Acute Insomnia (Disorder)INVESTNCT06294041
INvestigating the Value of Early Sleep Therapy
A study testing Sleep Restriction Therapy (SRT) and Sleep Hygiene Education (SHE) in people with Acute Insomnia (Disorder), run by University of Strathclyde.
Trial summary
Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Insomnia (Disorder)
- What is being tested?
- Sleep Restriction Therapy (SRT) and Sleep Hygiene Education (SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent
- Aged 18 years and above
- Screen positive for acute insomnia, defined as dissatisfaction with sleep quality or duration, accompanied by other night / daytime symptoms, present for between 2 weeks and 3 months
- Newly diagnosed with non-metastatic breast cancer
- Primary cancer treatment is surgery
Who cannot join
- Main study exclusion criteria are limited to conditions contraindicated for SRT or factors that would preclude implementation of SRT.
- Pregnancy
- Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) or screen "positive" for additional sleep disorder at study screening interview
- Dementia / Mild Cognitive Impairment
- Epilepsy
- Psychosis (schizophrenia, bipolar disorder)
Show all 10Show fewer
- Current suicidal ideation with intent or attempted suicide within past 2 months
- Night, evening, early morning, or rotating shiftwork
- Current / previous psychological treatment for insomnia during the last 12 months
- Chemotherapy and / or radiotherapy commenced
Trial locations and contacts
No sites are listed yet.
Solveiga Zibaite, PhD contact
About this study
Official title: A Pilot Randomised Control Trial of Sleep Restriction Therapy Versus Sleep Hygiene Education for Newly Diagnosed Breast Cancer Patients With Acute Insomnia
Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia.
Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.
This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise.
Read the detailed description
The primary aim of this project is to assess the feasibility and inform the design of a full-scale RCT of SRT for newly diagnosed breast cancer patients with acute insomnia. Secondary aims of this project are to assess the effects of SRT alongside a sleep hygiene education (SHE) control on sleep, rest-activity rhythms, and mental health.
Participants will be recruited from breast cancer results clinics in two study sites. Our target population is newly diagnosed, non-metastatic patients whose primary cancer treatment is surgery. Participants will go through initial screening and will be sent an online participant information sheet and consent form. Once consent form is signed, marking enrolment in the study, the second stage of screening will commence. It involves assessing current sleep status (based on diagnostic criteria for acute insomnia) current psychiatric symptoms and review of other relevant medical information (diagnosis of other sleep disorders, other medical and psychiatric disorders). This is to confirm the diagnosis of acute insomnia and establish that there are no medical or psychiatric conditions that might preclude someone from taking part in the study. Once eligibility is ascertained, patients will be randomly assigned to SRT or the SHE control group. The investigators aim to randomise 50 patients (n=25 in each trial arm).
After randomisation to SRT or SHE, patients will be sent an email with a link to complete a baseline (pre-intervention) assessment of sleep, fatigue, and mental health. Patients will also be required to complete the consensus sleep diary and wear an actigraphy device for 7 days prior to commencement of SRT/SHE to record sleep and rest/activity rhythms. After completion of the baseline assessment, patients will either be referred to the research nurse for commencement of the SRT protocol or provided with the SHE resource. At 6 weeks, and 3 months post-randomisation, patients will be requested to complete the same battery of questionnaires as during the baseline assessment. Following completion of the final study assessment (3 months post-randomisation), those randomised to the SHE condition will be offered the opportunity to complete the SRT protocol without the requirement to complete any further assessments.
Interventions: Sleep Restriction Therapy (SRT)
SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I. Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase. SRT will be delivered by trained research nurses.
Sleep Hygiene Education (SHE)
SHE will be delivered via a booklet that provides 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). Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period.
