Psychotic DisordersCRISPNCT04180709
CBT to Reduce Insomnia and Improve Social Recovery in Early Psychosis
A study testing Sleepio in people with Psychotic Disorders and Psychosis, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Psychosis, Sleep
- What is being tested?
- Sleepio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2020to 31 Jul 2023
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cameo Early Intervention
Cambridge, Cambridgeshire, CB4 1PX
About this study
Official title: Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)
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.
Read the 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).
- Conditions
- Psychotic Disorders, Psychosis, Sleep
- Being tested
- Sleepio
- Keywords
- Cognition, Social Recovery, Immunopsychiatry, Daily function, Sleep disturbances, Insomnia
- Medical subject headings
- Psychotic Disorders, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepioDevice
Sleepio is an online cognitive behavioural therapy (CBT) based intervention designed to treat insomnia, conducted is 6 sessions. The program is an automated media-rich web-based application that is driven dynamically by baseline, adherence, performance and progress data. At the beginning of each session The Prof conducts a progressive review with the participant exploring the diary data submitted the week prior that includes sleep status and pattern, as well as progress based on goals previously set by the participant. The information, support and advice are personally tailored based on underlying algorithms.
| Study group | Role | What they receive |
|---|---|---|
| Sleepio Intervention + Treatment As Usual (TAU) | Experimental | Participants will receive the online Sleepio intervention to be completed approximately once per week, at least 6 sessions during the 8-week period, and complete daily sleep diaries. In addition they will continue their treatment as usual (TAU) with the CAMEO Early Intervention in Psychosis CPFT or Early Intervention in Psychosis Services NSFT care team. Receives: Device: Sleepio |
| Treatment As Usual (TAU) alone | No intervention | Participants will continue their treatment as usual (TAU) with their Early Intervention in Psychosis care team. They will however be offered access to the Sleepio intervention during the follow-up period of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study
WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measured: Measure completed at baseline (start of week 1) and week 9.
Secondary outcomes (10)
Time Use Survey - Structured Hours (TUS-SH)
Social recovery will be measured using an adapted versions of the Time Use Survey (TUS) Structured Hours, which has been previously validated for use as a social recovery measure by Hodgekins, Fowler and colleagues, and utilised in the National EDEN study (Hodgekins et al. 2015; Hodgekins 2012; Fowler et al. 2009). This will be adapted to a reduced interview to include only those areas relevant to the social recovery measure, hence the Time Use Survey-Structured Hours (TUS-SH).
Measured: Measure completed in weeks 1, 5, 9, 13 and 17.
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a self-administered measure of depression, which scores all 9 of the DSM-IV criteria for depression. Scores range from 0-27, with 5-9 indicating minimal symptoms, 10-14 minor depression, 15-19 moderately severe major depression and ≥20 severe major depression.
Measured: Measure completed in weeks 1, 5, 9, 13 and 17.
Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test
iPad delivered cognitive test of sustained attention.
Measured: Measure completed in weeks 1, 5, 9, 13 and 17.
Paired Associates Learning (PAL) / CANTAB Cognitive Test
iPad delivered cognitive test of visual episodic memory.
Measured: Measure completed in weeks 1, 5, 9, 13 and 17.
Spatial Working Memory (SWM) / CANTAB Cognitive Test
iPad delivered cognitive test of working memory and strategy.
Measured: Measure completed in weeks 1, 5, 9, 13 and 17.
Emotion Recognition Task (ERT) / CANTAB Cognitive Test
iPad delivered cognitive test of emotional recognition.
Measured: Measure completed in weeks 1, 5, 9, 13 and 17.
Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S)
GAF is an assessment of psychological, social and occupational functioning along a hypothetical continuum of mental health/illness. It is suggested that symptom scale for degree of severity be considered to cover the past 3 days prior to assessment but time frames can be varied based on the intention of use (Aas 2011). However by utilising the split version of this measure, the symptom and function scores can be evaluated and considered independently. This has been shown to be highly consistent across experienced raters, so sufficient training and utilisation may be fundamental to its efficacy (Pedersen et al. 2007). Scores range from 0-100 with higher scores representing better functioning across symptomatic and functional domains (Hall 1995).
