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

University of Aarhus

Status: Not yet enrolling

Conditions: Insomnia; Complicated Grief; Insomnia Chronic

Treatments: Behavioral: Brief Behavioral Therapy for Insomnia; Behavioral: Sleep Hygiene Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07167706

116242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Intervention group (group 1)

Experimental group

Description:

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

Treatment:

Behavioral: Brief Behavioral Therapy for Insomnia

Active control group (group 2)

Sham Comparator group

Description:

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

Treatment:

Behavioral: Sleep Hygiene Therapy