NCT01663844

Brief Summary

This study includes two sub-trials. Both are included in this singe registration since they have parallel inclusion of participants and have been approved by the Swedish ethics board together in one application. Trial 1 includes patients with both insomnia and major or minor depression. Participants are randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment. Trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. The primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment. NOTE: The first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. These problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. The pilot participants will not be included in the main analyses of data. This was decided upon on 31st of October 2014.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 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

First Submitted

Initial submission to the registry

August 3, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

5.9 years

First QC Date

August 3, 2012

Last Update Submit

July 15, 2022

Conditions

InsomniaMajor DepressionMinor Depression

Keywords

Cognitive behavior therapyInternet treatmentSelf-help treatmentInsomniaDepressionICBTCBT-iCBT-d

Outcome Measures

Primary Outcomes (2)

  • Change (from baseline) in Insomnia Severity Index (ISI)

    7-item, self-rated questionnaire measuring change in 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.

    0, 6 and 36 months after treatment

  • Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S

    Defined as secondary outcome measure in Trial 2. The use of two primary outcomes in trial 1 is motivated since participants have both diagnoses and the purpose is to look at effects on both insomnia and depression. The MADRS-S is a 9-item self-rated measure of change in depression severity. It also screens for suicidality. Mattila-Evenden, M., Svanborg, P., Gustavsson, P., \& Ă…sberg, 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.

    0, 6 and 36 months after treatment

Secondary Outcomes (7)

  • Change (from baseline) in Sleep Diary

    Directly after treatment

  • Changes (from baseline) in Actigraph data

    Directly post treatment

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

    0, 6 and 36 months after treatment

  • Change (from baseline) in Cognitive functioning

    Directly at post-treatment

  • Change (from baseline) in EuroQuol. EQ-5D

    0, 6 and 36 months after treatment

  • +2 more secondary outcomes

Study Arms (4)

(Study 1) ICBT for insomnia and depression

EXPERIMENTAL
Behavioral: Therapist guided Internet-CBT for insomnia and depression

(Study 1) ICBT for depr. plus placebo insomnia intervention

ACTIVE COMPARATOR
Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo

(Study 2) ICBT for insomnia with added support

EXPERIMENTAL
Behavioral: Therapist guided Internet-CBT for insomnia w. extra support

(Study 2) ICBT for insomnia with regular level of support

ACTIVE COMPARATOR
Behavioral: Therapist guided Internet-CBT for insomnia

Interventions

Therapist guided Internet-CBT for insomnia w. extra supportBEHAVIORAL

(Study 2) A 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 insomnia plus extra therapist support.

(Study 2) ICBT for insomnia with added support
Therapist guided Internet-CBT for insomniaBEHAVIORAL

(Study 2) A 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 insomnia. Regular therapist support.

(Study 2) ICBT for insomnia with regular level of support
Therapist guided Internet-CBT for insomnia and depressionBEHAVIORAL

(Study 1) A 12 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 and depression.

(Study 1) ICBT for insomnia and depression
Therapist Guided Internet-CBT for depression plus insomnia placeboBEHAVIORAL

(Study 1) A 12 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. A placebo intervention for insomnia is added.

(Study 1) ICBT for depr. plus placebo insomnia intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 1: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of \>19 is required).

You may not qualify if:

  • Sleep disorders requiring other treatment
  • Alcohol/drugs abuse
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO

Stockholm, S-14186, Sweden

Location

Related Publications (3)

  • Tamm S, Jernelov S, Forsell E, Eldh A, Hallek de Oliveira A, Maurex L, Kaldo V, Blom K. Objectively measured cognitive function in insomnia patients with and without comorbid depression treated with cognitive behavioral therapy for insomnia. BMC Psychiatry. 2025 Oct 2;25(1):916. doi: 10.1186/s12888-025-07460-5.

    PMID: 41039374DERIVED

  • 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

  • Forsell E, Jernelov S, Blom K, Kraepelien M, Svanborg C, Andersson G, Lindefors N, Kaldo V. Proof of Concept for an Adaptive Treatment Strategy to Prevent Failures in Internet-Delivered CBT: A Single-Blind Randomized Clinical Trial With Insomnia Patients. Am J Psychiatry. 2019 Apr 1;176(4):315-323. doi: 10.1176/appi.ajp.2018.18060699. Epub 2019 Jan 30.

    PMID: 30696270DERIVED

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersDepressive DisorderMood DisordersBehavioral SymptomsBehavior

Study Officials

  • Viktor Kaldo, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 13, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

May 1, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations

SE(1)