Clinical trial NCT04180709: CBT to Reduce Insomnia and Improve Social Recovery in Early Psychosis
Official title: Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Psychosis
Sleep
Keywords: Cognition
Social Recovery
Immunopsychiatry
Daily function
Sleep disturbances
Insomnia
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Cambridgeshire and Peterborough NHS Foundation Trust
name: Cambridge Cognition Ltd
name: Big Health Inc.
First posted: 2019-11-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised parallel study design, with five points of measurements. Participants will receive either the Sleepio online intervention + treatment as usual (TAU) or TAU alone over an 8-week period. A follow-up period will be conducted for an additional 8 weeks. The original TAU group will be offered the intervention during this period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery.

This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) or Early Intervention in Psychosis Services (EIS), in Norfolk and Suffolk NHS Foundation Trust (NSFT). Cameo CPFT and Early Intervention in Psychosis Services NSFT are services for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk and https://www.nsft.nhs.uk/adults/service/early-intervention-in-psychosis-services-norfolk-and-waveney-103/). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their early intervention team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.

Detailed description: The study will take place in three stages; an initial survey, an eight week study period and a follow-up period for an additional eight weeks.

Stage One: Perceptions of Sleep Problems and Their Treatment in Psychosis:

Clinicians and service users will receive an online link to a short 18-question survey (primarily multiple choice) that should take approximately 5 min to complete. Although they can complete this online, a paper copy can be provided if they prefer to handwrite their answers.

Stage Two: Randomised 8 Week Study:

At our initial phone or NHS approved video platform meeting participants will be invited to ask any questions they have. If they choose to participate in our study, they will be asked to read and sign a consent form virtually or through the post. They will also be asked their preferred method of contact during the study so that the primary researcher can arrange appointments and check in once or twice per week. This will allow them to ask any questions which may arise and offer assistance if they are having any challenges with logging in or participation. They will also be informed that they have the right to withdraw from the study at any point and this will have no affect on their ongoing treatment through the EIS they are currently supported by.

Following consent to take part in the research study participants will answer some screening questions and complete a short 8-question assessment (about 5-10 min). Participants will be asked general questions about themselves and with their consent some diagnostic information will be obtained from clinical records. Following this they will be randomly assigned to one of two groups. The first will utilise the Sleepio intervention during the 8-week study period, along with their usual treatment from the EIS team and the second group will just continue their usual treatment for this 8-week period.

Prior to starting the study period, we will ask participants to monitor their sleep for one week using a nightly sleep diary (2-3 minutes) and by asking them to wear an actigraphy watch, a small device that records movement, light and near body temperature. At the end of this week we will complete baseline assessments with all participants and provide them with access logins for Sleepio. Most of these can be completed online and should only take about 35 minutes. The Guided Web-Based CANTAB cognitive tests will take approximately 25 min, be done online with video support from the researcher, and will include breaks for participant comfort. They will also have the option of completing some or all of the self assessments over the phone, video call or by post if they prefer.

The researcher administered assessments will be done with Camice Revier, the lead researcher, and should take around 15 min.

During the 8-week intervention period participants will complete weekly online 20-30 minute interventions via Sleepio (6 interventions in total, as occasional delays are accommodated for and expected) and complete nightly sleep diaries online via Sleepio (2-3 minutes).

After 4-weeks of the study participants will be asked to do a second round of assessments. This round has fewer measures and should only take about 20 minutes for the online assessments, 25 minutes for the Guided CANTAB cognitive tests and around 10 minutes for those done over the phone or video meeting.

During week 7 of the study we'll ask participants to again wear the actigraphy watch for another week.

The third round of assessments will take place at the end of the 8-week study period and will be the same duration as the original assessments: online about 35 min, CANTAB cognitive tests about 25 min and over the phone or video meeting about 10 min.

Stage Three: Follow-up and Anonymous Feedback Questionnaire:

During the follow-up period we will invite those who were not randomised into the treatment group to utilise the Sleepio intervention at this time.

All of the assessments will take place in the same order and duration as they did during the initial study period.

During week 7 of the follow-up period we'll ask participants, one final time, to complete the sleep diaries and wear the actigraphy watch for a final week.

Following the study participants will be invited to complete an anonymous feedback questionnaire. This is intended to provide a way for them to communicate any input or suggestions based on their experience and to help us improve the way we do things.

They will be offered the option of researchers contacting them for additional follow-up or to be invited to participate in related studies. There is no obligation for them to do so and they can indicate on their consent form whether they are willing to be contacted at a later date (within 5 years).

Eligibility criteria: Inclusion Criteria:

* Experiencing or having experienced a First Episode of Psychosis (FEP) within the past 5 years.
* Currently participating in CPFT CAMEO EIPS or NSFT EIS and intending to continue TAU with the specified service for at least the next 4 months.
* Mental capacity for consent.
* Currently experiencing threshold level (score ≤ 16 on SCI-8) of disrupted sleep.
* Adults 18 years or older.
* Ability to understand and follow therapeutic instructions necessary for experiment and respond to online questionnaires.
* Illness duration less than or equal to 5 years. Onset of illness was defined as first contact with psychiatric services for psychotic symptoms.
* Access to the internet.

Exclusion Criteria:

* Too unwell to viably participate in study.
* A diagnosis of drug induced psychosis or bipolar disorder.
* Psychotic disorder due to a medical or physical disease (i.e. considered to have an organic basis).
* Current drug or alcohol dependency.
* Currently taking prescribed sleep medication or intending to do so during study.
* Currently doing night shift work.
* Travel over 2 time zones during or within two weeks prior to assessment period.

Primary outcomes:
measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study
timeFrame: Measure completed at baseline (start of week 1) and week 9.
Secondary outcomes:
measure: Time Use Survey - Structured Hours (TUS-SH)
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
measure: Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
measure: Paired Associates Learning (PAL) / CANTAB Cognitive Test
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
measure: Spatial Working Memory (SWM) / CANTAB Cognitive Test
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
measure: Emotion Recognition Task (ERT) / CANTAB Cognitive Test
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
measure: Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S)
timeFrame: Measure completed in weeks 1, 9 and 17.
measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17
timeFrame: Measure completed at baseline (start of week 1) and week 17.
measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis
timeFrame: Measure completed at baseline (start of week 1) and week 5.
measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis
timeFrame: Measure completed at baseline (start of week 1) and week 13.
Other outcomes:
measure: Sleep Condition Indicator (SCI-8)
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
measure: Insomnia Severity Index (ISI)
timeFrame: Measure completed in weeks 1, 9 and 17.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Measure completed in weeks 1, 9 and 17.
measure: Validation of Sleep Diaries by comparison with actigraphy activity data
timeFrame: Monitoring will be done for a complete week just prior to week 1, during week 8 and 16. Sleep diaries are collected nightly during this same period.
measure: COVID-19 Brief Questionnaire (COVID-19-B)
timeFrame: Measure completed in weeks 1, 5, 9, 13 and 17.
Locations:
city: Cambridge
country: United Kingdom
facility: Cameo Early Intervention
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: Peter B Jones, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: