Clinical trial NCT06618404: UK Prevalence of Mental Health After SCI
Official title: Establishing the Mental Health Needs of People With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Anxiety Disorders
Depression
PTSD
Pain
Keywords: Resilience
Mental health
Adjustment
Chronic pain
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Spinal Injuries Association
name: University of Buckingham
First posted: 2024-10-01
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with spinal cord injury (Phases 1, 2 and 4) or their 'significant others' (Phase 3)

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Post-traumatic Stress Disorder
timeFrame: Baseline
Secondary outcomes:
measure: Pain Interference
timeFrame: Baseline
measure: Coping Self-efficacy
timeFrame: Baseline
measure: Resilience
timeFrame: Baseline
measure: Life Satisfaction
timeFrame: Baseline
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References: