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

NCT ID: NCT07167706

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2027-05-31

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.

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.

Conditions

Insomnia; Insomnia Chronic; Complicated Grief

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group (group 1)

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

Group Type: EXPERIMENTAL

Brief Behavioral Therapy for Insomnia

Intervention Type: 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.

Active control group (group 2)

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

Group Type: SHAM_COMPARATOR

Sleep Hygiene Therapy

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Sleep Hygiene Therapy

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

Intervention Type: BEHAVIORAL

Other Intervention Names

BBTI

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Aarhus University

Aarhus, Jutland, Denmark

Countries

Denmark

Central Contacts

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

Role: CONTACT

acp@psy.au.dk

+4529122219

Ali Amidi, Associate Professor

Role: CONTACT

ali@psy.au.dk

+4587165305

Facility Contacts

Ali Amidi, Associate Professor

Role: primary

ali@psy.au.dk

+4587165305

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

Role: backup

acp@psy.au.dk

+4529122219

Other Identifiers

116242

Identifier Type: -

Identifier Source: org_study_id