NCT00828152

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 6, 2015

Status Verified

June 1, 2010

Enrollment Period

1.4 years

First QC Date

January 22, 2009

Last Update Submit

May 5, 2015

Conditions

Hypochondriasis

Outcome Measures

Primary Outcomes (4)

  • Health Anxiety Inventory

    3 days before treatment start

  • Health Anxiety Inventory

    12 weeks after pre asessment

  • Health Anxiety Inventory

    6 months after post assessment

  • Health Anxiety Inventory

    12 months after post assessment

Secondary Outcomes (5)

  • IAS

    Immediately pre and post treatment,and 6 and 12 month follow up

  • BAI

    Immediately pre and post treatment, and 6 and 12 month follow-up

  • MADRS-S

    Immediately pre and post treatment, and 6 and 12 month follow-up

  • QOLI

    Immediately pre and post treatment, and 6 and 12 month follow-up

  • WI

    Immediately pre and post treatment, and 6 and 12 month follow-up

Study Arms (2)

1

EXPERIMENTAL

Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks.

Behavioral: Internet-delivered CBT.

2

PLACEBO COMPARATOR

On line discussion group.

Behavioral: On line discussion group

Interventions

Internet-delivered CBT.BEHAVIORAL

12 weeks. Therapist contact through e-mail.

1
On line discussion groupBEHAVIORAL

Placebo. On line discussion group.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatri Sydväst

Stockholm, Stockholm County, 141 86, Sweden

Location

Related Publications (3)

  • Hedman E, Andersson G, Lindefors N, Gustavsson P, Lekander M, Ruck C, Andersson E, Ljotsson B. Personality change following internet-based cognitive behavior therapy for severe health anxiety. PLoS One. 2014 Dec 1;9(12):e113871. doi: 10.1371/journal.pone.0113871. eCollection 2014.

    PMID: 25437150DERIVED

  • Hedman E, Andersson E, Lindefors N, Andersson G, Ruck C, Ljotsson B. Cost-effectiveness and long-term effectiveness of internet-based cognitive behaviour therapy for severe health anxiety. Psychol Med. 2013 Feb;43(2):363-74. doi: 10.1017/S0033291712001079. Epub 2012 May 21.

    PMID: 22608115DERIVED

  • Hedman E, Andersson G, Andersson E, Ljotsson B, Ruck C, Asmundson GJ, Lindefors N. Internet-based cognitive-behavioural therapy for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2011 Mar;198(3):230-6. doi: 10.1192/bjp.bp.110.086843.

    PMID: 21357882DERIVED

MeSH Terms

Conditions

Hypochondriasis

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

May 6, 2015

Record last verified: 2010-06

Locations

SE(1)