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

Insomnia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Major Depression

Minor Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

(Study 1) ICBT for insomnia and depression

(Study 1) ICBT for depr. plus placebo insomnia intervention

(Study 2) ICBT for insomnia with added support

(Study 2) ICBT for insomnia with regular level of support

Study Status

Unknown status

Start Date: January 2013

Completed Date: September 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change (from baseline) in Insomnia Severity Index (ISI)

Secondary Outcome: Change (from baseline) in Sleep Diary

Study sponsors, principal investigator, and references

Principal Investigator: Viktor Kaldo, PhD

Lead Sponsor: Karolinska Institutet

Collaborator: Stockholm County Council, Sweden

More information:https://clinicaltrials.gov/show/NCT01663844

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