Health professional Administered Brief Insomnia Therapy (HABIT) trial
- Conditions
- InsomniaDisorders of initiating and maintaining sleep [insomnias]Mental and Behavioural Disorders
- Registration Number
- ISRCTN42499563
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32139496/ protocol (added 15/02/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37573859/ (added 14/08/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39185919/ (added 27/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 642
Current participant inclusion criteria as of 19/02/2020:
1. Participant is willing and able to give informed consent for participation in the study
2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM-5 (American Psychiatric Association) on structured checklist review
3. Sleep efficiency < 85% over the past month
4. Age =18 years
5. Able to attend appointments during baseline and 4-week intervention (both face-to-face at the practice and over the phone) and adhere to study procedures
6. Registered at a GP practice taking part in the trial
Previous participant inclusion criteria:
1. Participant is willing and able to give informed consent for participation in the study
2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM-5 (American Psychiatric Association) on structured checklist review
3. Sleep efficiency < 85% over the past month
4. Age =18 years
5. Able to attend appointments during baseline and 4-week intervention (both face-to-face at the practice and over the phone) and adhere to study procedures
Current participant exclusion criteria as of 19/02/2020:
1. Pregnant/pregnancy planning in the next 6 months
2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
3. Dementia/ Mild Cognitive Impairment (MCI)
4. Epilepsy
5. Psychosis (schizophrenia, bipolar disorder)
6. Current suicidal ideation with intent OR attempted suicide within past 2 months
7. Currently receiving cancer treatment OR planned major surgery during treatment phase
8. Night, evening, early morning or rotating shift-work
9. Currently receiving psychological treatment for insomnia from a health professional
10. Life expectancy of <2 years
11. Another person in the same household participates in this trial
Previous exclusion criteria as of 17/09/2019:
1. Pregnant/pregnancy planning in the next 6 months
2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
3. Dementia/ Mild Cognitive Impairment (MCI)
4. Epilepsy
5. Psychosis (schizophrenia, bipolar disorder)
6. Current suicidal ideation with intent OR attempted suicide within past 2 months
7. Currently receiving cancer treatment OR planned major surgery during treatment phase
8. Night, evening, early morning or rotating shift-work
9. Currently receiving psychological treatment for insomnia from a health professional
10. Life expectancy of < 2 years
Previous exclusion criteria as of 21/08/2018:
1. Pregnant/pregnancy planning in the next 6 months
2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
3. Dementia
4. Epilepsy
5. Psychosis (schizophrenia, bipolar disorder)
6. Current suicidal ideation with intent OR attempted suicide within past 2 months
7. Currently receiving cancer treatment OR planned major surgery during treatment phase
8. Night, evening, early morning or rotating shift-work
9. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia.
10. Life expectancy of <2 years
Previous exclusion criteria:
1. Pregnant/pregnancy planning in the next 6 months
2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
3. Dementia
4. Epilepsy
5. Psychosis (schizophrenia, bipolar disorder)
6. Current suicidal ideation with intent OR attempted suicide within past 2 months
7. Currently receiving cancer treatment OR planned major surgery during treatment phase
8. Night, evening, early morning or rotating shift-work
9. Trans-meridian travel planned during the baseline assessments or for > 3 nights during treatment phase
10. Currently receiving psychological treatment for insomnia from a health professional
11. Life expectancy of < 2 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self-rated insomnia severity using the insomnia severity index (ISI) questionnaire collected at baseline, 3, 6 and 12 months post randomization. Primary outcome is at 6 months.
- Secondary Outcome Measures
Name Time Method