NCT01105052

Brief Summary

The purpose of this study is to investigate whether a self-help book for insomnia, with or without therapist support, can improve sleep and alleviate insomnia symptoms in individuals suffering from insomnia, also for persons presenting with different kinds of co-morbid problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
Last Updated

April 16, 2010

Status Verified

April 1, 2010

Enrollment Period

11 months

First QC Date

April 12, 2010

Last Update Submit

April 14, 2010

Conditions

Insomnia

Keywords

InsomniaCo-morbidCBTSelf-helpBibliotherapy

Outcome Measures

Primary Outcomes (3)

  • Sleep diary

    Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress.

    Six weeks after beginning of treatment

  • Sleep diary

    Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress.

    5 months after beginning of treatment (i.e. about three months after the end of treatment)

  • Sleep diary

    Daily self-observation of sleeping behaviours used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and gagues Sleep Quality, Daytime Ratings, Daytime Fatique and Bedtime Stress.

    15 months after the end of treatment

Secondary Outcomes (3)

  • Insomnia Severity Index

    Six weeks after beginning of treatment

  • Insomnia Severity Index

    5 months after beginning of treatment (i.e. about three months after the end of treatment)

  • Insomnia Severity Index

    15 months after the end of treatment

Study Arms (3)

Bibliotherapy

ACTIVE COMPARATOR

A group receiving a self-help book to work on for six weeks with no therapist support.

Behavioral: Self-help CBT-I

Bibliotherapy with support

EXPERIMENTAL

A group receiving a self-help book to work on for six weeks, together with brief weekly telephone calls (\<15 minutes) from a therapist.

Behavioral: Self-help CBT-I

Wait-list control group

NO INTERVENTION

This group receives no intervention until about five months after the two treatment groups, when participants in this group receive the self-help book without therapist support.

Interventions

Self-help CBT-IBEHAVIORAL

Comparison between Bibliotherapy with and without support to a wait-list control group

BibliotherapyBibliotherapy with support

Eligibility Criteria

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

You may qualify if:

  • Age 18 and above
  • Diagnosis of Insomnia (Research Diagnostic Criteria)
  • Access to computer
  • Ability to read and write Swedish

You may not qualify if:

  • Severe psychopathology (e.g. bipolar disorder, suicidality)
  • Shift work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

Related Publications (2)

  • Kraepelien M, Blom K, Forsell E, Hentati Isacsson N, Bjurner P, Morin CM, Jernelov S, Kaldo V. A very brief self-report scale for measuring insomnia severity using two items from the Insomnia Severity Index - development and validation in a clinical population. Sleep Med. 2021 May;81:365-374. doi: 10.1016/j.sleep.2021.03.003. Epub 2021 Mar 16.

    PMID: 33813233DERIVED

  • Jernelov S, Lekander M, Blom K, Rydh S, Ljotsson B, Axelsson J, Kaldo V. Efficacy of a behavioral self-help treatment with or without therapist guidance for co-morbid and primary insomnia--a randomized controlled trial. BMC Psychiatry. 2012 Jan 22;12:5. doi: 10.1186/1471-244X-12-5.

    PMID: 22264332DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Mats Lekander, Ass prof

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 16, 2010

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

December 1, 2009

Last Updated

April 16, 2010

Record last verified: 2010-04

Locations

SE(1)