Sleep Therapy for People with Prolonged Grief Disorder and Insomnia Disorder

Sleep Therapy for People with Prolonged Grief Disorder and Insomnia Disorder - Sleep Therapy in PGD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57646

Enrollment

Registered

2025-06-11

Start date

2026-08-10

Completion date

Unknown

Last updated

2026-08-24

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

Conditions

Prolonged Grief Disorder

Interventions

We will provide all participants with CBT-I, the first choice treatment for insomnia (Riemann et al., 2023). CBT-I consists of 6-7 weekly individual, face-to-face sessions of 1-2 hours according to

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The main inclusion criteria are: 1) meeting the diagnostic criteria for insomnia disorder 2) meeting the diagnostic criteria for prolonged grief disorder 3) 18 years or older

Exclusion criteria

Exclusion criteria: The main exclusion criteria are: 1) being diagnosed with, but not yet treated for a different sleep disorder 2) Using sleep medication or off-label use of sedative medication for insomnia symptoms for less than 3 months 3) Doing shiftwork, 4) Having traveled across time zones during the last week (>4 hours difference) 5) Being diagnosed with a schizophrenia spectrum disorder, a substance use disorder, being suicidal or mental retardation

Design outcomes

Primary

Measure	Time frame
The primary aim is to assess the effect of CBT-I on prolonged grief symptoms. To assess this effect, prolonged grief symptoms will be measured weekly for a period of 26 weeks starting parallel to the waiting period and continuing through the treatment phase. The mean difference in symptom levels between the baseline phase (waiting period) and treatment phase will serve as the primary outcome.	—

Secondary

Measure	Time frame
The secondary aim is to assess the effect of CBT-I on insomnia symptoms in people with prolonged grief disorder. The analysis of the insomnia symptoms will be identical to the analysis of prolonged grief symptoms. Besides primary and secondary outcome measures, inclusion and exclusion criteria will be assessed next to sociodemographic and loss-related characteristics (age, gender, education level, kinship to the deceased, gender of the deceased, cause of death, expectedness of the loss).	—

Measure

Time frame

The secondary aim is to assess the effect of CBT-I on insomnia symptoms in people with prolonged grief disorder. The analysis of the insomnia symptoms will be identical to the analysis of prolonged grief symptoms. Besides primary and secondary outcome measures, inclusion and exclusion criteria will be assessed next to sociodemographic and loss-related characteristics (age, gender, education level, kinship to the deceased, gender of the deceased, cause of death, expectedness of the loss).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Sep 19, 2026