Internet-CBT for Insomnia

NCT01256099 | Completed

• 1 other identifier: 2009/1810-31/3
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Depression

Keywords

Self-help treatment; Internet treatment; CBT; Prevention; Comorbidity

Outcome Measures

Primary Outcomes (8)

• Insomnia Severity Index (ISI)

  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.

  Post-treatment (9 weeks)

• MADRS-S

  The use of two primary outcomes are motivated since the purpose is to look at effects on both insomnia and depression. In trial 1 the former is used to predict the latter, and in Trial 2 the patientents suffer from both conditions. The MADRS-S is a 9-item self-rated measure of depression severity and screens for suicidality. Mattila-Evenden, M., Svanborg, P., Gustavsson, P., \& Åsberg, M. (1996). Determinants of self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of CPRS. Acta Psychiatr Scand, 94, 386-396.

  Post-treatment (9 weeks)

• ISI

  6-month follow-up

• ISI

  1-year follow-up

• ISI

  3-years follow-up

• MADRS-S

  6-month follow-up

• MADRS-S

  1-year follow-up

• MADRS-S

  3-years follow-up

Secondary Outcomes (3)

• Sleep Diary

  Same as primary outcomes

• Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)

  Same as Primary outcomes

• EQ-5D

  Same as primary outcomes

Study Arms (4)

Guided Internet-CBT for insomnia

EXPERIMENTAL

Behavioral: Therapist guided Internet-CBT for insomnia

Control treatment

PLACEBO COMPARATOR

Behavioral: Brief Internet-CBT for insomnia, without support

Guided Internet-CBT for insomnia (9)

EXPERIMENTAL

(9 weeks instead of 8)

Behavioral: Therapist guided Internet-CBT for insomnia

Guided Internet-CBT for depression

ACTIVE COMPARATOR

Behavioral: Therapist Guided Internet-CBT for depression

Interventions

Therapist guided Internet-CBT for insomnia BEHAVIORAL

An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia

Guided Internet-CBT for insomnia; Guided Internet-CBT for insomnia (9)

Brief Internet-CBT for insomnia, without support BEHAVIORAL

No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms

Control treatment

Therapist Guided Internet-CBT for depression BEHAVIORAL

An 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed

Guided Internet-CBT for depression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (4)

• 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: 33813233 DERIVED

• Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up Comparing Cognitive Behavioral Therapy for Depression to Cognitive Behavioral Therapy for Insomnia, for Patients With Both Diagnoses. Sleep. 2017 Aug 1;40(8). doi: 10.1093/sleep/zsx108.

  PMID: 28655183 DERIVED

• Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up of Insomnia and Hypnotics after Controlled Internet Treatment for Insomnia. Sleep. 2016 Jun 1;39(6):1267-74. doi: 10.5665/sleep.5850.

  PMID: 27091535 DERIVED

• Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412.

  PMID: 25337948 DERIVED

Related Links

• The public page of the Internet-CBT treatment platform

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: December 8, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

SE (1)