Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety (Ha1b)

May 5, 2015 updated by: Karolinska Institutet

Internet-delivered Cognitive Behavioural Therapy for Health Anxiety - a Randomized Controlled Trial

Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT) has proven to be effective when administered in live-sessions. The aim of this study is to investigate whether CBT remains effective when administered via a self-help programme on the Internet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Psykiatri Sydväst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary diagnosis of hypochondriasis
  • At least 18 years old
  • Able to read and write in swedish
  • Computer access

Exclusion Criteria:

  • Drug abuse
  • Concurrent severe depression
  • No serious somatic illness
  • Previous treatment with CBT for hypochondriasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks.
Behavioral: Internet-delivered CBT.
12 weeks. Therapist contact through e-mail.
Placebo Comparator: 2
On line discussion group.
Behavioral: On line discussion group
Placebo. On line discussion group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health Anxiety Inventory
Time Frame: 3 days before treatment start
3 days before treatment start
Health Anxiety Inventory
Time Frame: 12 weeks after pre asessment
12 weeks after pre asessment
Health Anxiety Inventory
Time Frame: 6 months after post assessment
6 months after post assessment
Health Anxiety Inventory
Time Frame: 12 months after post assessment
12 months after post assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
IAS
Time Frame: Immediately pre and post treatment,and 6 and 12 month follow up
Immediately pre and post treatment,and 6 and 12 month follow up
BAI
Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up
Immediately pre and post treatment, and 6 and 12 month follow-up
MADRS-S
Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up
Immediately pre and post treatment, and 6 and 12 month follow-up
QOLI
Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up
Immediately pre and post treatment, and 6 and 12 month follow-up
WI
Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up
Immediately pre and post treatment, and 6 and 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ha1b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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