An interventional study of Therapist guided Internet-CBT for insomnia w. extra support and Therapist guided Internet-CBT for insomnia in Insomnia, Major Depression and Minor Depression, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 440 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
Behavioral: Therapist guided Internet-CBT for insomnia and depression
Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo
Behavioral: Therapist guided Internet-CBT for insomnia w. extra 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 plus extra therapist 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. Regular therapist support.
(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.
(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.
Change (from baseline) in Insomnia Severity Index (ISI)
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.
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
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.
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Sleep Diary
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.
Time frame: Directly after treatment
Changes (from baseline) in Actigraph data
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.
Time frame: Directly post treatment
Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
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
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Cognitive functioning
Computer based testing of executive functions, concentration, speed and memory.
Time frame: Directly at post-treatment
Change (from baseline) in EuroQuol. EQ-5D
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.
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Sheehan Disability Scale
Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM
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.
Time frame: 0, 6 and 36 months after treatment
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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