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Completed

NCT Number: NCT01663844

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

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Dyssomnias Major Depression Mental Disorders Minor Depression Mood Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO

Stockholm, S-14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Therapist guided Internet-CBT for insomnia w. extra support

Behavioral

(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.

Therapist guided Internet-CBT for insomnia

Behavioral

(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.

Therapist guided Internet-CBT for insomnia and depression

Behavioral

(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.

Therapist Guided Internet-CBT for depression plus insomnia placebo

Behavioral

(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.

Primary outcomes

  1. Change (from baseline) in Insomnia Severity Index (ISI)

    Time frame: 0, 6 and 36 months after treatment

    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.

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

    Time frame: 0, 6 and 36 months after treatment

    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 outcomes

  1. Change (from baseline) in Sleep Diary

    Time frame: Directly after treatment

    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.

  2. Changes (from baseline) in Actigraph data

    Time frame: Directly post treatment

    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.

  3. 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

    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

  4. Change (from baseline) in Cognitive functioning

    Time frame: Directly at post-treatment

    Computer based testing of executive functions, concentration, speed and memory.

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

    Time frame: 0, 6 and 36 months after treatment

    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.

  6. Change (from baseline) in Sheehan Disability Scale

    Time frame: 0, 6 and 36 months after treatment

    Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York

  7. Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM

    Time frame: 0, 6 and 36 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2018
Study completion
2022
First posted
Aug 13, 2012
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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