HypochondriasisPhase 2Ha1bNCT00828152
Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety
A Phase 2 study testing Internet-delivered CBT. and On line discussion group in people with Hypochondriasis, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypochondriasis
- What is being tested?
- Internet-delivered CBT. and On line discussion group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Jul 2010
- Phase
- Phase 2
- 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
- Primary diagnosis of hypochondriasis
- At least 18 years old
- Able to read and write in swedish
- Computer access
Who cannot join
- Drug abuse
- Concurrent severe depression
- No serious somatic illness
- Previous treatment with CBT for hypochondriasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypochondriasis
- Being tested
- Internet-delivered CBT., On line discussion group
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered CBT.Behavioural
12 weeks. Therapist contact through e-mail.
On line discussion groupBehavioural
Placebo. On line discussion group.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks. Receives: Behavioral: Internet-delivered CBT. |
| 2 | Placebo comparator | On line discussion group. Receives: Behavioral: On line discussion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Anxiety Inventory
Measured: 3 days before treatment start
Health Anxiety Inventory
Measured: 12 weeks after pre asessment
Health Anxiety Inventory
Measured: 6 months after post assessment
Health Anxiety Inventory
Measured: 12 months after post assessment
Secondary outcomes (5)
IAS
Measured: Immediately pre and post treatment,and 6 and 12 month follow up
BAI
Measured: Immediately pre and post treatment, and 6 and 12 month follow-up
MADRS-S
Measured: Immediately pre and post treatment, and 6 and 12 month follow-up
QOLI
Measured: Immediately pre and post treatment, and 6 and 12 month follow-up
WI
Measured: Immediately pre and post treatment, and 6 and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypochondriasisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828152
- Sponsor's protocol ID
- Ha1b
- Acronym
- Ha1b
- Status last verified
- Jun 2010
- First submitted
- 22 Jan 2009
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25437150Hedman 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.
PubMed 22608115Hedman 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.
PubMed 21357882
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavioural Therapy for Health Anxiety - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00828152
- Acronym / sponsor ID
- Ha1b / Ha1b
- Conditions
- Hypochondriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Internet-delivered CBT.Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks. |
| 2 | Placebo comparator | Behavioral: On line discussion groupOn line discussion group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary diagnosis of hypochondriasis
- At least 18 years old
- Able to read and write in swedish
- Computer access
Key exclusion criteria (4 listed)
- Drug abuse
- Concurrent severe depression
- No serious somatic illness
- Previous treatment with CBT for hypochondriasis
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 |
|---|---|---|
| Internet-delivered CBT.12 weeks. Therapist contact through e-mail. | Behavioural | 1 |
| On line discussion groupPlacebo. On line discussion group. | Behavioural | 2 |
Primary outcome
Health Anxiety Inventory
Time frame: 3 days before treatment start
Health Anxiety Inventory
Time frame: 12 weeks after pre asessment
Health Anxiety Inventory
Time frame: 6 months after post assessment
Health Anxiety Inventory
Time frame: 12 months after post assessment
5 secondary outcomes
IAS
Time frame: 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
MADRS-S
Time frame: 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
WI
Time frame: Immediately pre and post treatment, and 6 and 12 month 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 6 May 2015.
- Derived from this study: PubMed 25437150Hedman 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.
- Derived from this study: PubMed 22608115Hedman 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.
- Derived from this study: PubMed 21357882Hedman 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.
Related trials for Hypochondriasis
Active, not recruiting
Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
Anxiety Disorders, Obsessive-Compulsive Disorder
Recruiting
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
Panic Disorder, Social Anxiety Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Internet-delivered CBT. and On line discussion group in people with Hypochondriasis, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 4 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 6 May 2015. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Health Anxiety Inventory (time frame: 3 days before treatment start). The study lists 4 primary outcomes in all. 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 NCT00828152, which also lists 3 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 6 May 2015.