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Digital CBTI for Comorbid Insomnia in Chronic Migraine

Primary Purpose

Insomnia Chronic, Migraine Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Digital CBT-I
Sleep Hygiene Education
Sponsored by
University of Strathclyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic focused on measuring Cognitive Behaviour Therapy, Digital Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women age 18 and above
  2. Insomnia, satisfied by a total score ≥ 11 on the insomnia severity index (ISI)
  3. Headache ≥ 15 days per month, ≥ 12 months and meet criteria for migraine with/without aura on ≥ 8 days per month, ≥ 12 months

Exclusion Criteria:

  1. Medical condition that is unstable, requires immediate treatment, or is judged to interfere with the protocol, including other pain conditions such as chronic low back pain and fibromyalgia and also sleep disorders such as untreated sleep apnoea or parasomnias.
  2. Psychiatric condition that is judged to interfere with the study protocol including substance abuse, psychotic disorder, cognitive disorder, current suicidal ideation, or any uncontrolled psychiatric conditions that require immediate treatment
  3. Regular use of illegal substances
  4. Women who are pregnant or breastfeeding
  5. Shiftworkers

Sites / Locations

  • GlasgowRecruiting
  • Walton Centre, LiverpoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital CBT-I

Sleep Hygiene Education (SHE)

Arm Description

After assignment to dCBT-I, participants will complete a baseline assessment of their sleep, migraines and other outcomes and complete a 30-day sleep and headache diary, and wear an actigraphy device for 7 days to record their sleep and light exposure. They will then be given access to the 6-session dCBT-I programme. At month 1, participants will wear an actigraph device for 1 week.. At month 3 participants will complete a 30-day post-treatment assessment including a sleep and headache diary and the same battery of questionnaires as during the baseline assessment. A subset of participants (and providers) will be invited to participate in an interview about uptake of dCBT-I. At month 6, all participants will complete follow-up questionnaires (similar to baseline and post-treatment questionnaires) and one last 30-day assessment of sleep and headaches and wear a 7-day actigraphy device.

After assignment to SHE, participants will complete a baseline assessment of their sleep, migraines and other outcomes and complete a 30-day sleep and headache diary, and wear an actigraphy device for 7 days to record their sleep and light exposure. They will then be given access to the 6-session SHE programme. At month 1, participants will wear an actigraph device for 1 week.. At month 3 participants will complete a 30-day post-treatment assessment including a sleep and headache diary and the same battery of questionnaires as during the baseline assessment. A subset of participants (and providers) will be invited to participate in an interview about uptake of SHE. At month 6, all participants will complete follow-up questionnaires (similar to baseline and post-treatment questionnaires) and one last 30-day assessment of sleep and headaches and wear a 7-day actigraphy device.

Outcomes

Primary Outcome Measures

Change in Insomnia Severity
The change in insomnia (measured with the Insomnia Severity Index - ISI) from baseline to posttreatment. The ISI is scored from 0 to 28, where a higher score indicates more severe insomnia severity.
Change in Migraine Days
The change in migraine days (measured with the headache diary) from baseline to posttreatment
Recruitment rate
How many participants have been recruited per month
Retention rate
How many participants have dropped out
Naps
Number (N) of naps
Light exposure
Light exposure measured through an actigraphy device
Barriers and Facilitators to Engagement with the protocol
Measured through qualitative interviews/focus groups

Secondary Outcome Measures

Adverse Events
Adverse Events
Treatment Satisfaction
Measured through in house post-treatment satisfaction questionnaire
Migraine Disability
Measured with Migraine Disability Assessment (MIDAS) questionnaire
Medication use
Captured through headache diaries
Depression and Anxiety
Captured with the Four-Item Patient Health Questionnaire (PHQ-4) for Anxiety and Depression
Cost-utility
Measured with the EQ-5D, health-related quality of life, from which quality adjusted life years (QUALY) can be obtained. This will allow us to calculate cost-utility.
Sleepiness
Measured with Epworth Sleepiness Scale
Fatigue
Measured with Flinders Fatigue Scale (FFS)

Full Information

First Posted
July 7, 2021
Last Updated
December 6, 2022
Sponsor
University of Strathclyde
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1. Study Identification

Unique Protocol Identification Number
NCT05244889
Brief Title
Digital CBTI for Comorbid Insomnia in Chronic Migraine
Official Title
Digital Cognitive Behaviour Therapy for Insomnia in Chronic Migraines: Feasibility of a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
March 21, 2024 (Anticipated)
Study Completion Date
September 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Strathclyde

