An interventional study of Sleep Restriction Therapy (SRT) and Sleep Hygiene Education (SHE) in Acute Insomnia (Disorder), sponsored by University of Strathclyde. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by University of Strathclyde · Not applicable, Interventional, and Other
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.
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.
1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's planned enrollment of 50 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Strathclyde is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
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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
Exclusion Criteria:
Main study exclusion criteria are limited to conditions contraindicated for SRT or factors that would preclude implementation of SRT.
Behavioral: Sleep Restriction Therapy (SRT)
Behavioral: Sleep Hygiene Education (SHE)
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
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.
Recruitment rates
Enrolment logs for all consenting patients. Pre-screen failure logs for patients who meet inclusion criteria but are not enrolled
Time frame: Screening
Retention rates
Completion of outcome measures
Time frame: 3 months post randomisation
Intervention fidelity: Therapist adherence
Independent clinician review of recorded SRT sessions and completion of fidelity rating scale
Time frame: 6 weeks post randomisation
Intervention fidelity: Patient engagement
Intervention attendance logs completion of fidelity rating scale
Time frame: During intervention phase
Intervention fidelity: Control group contamination
Client Service Receipt Inventory
Time frame: 6 weeks and 3 months post randomisation
Outcome measure completion
Completion of study questionnaires
Time frame: 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
Time frame: Beginning 8 weeks post-randomisation to approx. 1 year after start of recruitment
Improvement in insomnia severity
Insomnia Severity Index (ISI)
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [depression]
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [anxiety]
Generalised Anxiety Disorders - 7 (GAD-7)
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F)
Functional Assessment of Cancer Therapy -
Time frame: Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms
Actigraphy
Time frame: Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Improvement in sleep [estimates of subjective sleep]
Sleep Diary
Time frame: Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Measure of health related quality of life
EQ-5D-5L
Time frame: Baseline, 6 weeks and 3 months post-randomisation
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
University of Strathclyde