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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Insomnia
Major Depression
Minor Depression
Behavioral: Therapist guided Internet-CBT for insomnia w. extra support
Behavioral: Therapist guided Internet-CBT for insomnia
Behavioral: Therapist guided Internet-CBT for insomnia and depression
Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 440
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (Study 1) ICBT for insomnia and depression 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.
Active Comparator: (Study 1) ICBT for depr. plus placebo insomnia intervention 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 2) ICBT for insomnia with added support 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.
Active Comparator: (Study 2) ICBT for insomnia with regular level of 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.

  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 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).
  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: NCT01663844

Contacts
Contact: Viktor Kaldo, PhD +46707373859 viktor.kaldo@ki.se
Contact: Kerstin Blom, MSc +46701655228 kerstin.blom@sll.se

Locations
Sweden
Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO Recruiting
Stockholm, Sweden, S-14186
Contact: Kaldo    +46 +46707373859    viktor.kaldo@ki.se   
Principal Investigator: Viktor Kaldo, PhD         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Viktor Kaldo, PhD Karolinska Institutet
  More Information

Additional Information:
No publications provided

Responsible Party: Viktor Kaldo, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01663844     History of Changes
Other Study ID Numbers: 2012/934-31/4
Study First Received: August 3, 2012
Last Updated: May 15, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Cognitive behavior therapy
Internet treatment
Self-help treatment
Insomnia
Depression
ICBT
CBT-i
CBT-d

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
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 28, 2014