Spinal Cord InjuriesNCT06618404
UK Prevalence of Mental Health After SCI
An observational study of Spinal Cord Injuries and Anxiety Disorders, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Anxiety Disorders, Depression
- How many people
- 318 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with spinal cord injury (Phases 1, 2 and 4) or their 'significant others' (Phase 3)
Who may be able to join
- Partner, Spouse, Family member or carer of a person with Spinal Cord Injury
- Adults with Spinal Cord Injury who screen as having resilience higher than 30 on the Connor-Davidson Resilience Scale (CDRS-10).
Who cannot join
- Difficulty with written or verbal English Language comprehension
- Difficulty with verbal English Language comprehension
- Adults with Spinal Cord Injury with resilience lower than 30
- Adults with Spinal Cord Injury who choose not to complete the CDRS-10.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Anxiety Disorders, Depression, PTSD, Pain
- Being tested
- No intervention - cross-sectional cohort analysis
- Keywords
- Resilience, Mental health, Adjustment, Chronic pain
- Medical subject headings
- Spinal Cord Injuries, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Pain, Psychological Well-Being, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - cross-sectional cohort analysisOther
Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Generalised Anxiety Disorder Scale (GAD-7); minimum score = 0; maximum score = 21; Scores higher than 15 represent severe clinical levels of anxiety.
Measured: Baseline
Depression
Patient Health Questionnaire-9 (PHQ-9); minimum score = 0; maximum = 27; scores over 20 represent severe clinical depression.
Measured: 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.
Measured: Baseline
Secondary outcomes (4)
Pain Interference
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.
Measured: Baseline
Coping Self-efficacy
Coping Self-efficacy scale (CSES); minimum score = 0; maximum score = 50 (the mean for each of the five subscales is then summed).
Measured: Baseline
Resilience
Connor-Davison Resilience Scale-10 (CD-RISC-10); minimum score = 0; maximum score = 100; higher scores indicate greater resilience.
Measured: Baseline
Life Satisfaction
Satisfaction with Life Scale (SWLS); minimum score = 5; maximum score = 35, with higher scores indicating greater satisfaction with life
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 May 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Spinal Injuries Association, University of Buckingham
- Responsible party
- Principal investigator, Katherine Finlay, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618404
- Sponsor's protocol ID
- MHSCI
- Status last verified
- Sep 2024
- First submitted
- 17 Aug 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data from the survey will be shared using https://odc-sci.org
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Mental Health Needs of People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06618404
- Acronym / sponsor ID
- MHSCI
- Conditions
- Spinal Cord Injuries, Anxiety Disorders, Depression, PTSD, Pain
- Keywords
- Resilience, Mental health, Adjustment, Chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Spinal Injuries Association, University of Buckingham
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with spinal cord injury (Phases 1, 2 and 4) or their 'significant others' (Phase 3)
Key inclusion criteria (2 listed)
- Partner, Spouse, Family member or carer of a person with Spinal Cord Injury
- Adults with Spinal Cord Injury who screen as having resilience higher than 30 on the Connor-Davidson Resilience Scale (CDRS-10).
Key exclusion criteria (4 listed)
- Difficulty with written or verbal English Language comprehension
- Difficulty with verbal English Language comprehension
- Adults with Spinal Cord Injury with resilience lower than 30
- Adults with Spinal Cord Injury who choose not to complete the CDRS-10.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - cross-sectional cohort analysisObservational | Other | – |
Primary outcome
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.
Depression
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9); minimum score = 0; maximum = 27; scores over 20 represent severe clinical depression.
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.
4 secondary outcomes
Pain Interference
Time frame: Baseline
Coping Self-efficacy
Time frame: Baseline
Resilience
Time frame: Baseline
Life Satisfaction
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. Anonymised data from the survey will be shared using https://odc-sci.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Anxiety Disorders, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.