Sleep Difficulties After Loss: Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Brief Behavioral Therapy for Insomnia

    Behavioral

    BBTI 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

    Behavioral

    SHE consists of education on lifestyle factors (diet, exercise, substance use) and enviromental variables (noise, light, temperature) affecting sleep quality.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Intervention group (group 1)Experimental treatment 1 intervention
Group B: Active control group (group 2)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).

Secondary outcomes

1

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.

Time frame
Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
2

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).

Time frame
Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
3

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.

Time frame
Time Frame: Time Frame: Baseline (week 0)
4

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.

Time frame
Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).

Other outcomes

Sponsors and contacts

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