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

October 12, 2010
May 15, 2014
January 2010
February 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01256099 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
Internet-CBT for Insomnia
Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Insomnia
  • Depression
  • 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
  • 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
  • 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
  • Experimental: Guided Internet-CBT for insomnia
    Intervention: Behavioral: Therapist guided Internet-CBT for insomnia
  • Placebo Comparator: Control treatment
    Intervention: Behavioral: Brief Internet-CBT for insomnia, without support
  • Experimental: Guided Internet-CBT for insomnia (9)
    (9 weeks instead of 8)
    Intervention: Behavioral: Therapist guided Internet-CBT for insomnia
  • Active Comparator: Guided Internet-CBT for depression
    Intervention: Behavioral: Therapist Guided Internet-CBT for depression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01256099
2009/1810-31/3
No
Viktor Kaldo, Karolinska Institutet
Karolinska Institutet
Stockholm County Council, Sweden
Not Provided
Karolinska Institutet
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP