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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2022-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Insomnia Major Depression Minor Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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(Study 1) ICBT for insomnia and depression

Group Type EXPERIMENTAL

Therapist guided Internet-CBT for insomnia and depression

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Therapist Guided Internet-CBT for depression plus insomnia placebo

Intervention Type 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.

(Study 2) ICBT for insomnia with added support

Group Type EXPERIMENTAL

Therapist guided Internet-CBT for insomnia w. extra support

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Therapist guided Internet-CBT for insomnia

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No