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

NCT07167706 | Not Yet Recruiting

• 1 other identifier: 116242
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Insomnia Chronic; Complicated Grief

Keywords

Insomnia; Insomnia Chronic; Brief Behavioral Therapy for Insomnia; BBTI; Sleep; Sleep Quality; Complicated Grief; Grief; Bereavement; Complicated Grief Reactions

Outcome Measures

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

Secondary Outcomes (14)

• Pittsburgh Sleep Quality Index (PSQI)

  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: 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: Baseline (week 0)

• Aarhus Prolonged Grief Disorder Scale (A-PGDs)

  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)

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

Study Arms (2)

Intervention group (group 1)

EXPERIMENTAL

Participants will retrieve individually administered BBTI by therapists through face-to-face meetings and phone-calls. Treatment will take 4 weeks.

Behavioral: Brief Behavioral Therapy for Insomnia

Active control group (group 2)

SHAM COMPARATOR

Participants will receive access to sleep hygiene education (SHE) through written educational material. Treatment will take 4 weeks.

Behavioral: Sleep Hygiene Therapy

Interventions

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.

Also known as: BBTI

Intervention group (group 1)

Sleep Hygiene Therapy BEHAVIORAL

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

Active control group (group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University

Aarhus, Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Alexander D Castro-Pavlik, PhD-student, MSc in Psychology

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander D Castro-Pavlik, PhD Student, MSc in Psychology

CONTACT

+4529122219; acp@psy.au.dk

Ali Amidi, Associate Professor

CONTACT

+4587165305; ali@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: We aim to mask the participants as much as possible. The study uses a single-blind randomized controlled design, in which participants will know what treatment they will receive and that there are two groups. However, they will not know what treatment the other group will receive or that one group is the intervention group and the other an active control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with two arms. Participants are randomized to either an intervention group receiving BBTI or an an intervention group receiving sleep hygiene. The sleep hygiene group functions as an active control group, as sleep hygiene is not expected to improve sleep.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results and continuing for 5 years thereafter.
• Access Criteria: Data will be made available to qualified researchers upon reasonable request to the study investigators, subject to approval and in accordance with applicable ethical and legal requirements.

Locations

DK (1)