HypochondriasisNCT00959452
Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007
A study testing Cognitive behavioural therapy in people with Hypochondriasis, run by University of Bergen at 1 site in Norway.
Trial summary
Research has shown that cognitive behavioural therapy is effective in treating hypochondria. However, no studies have examined the long term effect. The investigators have followed 56 patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a 10 year follow-up (Part I). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypochondriasis
- What is being tested?
- Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- Jan 1997to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilling ICD-10 criteria for hypochondriacal disorder
Who cannot join
- Unwillingness to participate
- Substance abuse
- Serious psychological (f.inst. psychosis, major depression) or somatic (f.inst. cancer) disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow up of Patients Treated With Cognitive Behavioural Therapy at Clinic for Hypochondriacs, Haraldsplass Deaconal Hospital, From 1997 to 2007
Research has shown that cognitive behavioural therapy is effective in treating hypochondria. However, no studies have examined the long term effect. The investigators have followed 56 patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a 10 year follow-up (Part I). In another part of the study (Part II) the investigators compare the effect of 16 sessions vs. 5 sessions, with a follow-up period of at least 2 years. The investigators hypothesis is that the initial 1 year improvement will be sustained and that 5 sessions will yield the same results as 16 sessions.
Read the detailed description
The follow-up includes a telephone interview by independent researcher and the patients fill in the following questionnaires:
Whiteley Index (measures health anxiety), VAS-scales for health anxiety, worrying about symptoms and body checking, SF-36 (health related quality of life), Giessen Subjective Complaints List, Spielberger Trait and State Anxiety Scale Beck Depression Inventory, Eysenck Personality Questionnaire, General Health Questionnaire (GHQ 28), Somatic Amplification Scale,
- Conditions
- Hypochondriasis
- Being tested
- Cognitive behavioural therapy
- Keywords
- Hypochondria, Cognitive behavioural therapy, Long term follow-up, Psychosomatics, Psychotherapy
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapyBehavioural
Also called Cognitive therapy
16 sessions vs 5 sessions of cognitive behavioural therapy
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Not described Receives: Behavioral: Cognitive behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of health anxiety
Measured: 10 years follow up
Secondary outcomes (1)
Health related quality of life
Measured: 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJan 1997
- Primary completionDec 2010
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypochondriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingvard Wilhelmsen, University of Bergen
- Investigators
- Ingvard Wilhelmsen, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959452
- Sponsor's protocol ID
- 17242
- Status last verified
- Nov 2023
- First submitted
- 13 Aug 2009
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Veddegjaerde KE, Sivertsen B, Wilhelmsen I, Skogen JC. Confirmatory factor analysis and item response theory analysis of the Whiteley Index. Results from a large population based study in Norway. The Hordaland Health Study (HUSK). J Psychosom Res. 2014 Sep;77(3):213-8. doi: 10.1016/j.jpsychores.2014.06.011. Epub 2014 Jun 28.
PubMed 25149031Veddegjaerde KF, Sivertsen B, Skogen JC, Smith ORF, Wilhelmsen I. Long-term effect of cognitive-behavioural therapy in patients with Hypochondriacal Disorder. BJPsych Open. 2020 Apr 29;6(3):e42. doi: 10.1192/bjo.2020.22.
PubMed 32345417
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Patients Treated With Cognitive Behavioural Therapy at Clinic for Hypochondriacs, Haraldsplass Deaconal Hospital, From 1997 to 2007
- ClinicalTrials.gov ID
- NCT00959452
- Acronym / sponsor ID
- 17242
- Conditions
- Hypochondriasis
- Keywords
- Hypochondria, Cognitive behavioural therapy, Long term follow-up, Psychosomatics, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research has shown that cognitive behavioural therapy is effective in treating hypochondria. However, no studies have examined the long term effect. The investigators have followed 56 patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a 10 year follow-up (Part I). In another part of the study (Part II) the investigators compare the effect of 16 sessions vs. 5 sessions, with a follow-up period of at least 2 years. The investigators hypothesis is that the initial 1 year improvement will be sustained and that 5 sessions will yield the same results as 16 sessions.
Detailed description
The follow-up includes a telephone interview by independent researcher and the patients fill in the following questionnaires:
Whiteley Index (measures health anxiety), VAS-scales for health anxiety, worrying about symptoms and body checking, SF-36 (health related quality of life), Giessen Subjective Complaints List, Spielberger Trait and State Anxiety Scale Beck Depression Inventory, Eysenck Personality Questionnaire, General Health Questionnaire (GHQ 28), Somatic Amplification Scale,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: Cognitive behavioural therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fulfilling ICD-10 criteria for hypochondriacal disorder
Key exclusion criteria (3 listed)
- Unwillingness to participate
- Substance abuse
- Serious psychological (f.inst. psychosis, major depression) or somatic (f.inst. cancer) disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapyAlso: Cognitive therapy16 sessions vs 5 sessions of cognitive behavioural therapy | Behavioural | Psychotherapy |
Primary outcome
Level of health anxiety
Time frame: 10 years follow up
1 secondary outcome
Health related quality of life
Time frame: 10 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Results publication: PubMed 25149031Veddegjaerde KE, Sivertsen B, Wilhelmsen I, Skogen JC. Confirmatory factor analysis and item response theory analysis of the Whiteley Index. Results from a large population based study in Norway. The Hordaland Health Study (HUSK). J Psychosom Res. 2014 Sep;77(3):213-8. doi: 10.1016/j.jpsychores.2014.06.011. Epub 2014 Jun 28.
- Results publication: PubMed 32345417Veddegjaerde KF, Sivertsen B, Skogen JC, Smith ORF, Wilhelmsen I. Long-term effect of cognitive-behavioural therapy in patients with Hypochondriacal Disorder. BJPsych Open. 2020 Apr 29;6(3):e42. doi: 10.1192/bjo.2020.22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingvard Wilhelmsen, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy in people with Hypochondriasis, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of health anxiety (time frame: 10 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959452, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.