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

Not Applicable

Completed

• Conditions: Major Depression; Insomnia; Minor Depression
• Interventions: 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

• Registration Number: NCT01663844
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-13
• Study Start: 2013-01
• Primary Completion: 2018-12
• Study Completion: 2022-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Study 1) ICBT for insomnia and depression	Therapist guided Internet-CBT for insomnia and depression	-
(Study 1) ICBT for depr. plus placebo insomnia intervention	Therapist Guided Internet-CBT for depression plus insomnia placebo	-
(Study 2) ICBT for insomnia with added support	Therapist guided Internet-CBT for insomnia w. extra support	-
(Study 2) ICBT for insomnia with regular level of support	Therapist guided Internet-CBT for insomnia	-

Primary Outcome Measures

Name	Time	Method
Change (from baseline) in Insomnia Severity Index (ISI)	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.
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S	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 Outcome Measures

Name	Time	Method
Change (from baseline) in Sleep Diary	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.
Change (from baseline) in Cognitive functioning	Directly at post-treatment	Computer based testing of executive functions, concentration, speed and memory.
Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	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
Change (from baseline) in Sheehan Disability Scale	0, 6 and 36 months after treatment	Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York
Changes (from baseline) in Actigraph data	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.
Change (from baseline) in EuroQuol. EQ-5D	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.
Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM	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.

Trial Locations

Locations (1)

Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO; 🇸🇪 Stockholm, Sweden