Internet-CBT for Insomnia (IpsyInsomni)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Viktor Kaldo, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01256099
First received: October 12, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Insomnia
Depression
Behavioral: Therapist guided Internet-CBT for insomnia
Behavioral: Brief Internet-CBT for insomnia, without support
Behavioral: Therapist Guided Internet-CBT for depression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Insomnia Severity Index (ISI) [ Time Frame: Post-treatment (9 weeks) ] [ Designated as safety issue: No ]
    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.

  • MADRS-S [ Time Frame: Post-treatment (9 weeks) ] [ Designated as safety issue: Yes ]

    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.


  • ISI [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
  • ISI [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
  • ISI [ Time Frame: 3-years follow-up ] [ Designated as safety issue: No ]
  • MADRS-S [ Time Frame: 6-month follow-up ] [ Designated as safety issue: Yes ]
  • MADRS-S [ Time Frame: 1-year follow-up ] [ Designated as safety issue: Yes ]
  • MADRS-S [ Time Frame: 3-years follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sleep Diary [ Time Frame: Same as primary outcomes ] [ Designated as safety issue: No ]
    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) [ Time Frame: Same as Primary outcomes ] [ Designated as safety issue: No ]

    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 [ Time Frame: Same as primary outcomes ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 250
Study Start Date: January 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guided Internet-CBT for insomnia Behavioral: Therapist guided Internet-CBT for insomnia
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
Placebo Comparator: Control treatment Behavioral: Brief Internet-CBT for insomnia, without support
No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms
Experimental: Guided Internet-CBT for insomnia (9)
(9 weeks instead of 8)
Behavioral: Therapist guided Internet-CBT for insomnia
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
Active Comparator: Guided Internet-CBT for depression Behavioral: Therapist Guided Internet-CBT for depression
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256099

Locations
Sweden
Karolinska Institutet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
  More Information

Additional Information:
No publications provided

Responsible Party: Viktor Kaldo, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01256099     History of Changes
Other Study ID Numbers: 2009/1810-31/3
Study First Received: October 12, 2010
Last Updated: May 15, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Self-help treatment
Internet treatment
CBT
Prevention
Comorbidity

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014