Measured: Measure completed in weeks 1, 9 and 17.
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17
WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measured: Measure completed at baseline (start of week 1) and week 17.
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis
WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measured: Measure completed at baseline (start of week 1) and week 5.
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis
WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
Measured: Measure completed at baseline (start of week 1) and week 13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start30 Oct 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge Cognition Ltd, Big Health Inc.
- Responsible party
- Principal investigator, Peter Jones, University of Cambridge
- Investigators
- Peter B Jones, PhD MD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180709
- Sponsor's protocol ID
- M00915
- Other IDs
- RNAG-521, 224101, 19/EE/0352
- Acronym
- CRISP
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2019
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)
- ClinicalTrials.gov ID
- NCT04180709
- Acronym / sponsor ID
- CRISP / M00915
- Conditions
- Psychotic Disorders, Psychosis, Sleep
- Keywords
- Cognition, Social Recovery, Immunopsychiatry, Daily function, Sleep disturbances, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge Cognition Ltd, Big Health Inc.
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 27 Nov 2019 (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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sleepio Intervention + Treatment As Usual (TAU) | Experimental | Device: SleepioParticipants will receive the online Sleepio intervention to be completed approximately once per week, at least 6 sessions during the 8-week period, and complete daily sleep diaries. In addition they will continue their treatment as usual (TAU) with the CAMEO Early Intervention in Psychosis CPFT or Early Intervention in Psychosis Services NSFT care team. |
| Treatment As Usual (TAU) alone | No intervention | –Participants will continue their treatment as usual (TAU) with their Early Intervention in Psychosis care team. They will however be offered access to the Sleepio intervention during the follow-up period of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| SleepioSleepio is an online cognitive behavioural therapy (CBT) based intervention designed to treat insomnia, conducted is 6 sessions. The program is an automated media-rich web-based application that is driven dynamically by baseline, adherence, performance and progress data. At the beginning of each session The Prof conducts a progressive review with the participant exploring the diary data submitted the week prior that includes sleep status and pattern, as well as progress based on goals previously set by the participant. The information, support and advice are personally tailored based on underlying algorithms. | Device | Sleepio Intervention + Treatment As Usual (TAU) |
Primary outcome
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study
Time frame: Measure completed at baseline (start of week 1) and week 9.
WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).
10 secondary outcomes
Time Use Survey - Structured Hours (TUS-SH)
Time frame: Measure completed in weeks 1, 5, 9, 13 and 17.
Patient Health Questionnaire (PHQ-9)
Time frame: Measure completed in weeks 1, 5, 9, 13 and 17.
Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test
Time frame: Measure completed in weeks 1, 5, 9, 13 and 17.
Paired Associates Learning (PAL) / CANTAB Cognitive Test
Time frame: Measure completed in weeks 1, 5, 9, 13 and 17.
Spatial Working Memory (SWM) / CANTAB Cognitive Test
Time frame: Measure completed in weeks 1, 5, 9, 13 and 17.
Emotion Recognition Task (ERT) / CANTAB Cognitive Test
Time frame: Measure completed in weeks 1, 5, 9, 13 and 17.
Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S)
Time frame: Measure completed in weeks 1, 9 and 17.
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17
Time frame: Measure completed at baseline (start of week 1) and week 17.
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis
Time frame: Measure completed at baseline (start of week 1) and week 5.
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis
Time frame: Measure completed at baseline (start of week 1) and week 13.
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 15 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Peter B Jones, PhD MD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleepio in people with Psychotic Disorders and Psychosis, run by University of Cambridge 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 8 inclusion and 7 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 15 Aug 2023. 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?
Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study (time frame: Measure completed at baseline (start of week 1) and week 9.). 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 15 Aug 2023.