Internet-CBT for Insomnia

Not Applicable

Completed

• Conditions: Insomnia; Depression
• Interventions: Behavioral: Brief Internet-CBT for insomnia, without support; Behavioral: Therapist Guided Internet-CBT for depression; Behavioral: Therapist guided Internet-CBT for insomnia

• Registration Number: NCT01256099
• Lead Sponsor: Karolinska Institutet

Brief Summary

This study includes two sub-trials.

In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.

Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.

Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Primary Completion: 2014-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

• Clinical level of Insomnia (more than 10 on ISI)
• Meets criteria for Insomnia according to DSM-IV-TR
• Enough language skills
• Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR

Exclusion Criteria

• Sleep disorders requiring other treatment
• High consumption of alcohol/drugs that affect sleep
• Started to use or changed the dose of antidepressant drug during the last 2 months
• Somatic or psychiatric conditions requiring acute care
• Working night shifts
• Only Trial 1: Meets criteria for Major Depressive Disorder according to DSM-IV-TR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control treatment	Brief Internet-CBT for insomnia, without support	-
Guided Internet-CBT for depression	Therapist Guided Internet-CBT for depression	-
Guided Internet-CBT for insomnia	Therapist guided Internet-CBT for insomnia	-
Guided Internet-CBT for insomnia (9)	Therapist guided Internet-CBT for insomnia	(9 weeks instead of 8)

Primary Outcome Measures

Name	Time	Method
ISI	3-years follow-up
MADRS-S	3-years follow-up
Insomnia Severity Index (ISI)	Post-treatment (9 weeks)	7-item, self-rated questionnaire measuring insomnia severity. Bastien, C. H., Vallières, A., \& Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.

Secondary Outcome Measures

Name	Time	Method
Sleep Diary	Same as primary outcomes	One week of self-ratings on a number of sleep parameters, resluting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjecitve sleep quality and daytime functioning
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	Same as Primary outcomes	Health economic questionnaire evalutation cost for health care, abscence of work capacity and related costs.; Hakkaart-Van Roijen, L.,Van Straten, A., \& Donker, M. (2002). Manual: Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness. Rotterdam: Erasmus University
EQ-5D	Same as primary outcomes	General quality of life measure to complement the TIC-P in health economic analysis.; Hinz, A., Klaiberg, A., Brahler, E., \& Konig, H.H. (2006). The Quality of Life Questionnaire EQ-5D: modelling and norm values for the general population. Psychother.Psychosom.Med.Psychol., 56, 42-48.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden