About this trial
The goal of the study is to investigate whether a brief behavioral therapy for insomnia (BBTI) improves sleep in bereaved patients screened for insomnia compared to an active control group (sleep hygiene education). The study will also explore if BBTI improves symptoms of complicated grief. The investigators will recruit approximately 58 bereaved participants with insomnia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Bereaved (experienced the death of a perceived loved one) ≥6 months ago
Insomnia: a score of >10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder
Disqualifiers
Other sleep disor-ders (sleep apnea, parasomnia, narcolepsy)
Use of drugs impacting sleep
Severe psychological or physical disorders that may confound sleep (symptoms of CGR allowed)
Neurodegenerative disorders
Trial design
Parallel
Treatments tested in this trial
Brief Behavioral Therapy for Insomnia
BehavioralBBTI is a multi-component intervention consisting of techniques from sleep restriction and stimulus control therapy. It targets behavioral elements of insomnia using four techniques: 1) reduce time in bed, 2) get up at the same time every day, 3) do not go to bed unless sleepy, and 4) do not stay in bed unless asleep.
Sleep Hygiene Therapy
BehavioralSHE consists of education on lifestyle factors (diet, exercise, substance use) and enviromental variables (noise, light, temperature) affecting sleep quality.
Treatment groups
Trial outcomes
Primary outcomes
Insomnia Severity Index (ISI)
The ISI measures the severity of insomnia symptoms and the associated impact on daytime functioning and distress. The questionnaire consists of 7 questions the sum of which makes up a total score. The ISI has a range of 0-28, with higher scores indicate worse insomnia severity.
Secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Changes in sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with scores ranging from a minimum of 0, indicating no difficulty, to a maximum of 21, indicating severe difficulties in all areas related to sleep.
Consensus Sleep Diary
The Consensus Sleep Diary measures self-reported sleep providing various sleep parameters such as sleep duration, sleep onset latency (SOL), time in bed (TIB), total sleep time (TST), wake after sleep onset (WASO) and sleep efficiency (SE).
Morningness-Eveningness Questionnaire - Revised (MEQr)
The Morningness-Eveningness Questionnaire-reduced (MEQr) will be used to assess circadian rhythm preferences (chronotype). This 5-item questionnaire evaluates sleep-wake patterns, preferred activity times, and subjective alertness at different times of the day. Scores categorize individuals as morning types, evening types, or intermediate types, with higher scores indicating a preference for morningness and lower scores indicating a preference for eveningness.
Aarhus Prolonged Grief Disorder Scale (A-PGDs)
The A-PGDs is a validated self-report instrument that will be used to measure symptoms of prolonged grief disorder, including yearning, emotional pain, difficulty moving on, and functional impairment. Items are rated on a Likert scale, and higher scores reflect more severe grief symptoms.
Sponsors and contacts
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