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Group Treatment for Insomnia in Primary Health Care

Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01731223
Acronym
Sleep Prime
Enrollment
165
Registered
2012-11-21
Start date
2010-08-31
Completion date
2015-08-31
Last updated
2018-08-08

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

Conditions

Insomnia

Keywords

Insomnia, Primary health care

Brief summary

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

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.

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.

Sponsors

Region Stockholm
CollaboratorOTHER_GOV
Karolinska Institutet
CollaboratorOTHER
Jeanette Westman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Insomnia severity IndexOne yearInsomnia 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.

Secondary

MeasureTime frameDescription
Fatigue severity scaleone yearMeasures fatigue symptoms in a seven item self assessment scale. Response from 1-7 points

Other

MeasureTime frameDescription
Sleep Loggone yearSleep 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

Countries

Sweden

Outcome results

None listed

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