NCT01731223

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

4.8 years

First QC Date

November 16, 2012

Last Update Submit

August 7, 2018

Conditions

Insomnia

Keywords

InsomniaPrimary health care

Outcome Measures

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".

    One year

Secondary Outcomes (1)

  • Fatigue severity scale

    one year

Other Outcomes (1)

  • Sleep Logg

    one year

Study Arms (2)

Group treatment for insomnia

EXPERIMENTAL

Group treatment for insomnia.

Behavioral: Group treatment for insomnia

No intervention

NO INTERVENTION

Treatment as usual

Interventions

Group treatment for insomniaBEHAVIORAL

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.

Group treatment for insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for family medicine

Stockholm, Huddinge, 14183, Sweden

Location

Centrum för allmanmedicin

Stockholm, Huddinge, 14183, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 17662752BACKGROUND

  • 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.

    PMID: 20813762BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jeanette Westman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 21, 2012

Study Start

August 1, 2010

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

SE(2)