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall aims of the study are: Aim 1: Estimate effect sizes: To estimate the effects of dCBT-I on insomnia symptoms compared to a control group (sleep hygiene education) and estimate the relationship between changes in insomnia symptoms and the reduction in migraines. Aim 2: Explore mechanisms of change: To explore the mechanisms underlining the change in migraine symptoms. Aim 3: Assess barriers to conducting a full-scale RCT: To collect data on recruitment pace and dropouts in both groups, which will help refine the methodology and maximise uptake and retention of a full-scale randomised control trial (RCT). The investigators will conduct qualitative interviews with a select number of participants and practitioners to identify motivators/barriers in uptake of a digitalised version of CBT-I.
Detailed Description
Chronic migraine (CM) is a debilitating condition that places a direct burden worth £150 million on the NHS per year. Previous research has shown that insomnia is a risk factor for migraines. The investigators hypothesise that two modifiable behaviours explain this relationship between insomnia and migraines: daytime napping and nocturnal light exposure. To cope with the migraines, individuals will nap during the day, reducing the homeostatic drive for sleep at night and delaying sleep onset. This inability to fall asleep potentially increases exposure to evening bright light, delaying the release of the hormone melatonin and reducing sleep quality. Poor sleep in turn is a trigger for migraines, which creates a vicious cycle of migraines and poor sleep. The investigators believe that these behavioural mechanisms are valid targets for treatment and are explicitly addressed in Cognitive Behaviour Therapy for insomnia (CBT-I). Digital versions of CBT-I (dCBT-I) offer a scalable solution to the problem of limited access to CBT-I. This research group has demonstrated the feasibility, acceptability and preliminary efficacy of dCBT-I in an uncontrolled proof-of concept study. Utilising randomised control trial (RCT) methodology, the investigator's aim now is to evaluate the effectiveness of dCBT-I for improving insomnia and migraines in patients with chronic migraines. The second aim is to probe mechanism of change and to test the hypotheses that behavioural markers such as daytime napping and evening light exposure can reduce insomnia symptoms leading to an improvement in migraines. Prior to progressing to a full-scale RCT, the investigators require a feasibility RCT, to refine the methodology. The investigators propose to recruit individuals who meet criteria for CM and insomnia, directly referred from two neurology clinics, who will act as clinical recruiters. Eighty-eight participants will be randomised either to a dCBT-I group or to sleep hygiene education (SHE) control group. The main outcomes are insomnia and migraine days and will be collected at post-treatment, and long-term effects will be assessed at month 6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic, Migraine Disorders
Keywords
Cognitive Behaviour Therapy, Digital Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals will be randomly assigned to a dCBT-I or the sleep hygiene education control group.
Masking
Outcomes Assessor
Masking Description
While the study will be single-blinded (researchers analysing data will be blind to allocation), randomisation will be concealed to the RA and participant until the individual's eligibility has been established.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital CBT-I
Arm Type
Experimental
Arm Description
After assignment to dCBT-I, participants will complete a baseline assessment of their sleep, migraines and other outcomes and complete a 30-day sleep and headache diary, and wear an actigraphy device for 7 days to record their sleep and light exposure. They will then be given access to the 6-session dCBT-I programme. At month 1, participants will wear an actigraph device for 1 week.. At month 3 participants will complete a 30-day post-treatment assessment including a sleep and headache diary and the same battery of questionnaires as during the baseline assessment. A subset of participants (and providers) will be invited to participate in an interview about uptake of dCBT-I. At month 6, all participants will complete follow-up questionnaires (similar to baseline and post-treatment questionnaires) and one last 30-day assessment of sleep and headaches and wear a 7-day actigraphy device.
Arm Title
Sleep Hygiene Education (SHE)
Arm Type
Active Comparator
Arm Description
After assignment to SHE, participants will complete a baseline assessment of their sleep, migraines and other outcomes and complete a 30-day sleep and headache diary, and wear an actigraphy device for 7 days to record their sleep and light exposure. They will then be given access to the 6-session SHE programme. At month 1, participants will wear an actigraph device for 1 week.. At month 3 participants will complete a 30-day post-treatment assessment including a sleep and headache diary and the same battery of questionnaires as during the baseline assessment. A subset of participants (and providers) will be invited to participate in an interview about uptake of SHE. At month 6, all participants will complete follow-up questionnaires (similar to baseline and post-treatment questionnaires) and one last 30-day assessment of sleep and headaches and wear a 7-day actigraphy device.
Intervention Type
Behavioral
Intervention Name(s)
Digital CBT-I
Intervention Description