- Conditions
- Acute Insomnia (Disorder)
- Being tested
- Sleep Restriction Therapy (SRT), Sleep Hygiene Education (SHE)
- Keywords
- acute insomnia, breast cancer, prehabilitation, sleep restriction therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Restriction Therapy (SRT)Behavioural
SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I. Our SRT protocol involves standardising and (where required) limiting a patient's time in bed with the aim of increasing homeostatic sleep pressure, over-riding cognitive and physiological arousal, and strengthening circadian control of sleep. Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase. The intervention will be delivered by trained research nurses
Sleep Hygiene Education (SHE)Behavioural
SHE will be delivered via a booklet that provides 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). Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period. One week after randomisation to SHE, the RA will telephone patients to check they understand the SHE advice and answer any questions they may have. SHE has successfully been used as a control condition in other trials evaluating SRT and does not have any therapeutic benefit for individuals with insomnia but is often part of usual care, so is a credible alternative to SRT.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Restriction Therapy (SRT) | Other | Not described Receives: Behavioral: Sleep Restriction Therapy (SRT) |
| Sleep Hygiene Education | Other | Not described Receives: Behavioral: Sleep Hygiene Education (SHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Enrolment logs for all consenting patients. Pre-screen failure logs for patients who meet inclusion criteria but are not enrolled
Measured: Screening
Retention rates
Completion of outcome measures
Measured: 3 months post randomisation
Intervention fidelity: Therapist adherence
Independent clinician review of recorded SRT sessions and completion of fidelity rating scale
Measured: 6 weeks post randomisation
Intervention fidelity: Patient engagement
Intervention attendance logs
completion of fidelity rating scale
Measured: During intervention phase
Intervention fidelity: Control group contamination
Client Service Receipt Inventory
Measured: 6 weeks and 3 months post randomisation
Outcome measure completion
Completion of study questionnaires
Measured: Baseline, 6 weeks and 3 months post randomisation
Intervention acceptability
semi-structured interviews with 10 patients from SRT arm, 5 from SHE arm and with 5 members of clinical staff
Measured: Beginning 8 weeks post-randomisation to approx. 1 year after start of recruitment
Secondary outcomes (7)
Improvement in insomnia severity
Insomnia Severity Index (ISI)
Measured: Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [depression]
Patient Health Questionnaire 9 (PHQ-9)
Measured: Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [anxiety]
Generalised Anxiety Disorders - 7 (GAD-7)
Measured: Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F)
Functional Assessment of Cancer Therapy -
Measured: Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms
Actigraphy
Measured: Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Improvement in sleep [estimates of subjective sleep]
Sleep Diary
Measured: Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Measure of health related quality of life
EQ-5D-5L
Measured: Baseline, 6 weeks and 3 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Insomnia (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Glasgow, NHS Greater Glasgow and Clyde, NHS Grampian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294041
- Sponsor's protocol ID
- UEC23/52
- Acronym
- INVEST
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fleming L, Zibaite S, Kyle SD, Boyd K, Green V, Mansell J, Elsberger B, Young D. Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial). PLoS One. 2024 Aug 14;19(8):e0305304. doi: 10.1371/journal.pone.0305304. eCollection 2024.
PubMed 39141622
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Control Trial of Sleep Restriction Therapy Versus Sleep Hygiene Education for Newly Diagnosed Breast Cancer Patients With Acute Insomnia
- ClinicalTrials.gov ID
- NCT06294041
- Acronym / sponsor ID
- INVEST / UEC23/52
- Conditions
- Acute Insomnia (Disorder)
- Keywords
- acute insomnia, breast cancer, prehabilitation, sleep restriction therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Collaborators
- University of Oxford, University of Glasgow, NHS Greater Glasgow and Clyde, NHS Grampian
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia.
Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.
This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise.
Detailed description
The primary aim of this project is to assess the feasibility and inform the design of a full-scale RCT of SRT for newly diagnosed breast cancer patients with acute insomnia. Secondary aims of this project are to assess the effects of SRT alongside a sleep hygiene education (SHE) control on sleep, rest-activity rhythms, and mental health.
Participants will be recruited from breast cancer results clinics in two study sites. Our target population is newly diagnosed, non-metastatic patients whose primary cancer treatment is surgery. Participants will go through initial screening and will be sent an online participant information sheet and consent form. Once consent form is signed, marking enrolment in the study, the second stage of screening will commence. It involves assessing current sleep status (based on diagnostic criteria for acute insomnia) current psychiatric symptoms and review of other relevant medical information (diagnosis of other sleep disorders, other medical and psychiatric disorders). This is to confirm the diagnosis of acute insomnia and establish that there are no medical or psychiatric conditions that might preclude someone from taking part in the study. Once eligibility is ascertained, patients will be randomly assigned to SRT or the SHE control group. The investigators aim to randomise 50 patients (n=25 in each trial arm).
