HypochondriasisHA-XNCT01673035
Internet Treatment for Health Anxiety
A study testing CBT, exposure and response prevention and BSM, stress management and applied relaxation in people with Hypochondriasis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Background Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypochondriasis
- What is being tested?
- CBT, exposure and response prevention and BSM, stress management and applied relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Dec 2015
- 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
- A primary diagnosis of severe health anxiety (hypochondriasis) according to DSM-IV
- At least 18 years old
- Able to read and write in Swedish
Who cannot join
- Other primary axis-I disorder
- Ongoing substance abuse or addiction
- current or previous episode of psychosis or bipolar disorder
- higher score than 30 on the Montgomery åsberg depression rating scale-self report
- higher than 3 on the suicide item of the MADRS-S
- non-stable antidepressant medication during last 2 months if on this kind of medication
Show all 9Show fewer
- ongoing concurrent psychological treatment for severe health anxiety
- having received previous high quality CBT during the recent 3 years
- ongoing serious somatic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments
Background
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Read more
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
Participants in both treatments are expected to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Read the detailed description
Background
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
The investigators expect participants in both treatments to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Design:
Randomized controlled trial. Participants are randomized in a 1:1 ratio.
Assessments:
The primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are conducted at baseline, post-treatment, 3- and 12 month follow-up.
- Conditions
- Hypochondriasis
- Being tested
- CBT, exposure and response prevention, BSM, stress management and applied relaxation
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT, exposure and response preventionBehavioural
This intervention entails different exercises aimed exposure to health anxiety stimuli.
BSM, stress management and applied relaxationBehavioural
BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.
| Study group | Role | What they receive |
|---|---|---|
| internet-based CBT | Experimental | Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided Receives: Behavioral: CBT, exposure and response prevention |
| internet-based BSM | Active comparator | behavioral stress management delivered via the internet: 12 weeks, therapist-guided Receives: Behavioral: BSM, stress management and applied relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Anxiety Inventory (HAI)
Change in HAI at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Secondary outcomes (12)
Illness attitude scale (IAS)
Change in IAS at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Whiteley Index (WI)
Change in WI at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up
Montgomery Åsberg depression rating scale-self report (MADRS-S)
Change in MADRS-S at post-treatment and follow-ups compared to baseline.
Measured: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Beck Anxiety Inventory (BAI)
Change in BAI at post-treatment and follow-ups compared to baseline.
Measured: baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up
Anxiety Sensitivity Index (ASI)
Change in ASI at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Insomnia severity index (ISI)
Change in ISI at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up
Sheehan disability scale (SDS)
Change in SDS at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12) 6-month follow-up, 12-month follow-up
Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
Change in TIC-P at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up
Euroqol-5D (EQ-5D)
Change in EQ-5D)I at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Obsessive compulsive inventory revised (OCI-R)
Only for assessing the sample on this symptom domain at pre-treatment.
Measured: baseline
Yale-brown obsessive compulsive scale (YBOCS)
only for assessing the sample on this domain at pre-treatment
Measured: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52
AUDIT (alcohol use)
Change in AUDIT at post-treatment and follow-ups compared to baseline.
Measured: baseline, 12 weeks, 6 month follow-up, 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 posted27 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2015
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
- Investigators
- Erik Hedman, phd, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673035
- Sponsor's protocol ID
- HA-X
- Acronym
- HA-X
- Status last verified
- Mar 2016
- First submitted
- 22 Aug 2012
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hedman E, Andersson E, Ljotsson B, Axelsson E, Lekander M. Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety. BMJ Open. 2016 Apr 25;6(4):e009327. doi: 10.1136/bmjopen-2015-009327.
PubMed 27113231Hedman E, Axelsson E, Gorling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljotsson B. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2014 Oct;205(4):307-14. doi: 10.1192/bjp.bp.113.140913. Epub 2014 Aug 7.
PubMed 25104835
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments
- ClinicalTrials.gov ID
- NCT01673035
- Acronym / sponsor ID
- HA-X / HA-X
- Conditions
- Hypochondriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Aug 2012 (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.
Background
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
Participants in both treatments are expected to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Detailed description
Background
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
The investigators expect participants in both treatments to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Design:
Randomized controlled trial. Participants are randomized in a 1:1 ratio.
Assessments:
The primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are conducted at baseline, post-treatment, 3- and 12 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internet-based CBT | Experimental | Behavioral: CBT, exposure and response preventionCognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided |
| internet-based BSM | Active comparator | Behavioral: BSM, stress management and applied relaxationbehavioral stress management delivered via the internet: 12 weeks, therapist-guided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A primary diagnosis of severe health anxiety (hypochondriasis) according to DSM-IV
- At least 18 years old
- Able to read and write in Swedish
Key exclusion criteria (9 listed)
- Other primary axis-I disorder
- Ongoing substance abuse or addiction
- current or previous episode of psychosis or bipolar disorder
- higher score than 30 on the Montgomery åsberg depression rating scale-self report
- higher than 3 on the suicide item of the MADRS-S
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 |
|---|---|---|
| CBT, exposure and response preventionThis intervention entails different exercises aimed exposure to health anxiety stimuli. | Behavioural | internet-based CBT |
| BSM, stress management and applied relaxationBSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation. | Behavioural | internet-based BSM |
Primary outcome
Health Anxiety Inventory (HAI)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Change in HAI at post-treatment and follow-ups compared to baseline
12 secondary outcomes
Illness attitude scale (IAS)
Time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Whiteley Index (WI)
Time frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up
Montgomery Åsberg depression rating scale-self report (MADRS-S)
Time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Beck Anxiety Inventory (BAI)
Time frame: baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up
Anxiety Sensitivity Index (ASI)
Time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Insomnia severity index (ISI)
Time frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up
Sheehan disability scale (SDS)
Time frame: baseline, post-treatment (12) 6-month follow-up, 12-month follow-up
Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
Time frame: baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up
Euroqol-5D (EQ-5D)
Time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Obsessive compulsive inventory revised (OCI-R)
Time frame: baseline
Yale-brown obsessive compulsive scale (YBOCS)
Time frame: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52
AUDIT (alcohol use)
Time frame: baseline, 12 weeks, 6 month follow-up, 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 3 Mar 2016.
- Derived from this study: PubMed 27113231Hedman E, Andersson E, Ljotsson B, Axelsson E, Lekander M. Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety. BMJ Open. 2016 Apr 25;6(4):e009327. doi: 10.1136/bmjopen-2015-009327.
- Derived from this study: PubMed 25104835Hedman E, Axelsson E, Gorling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljotsson B. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2014 Oct;205(4):307-14. doi: 10.1192/bjp.bp.113.140913. Epub 2014 Aug 7.
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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.
Erik Hedman, phd principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT, exposure and response prevention and BSM, stress management and applied relaxation 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 3 inclusion and 9 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 3 Mar 2016. 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. 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?
Health Anxiety Inventory (HAI) (time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month 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 NCT01673035, 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 3 Mar 2016.