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

Sleep Problem Clinical Trial

— STOP-Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062891
• Other study ID #: STOP-0001-PILOT
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2017
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Problem

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Goldsmiths, University of London	London
United Kingdom	King's College London	London
United Kingdom	Queen Mary, University of London	London

Sponsors (4)

Lead Sponsor	Collaborator
King's College London	Goldsmiths, University of London, Queen Mary University of London, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Eley TC, Hudson JL, Creswell C, Tropeano M, Lester KJ, Cooper P, Farmer A, Lewis CM, Lyneham HJ, Rapee RM, Uher R, Zavos HM, Collier DA. Therapygenetics: the 5HTTLPR and response to psychological therapy. Mol Psychiatry. 2012 Mar;17(3):236-7. doi: 10.1038/mp.2011.132. Epub 2011 Oct 25. — View Citation

Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872. — View Citation

Harvey AG. Insomnia: symptom or diagnosis? Clin Psychol Rev. 2001 Oct;21(7):1037-59. Review. — View Citation

Hudson JL, Keers R, Roberts S, Coleman JR, Breen G, Arendt K, Bögels S, Cooper P, Creswell C, Hartman C, Heiervang ER, Hötzel K, In-Albon T, Lavallee K, Lyneham HJ, Marin CE, McKinnon A, Meiser-Stedman R, Morris T, Nauta M, Rapee RM, Schneider S, Schneider SC, Silverman WK, Thastum M, Thirlwall K, Waite P, Wergeland GJ, Lester KJ, Eley TC. Clinical Predictors of Response to Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders: The Genes for Treatment (GxT) Study. J Am Acad Child Adolesc Psychiatry. 2015 Jun;54(6):454-63. doi: 10.1016/j.jaac.2015.03.018. Epub 2015 Apr 1. — View Citation

Hudson JL, Lester KJ, Lewis CM, Tropeano M, Creswell C, Collier DA, Cooper P, Lyneham HJ, Morris T, Rapee RM, Roberts S, Donald JA, Eley TC. Predicting outcomes following cognitive behaviour therapy in child anxiety disorders: the influence of genetic, demographic and clinical information. J Child Psychol Psychiatry. 2013 Oct;54(10):1086-94. doi: 10.1111/jcpp.12092. Epub 2013 Jun 18. — View Citation

Kessler RC, Berglund PA, Coulouvrat C, Hajak G, Roth T, Shahly V, Shillington AC, Stephenson JJ, Walsh JK. Insomnia and the performance of US workers: results from the America insomnia survey. Sleep. 2011 Sep 1;34(9):1161-71. doi: 10.5665/SLEEP.1230. Erratum in: Sleep. 2011;34(11):1608. Sleep. 2012 Jun;35(6):725. — View Citation

Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006 Nov;29(11):1398-414. Review. — View Citation

Roberts S, Lester KJ, Hudson JL, Rapee RM, Creswell C, Cooper PJ, Thirlwall KJ, Coleman JR, Breen G, Wong CC, Eley TC. Serotonin transporter [corrected] methylation and response to cognitive behaviour therapy in children with anxiety disorders. Transl Psychiatry. 2014 Sep 16;4:e444. doi: 10.1038/tp.2014.83. Erratum in: Transl Psychiatry. 2014;4:e467. — View Citation

Vgontzas AN, Fernandez-Mendoza J, Liao D, Bixler EO. Insomnia with objective short sleep duration: the most biologically severe phenotype of the disorder. Sleep Med Rev. 2013 Aug;17(4):241-54. doi: 10.1016/j.smrv.2012.09.005. Epub 2013 Feb 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Online CBT for Insomnia in Sleep Paralysis	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.	Change from baseline to 6 weeks
Other	Phenotypic Associations With Exploding Head Syndrome	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.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Sleepio website - the online CBT platform used in the study