Internet-based Cognitive Behavior Therapy for Insomnia for Parents Who Have Lost a Child

Therapist Guided Internet Cognitive Behavioral Therapy (ICBT) for Insomnia for Bereaved Parents: a Randomized Controlled Trial (RCT)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02886052

Enrollment

Registered

2016-09-01

Start date

2016-09-30

Completion date

2018-12-31

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bereavement, Insomnia

Keywords

Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, ICBT, CBT-i, Bereavement

Brief summary

The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to evaluate changes in symptoms of complicated grief and depression.

Interventions

BEHAVIORALTherapist guided Internet-CBT for insomnia

OTHERActive control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Clinical level of Insomnia (more than 10 on ISI) * Meets criteria for Insomnia according to DSM-5 * Enough Swedish language skills

Exclusion criteria

* Other sleep disorders that require other treatment (e.g. sleep apnea) * Somatic or psychiatric conditions requiring acute care

Design outcomes

Primary

Measure	Time frame	Description
Change (from baseline) in Insomnia Severity Index, ISI	0, 9 and 18 months after treatment	7-item, self-rated questionnaire measuring change in insomnia severity.

Secondary

Measure	Time frame	Description
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S	0, 9 and 18 months after treatment	The MADRS-S is a 9-item self-rated measure of change in depression severity.
Change (from baseline) in Prolonged Grief Disorder, PG-13	0, 9 and 18 months after treatment	13-item, self-rated measure of prolonged grief disorder
Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5	0, 9 and 18 months after treatment	20-item, self-rated measure of posttraumatic stress disorder
Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7	0, 9 and 18 months after treatment	7-item, self-rated measure of anxiety symptoms
Change (from baseline) in Utrecht Grief Rumination Scale, UGRS	0, 9 and 18 months after treatment	15-item, self-rated measure of grief rumination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026