New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression

This study is currently recruiting participants.
Verified January 2013 by Karolinska Institutet
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Viktor Kaldo, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01663844
First received: August 3, 2012
Last updated: January 16, 2013
Last verified: January 2013

August 3, 2012
January 16, 2013
January 2013
September 2014   (final data collection date for primary outcome measure)
  • Change (from baseline) in Insomnia Severity Index (ISI) [ Time Frame: 0, 6 and 36 months after treatment ] [ Designated as safety issue: No ]
    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.
  • Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S [ Time Frame: 0, 6 and 36 months after treatment ] [ Designated as safety issue: No ]

    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., & 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.

Same as current
Complete list of historical versions of study NCT01663844 on ClinicalTrials.gov Archive Site
  • Change (from baseline) in Sleep Diary [ Time Frame: Directly after treatment ] [ Designated as safety issue: No ]
    One week of self-ratings on a number of sleep parameters, resulting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjective sleep quality and daytime functioning.
  • Changes (from baseline) in Actigraph data [ Time Frame: Directly post treatment ] [ Designated as safety issue: No ]
    An actigraph is placed on the participant's arm for one week. They measure participants' activity in the form of movements. It will be used for acquiring sleep data and calculate sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings and daytime activity.
  • Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: 0, 6 and 36 months after treatment ] [ Designated as safety issue: No ]

    Health economic questionnaire evaluation cost for health care, absence 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

  • Change (from baseline) in Cognitive functioning [ Time Frame: Directly at post-treatment ] [ Designated as safety issue: No ]
    Computer based testing of executive functions, concentration, speed and memory.
  • Change (from baseline) in EuroQuol. EQ-5D [ Time Frame: 0, 6 and 36 months after treatment ] [ 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.

  • Change (from baseline) in Sheehan Disability Scale [ Time Frame: 0, 6 and 36 months after treatment ] [ Designated as safety issue: No ]
    Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York
  • Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM [ Time Frame: 0, 6 and 36 months after treatment ] [ Designated as safety issue: No ]
    Measures psychological health in general. Evans, C., Connell, J., Barkham, M., Margison, F., McGrath, G., Mellor-Clark, J. & Audin, K. (2002). Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. The British journal of psychiatry : the journal of mental science 180, 51-60.
Same as current
Not Provided
Not Provided
 
New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression
New Clinical Applications for Internet-based Cognitive Behavior Therapy: An Adaptive Treatment Strategy to Decrease the Number of Failed Treatments, and a Combination Treatment for Insomnia and Depression.

This study includes two sub-trials. Both are included in this singe registration since they have parrallel 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Insomnia
  • Major Depression
  • Minor Depression
  • Behavioral: Therapist guided Internet-CBT for insomnia w. extra support
    (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.
  • Behavioral: Therapist guided Internet-CBT for insomnia
    (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.
  • Behavioral: Therapist guided Internet-CBT for insomnia and depression
    (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.
  • Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo
    (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.
  • Experimental: (Study 1) ICBT for insomnia and depression
    Intervention: Behavioral: Therapist guided Internet-CBT for insomnia and depression
  • Active Comparator: (Study 1) ICBT for depr. plus placebo insomnia intervention
    Intervention: Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo
  • Experimental: (Study 2) ICBT for insomnia with added support
    Intervention: Behavioral: Therapist guided Internet-CBT for insomnia w. extra support
  • Active Comparator: (Study 2) ICBT for insomnia with regular level of support
    Intervention: Behavioral: Therapist guided Internet-CBT for insomnia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
September 2014
September 2014   (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 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).

Exclusion Criteria:

  • 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
  • Only Trial 2: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required for exclusion).
Both
18 Years and older
No
Contact: Viktor Kaldo, PhD +46707373859 viktor.kaldo@ki.se
Contact: Kerstin Blom, MSc +46701655228 kerstin.blom@sll.se
Sweden
 
NCT01663844
2012/934-31/4
No
Viktor Kaldo, Karolinska Institutet
Karolinska Institutet
Stockholm County Council, Sweden
Principal Investigator: Viktor Kaldo, PhD Karolinska Institutet
Karolinska Institutet
January 2013

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