ight-dark and activity rhythm therapy for sleep: a study to explore the practicality of delivering the therapy, and participant's experiences and views of whether the intervention is acceptable, in people with schizophrenia spectrum disorders
- Conditions
- Sleep problems in people with schizophrenia spectrum disordersMental and Behavioural DisordersSchizophrenia
- Registration Number
- ISRCTN11998005
- Lead Sponsor
- niversity of Manchester
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38131747/ (added 27/12/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 347
1. Diagnosis of non-affective psychosis: Schizophrenia, Schizotypal disorder, Delusional disorder, Schizoaffective disorder (ICD-10 F20, F21, F22, F25, F28 / DSM 295.*, 297.1)
2. Open to secondary care mental health services in Greater Manchester Mental Health and NHS Foundation Trust (GMMH) or Pennine Care NHS Foundation Trust (Pennine Care)
3. Aged over 18 years
4. Expresses dissatisfaction with their sleep (length of time to fall asleep, amount of sleep, subjective sleep quality, broken sleep, unrefreshing sleep, difficulty waking up, unsatisfactory timing of sleep)
5. Interested in receiving the intervention
Staff survey sub-study sample:
The person is a member of staff, a student, or a volunteer at GMMH or Pennine Care, or at a third sector service and working with service users of GMMH or Pennine Care (the person is a potential referrer or potential future referrer)
(added 05/01/2021) Anonymous service user survey sub-study:
The person is a service user at GMMH or Pennine Care, or at a third sector service and working with service users of GMMH or Pennine Care (the person is a service user or potential service user of GMMH or Pennine). No specific diagnosis inclusion criteria
1.1. Change of medication within the last 1 month
1.1. Discharged from hospital within the last 1 month
1.3. Current inpatient or acuity of illness requiring home treatment team
1.4. Actively suicidal (expressing suicidal plans or intent)
1.5. Risk to others prevents lone visiting
2.1. Known untreated significant sleep apnoea (AHI Index >20, or symptomatic)
2.2. Primary complaint is of sleep apnoea, sleep related movement disorder or parasomnia
2.3. Diagnosis of narcolepsy or REM sleep behaviour disorder
3. Co-morbid learning disability, dementia, or moderate to severe neurological impairment
4. Alcohol or substance dependent (unsuitable if using heavily every day and/or not able to be sober for sessions).
5. No fixed abode
6. Does not have capacity to give informed consent
There are no exclusion criteria for the staff survey
(added 05/01/2021) There are no exclusion criteria for the anonymous service user survey, but staff recruiting will be advised not to ask anyone who would find completing a brief survey confusing or distressing (although no sensitive topics are covered)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acceptability, adherence and feasibility of delivery based on data triangulated from the following sources:<br>1. Qualitative interview data (pre and post intervention)<br>2. Satisfaction Likert ratings (weekly throughout intervention)<br>3. Therapy adherence (completion of homework tasks, adherence to light and activity recommendations goals and agreements) (completed by therapist throughout)<br>4. Therapy delivery fidelity log (completed by therapist after sessions)<br>5. Attendance logs (% attendance) (completed by therapist after sessions)<br>6. Recruitment rates (% of those eligible and approached who consent, total number recruited by end of study)<br>7. Reasons for declining participation<br>8. Attrition (% of participants who consent to participate that remain in the study until the end of therapy, and until the end of follow up)<br>9. Reasons for attrition (e.g. therapy-related, study measure related, other reasons, no reason given)
- Secondary Outcome Measures
Name Time Method 1. Sleep disturbance measured by Insomnia Severity Index (ISI) & PROMIS-SD 8a (Sleep Disturbance)<br>2. Sleep-related impairment of functioning measured by PROMIS-SRI 8a (Sleep-Related Impairment)<br>3. Wellbeing and quality of life measured by Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS) & EQ 5D-5L (5-level EQ-5D version, EuroQol)<br>4. Social and occupational functioning measured by PROMIS-AP 8a (Ability to Participate in social roles and activities)<br>5. Psychiatric symptoms measured by Clinical Global Impression-Schizophrenia (CGI-SCH)<br><br>The above will be measured at week 1 (pre-intervention), week 17 (post intervention), and week 29 (follow up). PROMIS-SD 8a will also be used each week during therapy to track change over time.