The digital CBT-I intervention (www.sleepio.com) consists of six weekly sessions of CBT-I delivered over the internet by an animated virtual therapist known as "The Prof". The content includes behavioral (e.g. sleep restriction, stimulus control), cognitive (e.g. putting the day to rest, thought re-structuring, mindfulness) strategies, relaxation strategies (e.g., progressive muscle relaxation) and advice on lifestyle and bedroom factors (sleep hygiene). Although the sessions can be completed at the persons own pace, the shortest interval between individual sessions is 7 days, thus participants can complete the course in 6 weeks, or take as long as 12 weeks. As part of the SLEEPIO program, participants will be required to enter their sleep/wake patterns using electronic sleep diaries. There is no face-to-face contact throughout the intervention and all treatment sessions, support and reminders are provided through the online platform.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Education
Intervention Description
Sleep Hygiene Education (SHE) has successfully been used as a control condition in other trials evaluating dCBT-I42. SHE does not have any therapeutic benefits for individuals with insomnia alone, but is often part of usual care. Consequently it is a credible alternative to dCBT-I. The sleep hygiene education will be provided on a website with access to information about lifestyle changes (e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine) and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal room temperature). As with the dCBT-I group, participants will not be required to make any changes to their usual care.
Primary Outcome Measure Information:
Title
Change in Insomnia Severity
Description
The change in insomnia (measured with the Insomnia Severity Index - ISI) from baseline to posttreatment. The ISI is scored from 0 to 28, where a higher score indicates more severe insomnia severity.
Time Frame
Posttreatment (3 months after intervention starts).
Title
Change in Migraine Days
Description
The change in migraine days (measured with the headache diary) from baseline to posttreatment
Time Frame
Posttreatment (3 months after intervention starts).
Title
Recruitment rate
Description
How many participants have been recruited per month
Time Frame
Monthly throughout study completion
Title
Retention rate
Description
How many participants have dropped out
Time Frame
Through study completion, up to 3 years
Title
Naps
Description
Number (N) of naps
Time Frame
Mid treatment (Month 1-2 of study)
Title
Light exposure
Description
Light exposure measured through an actigraphy device
Time Frame
Mid treatment (Month 1-2 of study)
Title
Barriers and Facilitators to Engagement with the protocol
Description
Measured through qualitative interviews/focus groups
Time Frame
Post-treatment (3 months after the intervention started)
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse Events
Time Frame
Through study completion, up to 3 years
Title
Treatment Satisfaction
Description
Measured through in house post-treatment satisfaction questionnaire
Time Frame
Post-treatment (3 months after the intervention started)
Title
Migraine Disability
Description
Measured with Migraine Disability Assessment (MIDAS) questionnaire
Time Frame
Post-treatment (3 months after the intervention started)
Title
Medication use
Description
Captured through headache diaries
Time Frame
Post-treatment (3 months after the intervention started)
Title
Depression and Anxiety
Description
Captured with the Four-Item Patient Health Questionnaire (PHQ-4) for Anxiety and Depression
Time Frame
Post-treatment (3 months after the intervention started)
Title
Cost-utility
Description
Measured with the EQ-5D, health-related quality of life, from which quality adjusted life years (QUALY) can be obtained. This will allow us to calculate cost-utility.
Time Frame
Post-treatment (3 months after the intervention started)
Title
Sleepiness
Description
Measured with Epworth Sleepiness Scale
Time Frame
Post-treatment (3 months after the intervention started)
Title
Fatigue
Description
Measured with Flinders Fatigue Scale (FFS)
Time Frame
Post-treatment (3 months after the intervention started)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women age 18 and above Insomnia, satisfied by a total score ≥ 11 on the insomnia severity index (ISI) Headache ≥ 15 days per month, ≥ 12 months and meet criteria for migraine with/without aura on ≥ 8 days per month, ≥ 12 months Exclusion Criteria: Medical condition that is unstable, requires immediate treatment, or is judged to interfere with the protocol, including other pain conditions such as chronic low back pain and fibromyalgia and also sleep disorders such as untreated sleep apnoea or parasomnias. Psychiatric condition that is judged to interfere with the study protocol including substance abuse, psychotic disorder, cognitive disorder, current suicidal ideation, or any uncontrolled psychiatric conditions that require immediate treatment Regular use of illegal substances Women who are pregnant or breastfeeding Shiftworkers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan R Crawford, PhD
Phone
01415482669
Email
hass-research-missionstudy@strath.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise McKean
Organizational Affiliation
University of Strathclyde
Official's Role
Study Chair
Facility Information:
Facility Name
Glasgow
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Gorrie, MD
Facility Name
Walton Centre, Liverpool
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Ghadiri-Sani, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Digital CBTI for Comorbid Insomnia in Chronic Migraine

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