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

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.

Conditions

• Insomnia
• Major Depression
• Minor Depression

Interventions

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.

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Viktor Kaldo, PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2018-12-31

Completion

2022-05-31

Countries

• Sweden

Study Locations