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NCT Number: NCT03062891

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

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:

1. Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample? 2. 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: 3. 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. 4. 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Goldsmiths, University of London, London, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Online CBT for insomnia

Procedure

See CBT arm description for information about the CBT intervention. More details can be found in source 4 in the reference list.

Primary outcomes

  1. Improvement in Insomnia Symptoms Following Online CBT

    Time frame: Change from baseline to 3 weeks, 6 weeks, and 6 months

    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.

  2. Improvement in Sleep Quality Following Online CBT

    Time frame: Change from baseline to 3 weeks, 6 weeks, and 6 months

    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.

  3. Treatment Acceptability Mid-intervention

    Time frame: 3 weeks

    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.

  4. Treatment Acceptability at the End of the Intervention

    Time frame: 6 weeks

    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.

  5. Change in Treatment Acceptability During the Intervention

    Time frame: Change from baseline to 3 weeks and 6 weeks

    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.

  6. Attrition Rate

    Time frame: 6 months

    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.

Secondary outcomes

  1. Predictors of Treatment Outcome - Anxiety

    Time frame: Baseline

    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

  2. Predictors of Treatment Outcome - Depression

    Time frame: Baseline

    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

  3. Predictors of Treatment Outcome - Attentional Problems

    Time frame: Baseline

    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

  4. Predictors of Treatment Outcome - Psychotic Experiences

    Time frame: Baseline

    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

  5. Predictors of Treatment Outcome - Positive Mental Health

    Time frame: Baseline

    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

  6. Predictors of Treatment Outcome - Stress

    Time frame: Baseline

    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

  7. Predictors of Treatment Outcome - Threatening Life Events

    Time frame: Baseline

    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

  8. Changes in Scores on Associated Phenotypes - Anxiety

    Time frame: 3 weeks, 6 weeks

    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.

  9. Changes in Scores on Associated Phenotypes - Depression

    Time frame: 3 weeks, 6 weeks

    Depression symptoms, as measured using the Trait State Anxiety Index. The theoretical range is 0-26, and a higher score indicates more depression symptoms.

  10. Changes in Scores on Associated Phenotypes - Attentional Problems

    Time frame: 3 weeks, 6 weeks

    Attentional problems, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems.

  11. Changes in Scores on Associated Phenotypes - Psychotic Experiences

    Time frame: 6 weeks

    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

  12. Changes in Scores on Associated Phenotypes - Positive Mental Health

    Time frame: 3 weeks, 6 weeks

    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.

  13. Changes in Scores on Associated Phenotypes - Stress

    Time frame: 3 weeks, 6 weeks

    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.

Other outcomes

  1. Online CBT for Insomnia in Sleep Paralysis

    Time frame: Change from baseline to 6 weeks

    Sleep paralysis is a relatively common but understudied phenomenon that has the potential to cause large amounts of fear and/or distress in individuals who experience it. As an exploratory analysis, it shall be investigated whether individuals assigned to the CBT intervention who also experience sleep paralysis show any reductions in the frequency of episodes, and associate levels of fear/distress throughout the programme.

    As this isn't a main aim of the study, this aim is dependent upon a sufficient number of participants who experience sleep paralysis being present in the sample. It is unlikely that there will be sufficient power to thoroughly assess this, but it is hoped this will provide helpful information to future studies.

  2. Phenotypic Associations With Exploding Head Syndrome

    Time frame: Baseline

    Exploding head syndrome is an unusual and understudied phenomenon associated with sleep. Measures included in this study shall be used in an exploratory fashion to perform a cross-sectional analysis looking at associations between exploding head syndrome and factors such as sleep problems, depression, anxiety, and well-being.

    Exploding head syndrome was measured using a 1-5 scale, where 1 = never experienced and 5 = several times a week. Sleep paralysis was measured using a 1-7 scale ranging from 1 = never observed to 7 = several times a week.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Goldsmiths, University of London
  • Queen Mary University of London
  • University of Oxford

Registry information

Acronym: STOP-Pilot

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2017
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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