After randomisation to SRT or SHE, patients will be sent an email with a link to complete a baseline (pre-intervention) assessment of sleep, fatigue, and mental health. Patients will also be required to complete the consensus sleep diary and wear an actigraphy device for 7 days prior to commencement of SRT/SHE to record sleep and rest/activity rhythms. After completion of the baseline assessment, patients will either be referred to the research nurse for commencement of the SRT protocol or provided with the SHE resource. At 6 weeks, and 3 months post-randomisation, patients will be requested to complete the same battery of questionnaires as during the baseline assessment. Following completion of the final study assessment (3 months post-randomisation), those randomised to the SHE condition will be offered the opportunity to complete the SRT protocol without the requirement to complete any further assessments.
Interventions: Sleep Restriction Therapy (SRT)
SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I. Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase. SRT will be delivered by trained research nurses.
Sleep Hygiene Education (SHE)
SHE will be delivered via a booklet that provides 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). Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction Therapy (SRT) | Other | Behavioral: Sleep Restriction Therapy (SRT) |
| Sleep Hygiene Education | Other | Behavioral: Sleep Hygiene Education (SHE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent
- Aged 18 years and above
- Screen positive for acute insomnia, defined as dissatisfaction with sleep quality or duration, accompanied by other night / daytime symptoms, present for between 2 weeks and 3 months
- Newly diagnosed with non-metastatic breast cancer
- Primary cancer treatment is surgery
Key exclusion criteria (10 listed)
- Main study exclusion criteria are limited to conditions contraindicated for SRT or factors that would preclude implementation of SRT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Restriction Therapy (SRT)SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I. Our SRT protocol involves standardising and (where required) limiting a patient's time in bed with the aim of increasing homeostatic sleep pressure, over-riding cognitive and physiological arousal, and strengthening circadian control of sleep. Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase. The intervention will be delivered by trained research nurses | Behavioural | Sleep Restriction Therapy (SRT) |
| Sleep Hygiene Education (SHE)SHE will be delivered via a booklet that provides 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). Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period. One week after randomisation to SHE, the RA will telephone patients to check they understand the SHE advice and answer any questions they may have. SHE has successfully been used as a control condition in other trials evaluating SRT and does not have any therapeutic benefit for individuals with insomnia but is often part of usual care, so is a credible alternative to SRT. | Behavioural | Sleep Hygiene Education |
Primary outcome
Recruitment rates
Time frame: Screening
Enrolment logs for all consenting patients. Pre-screen failure logs for patients who meet inclusion criteria but are not enrolled
Retention rates
Time frame: 3 months post randomisation
Completion of outcome measures
Intervention fidelity: Therapist adherence
Time frame: 6 weeks post randomisation
Independent clinician review of recorded SRT sessions and completion of fidelity rating scale
Intervention fidelity: Patient engagement
Time frame: During intervention phase
Intervention attendance logs completion of fidelity rating scale
Intervention fidelity: Control group contamination
Time frame: 6 weeks and 3 months post randomisation
Client Service Receipt Inventory
Outcome measure completion
Time frame: Baseline, 6 weeks and 3 months post randomisation
Completion of study questionnaires
Intervention acceptability
Time frame: Beginning 8 weeks post-randomisation to approx. 1 year after start of recruitment
semi-structured interviews with 10 patients from SRT arm, 5 from SHE arm and with 5 members of clinical staff
7 secondary outcomes
Improvement in insomnia severity
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [depression]
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [anxiety]
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F)
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms
Time frame: Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Improvement in sleep [estimates of subjective sleep]
Time frame: Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Measure of health related quality of life
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 39141622Fleming L, Zibaite S, Kyle SD, Boyd K, Green V, Mansell J, Elsberger B, Young D. Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial). PLoS One. 2024 Aug 14;19(8):e0305304. doi: 10.1371/journal.pone.0305304. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solveiga Zibaite, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction Therapy (SRT) and Sleep Hygiene Education (SHE) in people with Acute Insomnia (Disorder), run by University of Strathclyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leanne Fleming, PhD (01415482573, l.fleming@strath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: Screening). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06294041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.