Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)

Study Overview
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Brief Summary
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Insomnia occurs frequently causing a substantial burden to society (1). Historically, insomnia has been considered as secondary to a handful of other psychiatric disorders, such as depression and anxiety - but it is now clear that this disorder is associated with a wide range of psychiatric conditions and may actually precede and predict their development and severity (e.g. 2). Treating insomnia has been posited to hold the promise of reducing or preventing the development of co-morbid problems - although this possibility needs to be rigorously tested. Cognitive behavioural therapy (CBT) is an effective treatment for disturbed sleep, specifically insomnia, in adults (3) and is recommended by NICE for the management of long-term sleep problems. This treatment is more accessible than ever before given recent ground-breaking internet initiatives - such as the Sleepio programme (see: https://www.sleepio.com/home/), which was developed by one of the collaborators (Colin Espie) and has yielded encouraging results (4). Despite the importance of CBT for treating disturbed sleep and the finding that it leads to a good outcome for the majority of sufferers, some people fail to respond to this treatment. For example, research cited on the Sleepio website notes that around 70% of those with even very long term sleep difficulties experience long-term improvements from the treatment, meaning that 30% do not (see 4). Understanding more about who does and does not respond holds the promise of improving or tailoring treatments for insomnia. The study proposed here builds on recent work by one of the researchers who has been exploring demographic (5), clinical (e.g. 6) and most uniquely genetic (e.g. 7); and epigenetic (e.g. 8) predictors of psychological treatment response (coining the term Therapygenetics, see, 7). While these predictors are individually only likely to explain a small proportion of the variance of treatment outcome, understanding these multiple risks and their interaction is the best way to consider this issue. The study addressed here is a pilot study, necessary to demonstrate feasibility of utilising a sleep intervention application in an unselected sample of young adults, prior to applying for grant funding to undertake a larger but similar behavioural genetics study in the future. The main aim of this pilot study is to test the feasibility of the study design, by investigating whether unselected participants show an improvement in sleep quality after taking the intervention. Participation and drop out rates as well acceptability of the intervention in a non-clinical population will also be investigated. Research Questions: Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample? How feasible is it to run this study on a non-clinical sample? This will include investigating response rate, participant drop-out, and treatment accessibility. The investigators will also offer perform preliminary investigations into: Does improving sleep quality have implications for associated phenotypes? Specifically the investigators will examine symptoms of anxiety, depression, attention-deficit hyperactivity disorder (ADHD), psychosis, and well-being. Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome for sleep problems? Research questions 3) and 4) will be primary aims in the main study, but will constitute secondary aims in the pilot study as there won't be the statistical power to fully address these questions.

Official Title
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Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)

Conditions
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Sleep Problem

Intervention / Treatment
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* Procedure: Online CBT for insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Female Aged 18 plus Psychology student (undergraduate or postgraduate) at one of three London universities involved in the study. Exclusion Male Under 18 Not a psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online CBT for insomnia<br>CBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail. CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4). | Procedure: Online CBT for insomnia<br>* See CBT arm description for information about the CBT intervention. More details can be found in source 4 in the reference list.<br>|
| No Intervention: Puzzles<br>Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Insomnia Symptoms Following Online CBT | Changes in insomnia symptoms as assessed by scores on the Sleep Condition Indicator (SCI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-32. A higher score indicates fewer insomnia symptoms. Therefore a positive change score (>0) indicates fewer insomnia symptoms at the end of the intervention compared to baseline. A negative score (<0) indicates more symptoms at the end of the itnervention compared to baseline. | Change from baseline to 3 weeks, 6 weeks, and 6 months | 
| Improvement in Sleep Quality Following Online CBT | Changes in sleep quality as assessed by scores on the Pittsburgh Sleep Quality Index (PSQI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-21. The change score reflects the change in symptoms at each assessment compared with baseline. Higher scores on the indicate worse sleep quality. Therefore for the change score, a positive value indicates worse sleep quality at the assessment time period compared to baseline. A negative value indicates better sleep quality at the assessment time period compared to baseline. | Change from baseline to 3 weeks, 6 weeks, and 6 months | 
| Treatment Acceptability Mid-intervention | Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. | 3 weeks | 
| Treatment Acceptability at the End of the Intervention | Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. | 6 weeks | 
| Change in Treatment Acceptability During the Intervention | Change in treatment acceptability across the CBT-I treatment will be assessed, through changes in the score on the Treatment Acceptability Scale. Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. Therefore a positive change score means an improvement in treatment acceptability, whereas a negative change score indicates a reduction in treatment acceptability. | Change from baseline to 3 weeks and 6 weeks | 
| Attrition Rate | Drop-out rate will be assessed as the percentage of those who consented to take part in the study who did not complete the study. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of Treatment Outcome - Anxiety | Anxiety as a predictor of response to treatment outcome, as measured using the Trait State Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline | Baseline | 
| Predictors of Treatment Outcome - Depression | Anxiety as a predictor of response to treatment outcome, as measured using the Mood and Feelings Questionnaire. The theoretical range is 0-26, and a higher score indicates more anxiety symptoms at baseline | Baseline | 
| Predictors of Treatment Outcome - Attentional Problems | Attentional problems as a predictor of response to treatment outcome, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems at baseline | Baseline | 
| Predictors of Treatment Outcome - Psychotic Experiences | Psychotic experiences as a predictor of response to treatment outcome, as measured using the Specific Psychotic Experiences Questionnaire. Subsacles measuring paranoia (theoretical range 0-25), hallucinations (theoretical range 0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score indicates more psychotic experiences at baseline | Baseline | 
| Predictors of Treatment Outcome - Positive Mental Health | Positive mental health as a predictor of response to treatment outcome, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health at baseline | Baseline | 
| Predictors of Treatment Outcome - Stress | Stress as a predictor of response to treatment outcome, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates more perceived stress at baseline | Baseline | 
| Predictors of Treatment Outcome - Threatening Life Events | Threatening life events as a predictor of response to treatment outcome, as measured using the List of Threatening Events. The theoretical range is 0-24, and a higher score indicates more exposure to threatening events in the 12 months preceeding baseline | Baseline | 
| Changes in Scores on Associated Phenotypes - Anxiety | Anxiety symptoms, measured using the State Trait Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline. | 3 weeks, 6 weeks | 
| Changes in Scores on Associated Phenotypes - Depression | Depression symptoms, as measured using the Trait State Anxiety Index. The theoretical range is 0-26, and a higher score indicates more depression symptoms. | 3 weeks, 6 weeks | 
| Changes in Scores on Associated Phenotypes - Attentional Problems | Attentional problems, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems. | 3 weeks, 6 weeks | 
| Changes in Scores on Associated Phenotypes - Psychotic Experiences | Psychotic experiences, as measured using the Specific Psychotic Experiences Questionnaire. Three subscales measuring paranoia (theoretical ragne 0-25), hallucinations (0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score equals more frequent experiences | 6 weeks | 
| Changes in Scores on Associated Phenotypes - Positive Mental Health | Positive mental health, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health. | 3 weeks, 6 weeks | 
| Changes in Scores on Associated Phenotypes - Stress | Perceived stress, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates higher levels of perceived stress. | 3 weeks, 6 weeks |