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Not yet recruiting NCT07167706

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

No phase Interventional Insomnia Insomnia Chronic Complicated Grief

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief Behavioral Therapy for Insomnia, Sleep Hygiene Therapy.
Who it may be relevant to
Registry conditions: Insomnia, Insomnia Chronic, Complicated Grief. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

The study is a randomized controlled trial comparing the effect of a brief behavioral therapy for insomnia (BBTI) on insomnia with an active control group (sleep hygiene). Participants will be 58 bereaved individuals who experience insomnia. After baseline assessment, participants will be randomized to either BBTI or sleep hygiene (active control). Both groups will undergo post-treatment assessments as well as 3- and 6-months follow-up assessments. The primary outcomes will be insomnia assessed with the Insomnia Severity Index (ISI) and improvements in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and sleep parameters using the consensus sleep diary. The secondary outcome will be complicated grief reactions (CGR) using the Aarhus Prolonged Grief Disorder scale (A-PGDs, prolonged grief). the Center of Epidemiological Studies Depression Scale (CESD-10, depression), the General Anxiety Disorder-7 questionnaire (GAD-7; anxiety), and the short-form PTSD Checklist for DSM-5 (PCL-5; PTSD).

The study has the following aims and hypotheses:

PRIMARY AIM: To investigate whether BBTI improves sleep in bereaved patients screened for insomnia when compared to an active control group.

PRIMARY HYPOTHESIS: Compared with the active control group, participants receiving BBTI will show statistically significant reductions in insomnia using the ISI, as well as improvements in sleep quality using the PSQI and sleep parameters using the consensus sleep diary.

SECONDARY AIM: To explore whether BBTI improves CGR in bereaved patients screened for insomnia when compared to an active control group.

SECONDARY HYPOTHESIS: Compared with the active control group, participants receiving BBTI will show statistically significant reductions in CGR using the A-PGDs, the CESD-10, the GAD-7, and the PCL-5.

Interventions

  • Behavioral Brief Behavioral Therapy for Insomnia
    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.
  • Behavioral Sleep Hygiene Therapy
    SHE consists of education on lifestyle factors (diet, exercise, substance use) and enviromental variables (noise, light, temperature) affecting sleep quality.

Primary outcome measures

  • Insomnia Severity Index (ISI) [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 outcome measures (12)
  • Pittsburgh Sleep Quality Index (PSQI) [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).]
  • Consensus Sleep Diary [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).]
  • Morningness-Eveningness Questionnaire - Revised (MEQr) [Time frame: Time Frame: Time Frame: Baseline (week 0)]
  • Aarhus Prolonged Grief Disorder Scale (A-PGDs) [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).]
  • Center for Epidemiological Studies Depression Scale - 10 Item Version (CESD-10) [Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).]
  • Generalized Anxiety Disorder - 7 Item Scale (GAD-7) [Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).]
  • PTSD Checklist for DSM-5 - Short Form (PCL-5 - Short Form) [Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).]
  • My Grief [Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).]
  • The perceived stress scale (PSS) [Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).]
  • The Short-Form (12) Health Survey (SF-12) [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).]
  • World Health Organization-Five Well-Being Index (WHO-5) [Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).]
  • NEO Personality Inventory - Revised (NEO-PI-R), Neuroticism Only [Time frame: Baseline (week 0)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Shift work
  • Insufficient Danish proficiency
  • Previous experience with BBTI or cognitive behavioral therapy for insomnia (CBT-I)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Aarhus University — Aarhus

Identifiers

NCT: NCT07167706 · 116242

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