

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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