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CompletedNCT01731223Sleep PrimeUpdated Aug 8, 2018

Group Treatment for Insomnia in Primary Health Care

An interventional study of Group treatment for insomnia in Insomnia, sponsored by Jeanette Westman. Completed at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Jeanette Westman · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to analyze if group treatment is effective to treat insomnia in primary healthcare.

Read the detailed description

Insomnia is a common health problem. Untreated insomnia may lead to decreased physical and mental health. The patients turns to Primary Health Care when daytime symptoms decrease social and occupational function. Previous studies have shown that cognitive and behavioral therapy have effects on insomnia and recommends as first line treatment but is not widely available in primary health care.

The purpose is to test the effect of group intervention in Primary Health Care for patients with insomnia. The outcomes is insomnia severity, sleep habits, use of hypnotics, Fatigue, general health and health related quality of life. Characters with insomnia visiting in Primary Health Care.

02

Conditions studied

  • Insomnia

Keywords

  • Insomnia
  • Primary health care
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 165 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

This is the only study on the registry with Jeanette Westman as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Insomnia symptoms regarding DSM-V
  • Motivated to group treatment.

Exclusion criteria

Exclusion Criteria:

  • Insomnia Severity Index less than 7 points
  • Presence of acute life crises, acute psychiatric illness, bipolar disorder
  • Shift work
  • Linguistic or cognitive difficulties causing inability participate in group or fill in forms
  • Insomnia directly caused by medical illness. Other sleep disorder.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    Group treatment for insomnia

    Group treatment for insomnia.

    Behavioral: Group treatment for insomnia

  • No intervention
    No intervention

    Treatment as usual

Interventions

  • BehavioralGroup treatment for insomnia

    Experimental: Group treatment of insomnia The intervention is a group treatment based on cognitive and behavioral changing methods. It is including seven sessions during 10 weeks. Each session last for 2 hours with a 20 minutes pause. The intervention includes psycho education about sleep. Methods as relaxation, coping with worry, sleep restriction, stimulus control, sleep hygiene, stress coping strategies, strategies for coping with daytime symptom, identify and reformulate negative and dysfunctional thoughts about sleep, daytime functioning and stress and strategies for reducing hypnotics.

06

What researchers measure

Primary outcomes

  1. Insomnia severity Index

    Insomnia Severity Index (ISI)is a seven item self assessment scale measuring severity of insomnia symptoms during the last two weeks. The items asks about sleep disturbance, daytime functioning and worrying about sleep. The possibly response is 0 "None" 1 "Mild" 2 "Moderate" 3 "Severe" 4 "Very severe". The sum is added and 0-7 p grades the insomnia to "none clinically significant insomnia", 8-14 p "subtreshold insomnia", 15-21 p "moderate insomnia", 22-28 p "severe insomnia".

    Time frame: One year

Secondary outcomes

  1. Fatigue severity scale

    Measures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points

    Time frame: one year

Other outcomes

  1. Sleep Logg

    Sleep log for every night during two weeks. The patient logs time going to bed, sleep latency, awakes during the night, time going up from bed in the morning, total sleep time, sleep quality graded from 1-5. ! is very bad and 5 is very good). Use of alcohol, hypnotics and herbs are noted

    Time frame: one year

07

Study locations

2 sites
  • Centre for family medicine
    Stockholm, Huddinge 14183, Sweden
  • Centrum för allmanmedicin
    Stockholm, Huddinge 14183, Sweden
08

References and documents

Publications

  • LeBlanc M, Beaulieu-Bonneau S, Merette C, Savard J, Ivers H, Morin CM. Psychological and health-related quality of life factors associated with insomnia in a population-based sample. J Psychosom Res. 2007 Aug;63(2):157-66. doi: 10.1016/j.jpsychores.2007.03.004. PubMed 17662752 ↗
  • Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2. PubMed 20813762 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01731223
Lead sponsor
Jeanette Westman
Collaborators
Region Stockholm, Karolinska Institutet
Responsible party
Jeanette Westman (PhD, Karolinska Institutet) — Sponsor-investigator
First posted
Nov 21, 2012
Start date
Aug 2010
Primary completion
Jun 2015
Completion
Aug 2015
Last update
Aug 8, 2018

Study contacts

Jeanette Westman, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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