Severe Health AnxietyHA-NonInfNCT02314065

Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy

A study testing CBT, exposure and response prevention (Face-to-face) and CBT, exposure and response prevention (Internet-based) in people with Severe Health Anxiety and Somatic Symptom Disorder, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Background Severe health anxiety is a highly distressing, often debilitating, psychological problem. Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD) or Illness Anxiety Disorder… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Health Anxiety, Somatic Symptom Disorder, Illness Anxiety Disorder
What is being tested?: CBT, exposure and response prevention (Face-to-face) and CBT, exposure and response prevention (Internet-based)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 1 siteSweden
Study dates: 10 Dec 2014to 23 Jul 2018
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 (somatic symptom disorder or illness anxiety disorder) according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
Registered citizen of Stockholm county
At least 18 years old

Who cannot join

Other primary axis-I disorder
Substance abuse or addiction during the last 6 months
Current or previous episode of psychosis or bipolar disorder
Severe major depressive disorder
Suicide risk
Personality disorder making the treatment procedure very difficult

Show all 10Show fewer

Non-stable psychiatric pharmacotherapy (dosage changed during the last 2 months) and the drug is likely to affect outcome measures
Ongoing concurrent psychological treatment for severe health anxiety
Having received previous high quality Cognitive Therapy or Cognitive Behavioural Therapy during the recent year
Ongoing serious somatic disorder, precluding CBT

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Gustavsberg primary care clinic
Gustavsberg, Stockholm County, 13440

Other trials in Sweden

About this study

Official title: Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy

Background

Severe health anxiety is a highly distressing, often debilitating, psychological problem. Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD) or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several treatments for severe health anxiety have shown great promise, the most well-established being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other psychotherapies - has typically been delivered face-to-face. That is, the patient physically meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT does not rest on this requirement, but has nevertheless been shown to be efficacious for severe health anxiety (see for example NCT01673035).

Aim of the study

The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is applied to determine if Internet-delivered CBT is at least as efficacious as its well-established predecessor.

Conditions: Severe Health Anxiety, Somatic Symptom Disorder, Illness Anxiety Disorder
Being tested: CBT, exposure and response prevention (Face-to-face), CBT, exposure and response prevention (Internet-based)
Keywords: Severe health anxiety, Somatic symptom disorder, Illness anxiety disorder, Cognitive behavioral therapy, Internet, Exposure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBT, exposure and response prevention (Face-to-face)Behavioural
This intervention entails different exercises aimed at exposure to health anxiety stimuli.
Treatment is delivered in a conventional manner. Participants are physically meeting with a therapist once a week.
CBT, exposure and response prevention (Internet-based)Behavioural
This intervention entails different exercises aimed at exposure to health anxiety stimuli.
Treatment is delivered via the Internet. Participants are guided by a therapist using an email-like communication system.

Study groups in NCT02314065
Study group	Role	What they receive
Conventional CBT	Experimental	Cognitive Behavioural Therapy delivered in a conventional manner Receives: Behavioral: CBT, exposure and response prevention (Face-to-face)
Internet-delivered CBT	Experimental	Cognitive Behavioural Therapy delivered via the Internet Receives: Behavioral: CBT, exposure and response prevention (Internet-based)

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. Analyses will be conducted both within an intention-to-treat (ITT) framework and on a complete case basis. A non-inferiority limit of 0.3 d (effect size) will be used.
Measured: baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up

Secondary outcomes (17)

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 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
Sheehan Disability Scale (SDS)
Change in SDS at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 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 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
Self-rated health 5 (SRH-5)
Change in SRH-5 at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Quality of Life Inventory (QOLI)
Change in QOLI at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Alcohol Use Disorders Identification Test (AUDIT)
Change in AUDIT at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Client Satisfaction Questionnaire (CSQ-8)
For assessing satisfaction with treatment
Measured: Post-treatment (12 weeks)
Sickness Questionnaire (SQ)
Change in SQ at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Perceived Vulnerability for Disease (PVD)
Change in PVD at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Disgust Scale-Rev (DS-R)
Change in DS-R at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version
Change in WHODAS at post-treatment and follow-ups compared to baseline
Measured: baseline, post-treatment (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.

10 Dec 201423 Jul 2018

First posted10 Dec 2014 (estimated)
Study start10 Dec 2014
Primary completion23 Jul 2018
Study completion23 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Severe Health AnxietyStudies 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: None (open label)
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314065
Sponsor's protocol ID: HA-NonInf
Acronym: HA-NonInf
Status last verified: Oct 2020
First submitted: 8 Dec 2014
Last updated: 29 Oct 2020
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 22608115
Hedman 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
Olatunji BO, Kauffman BY, Meltzer S, Davis ML, Smits JA, Powers MB. Cognitive-behavioral therapy for hypochondriasis/health anxiety: a meta-analysis of treatment outcome and moderators. Behav Res Ther. 2014 Jul;58:65-74. doi: 10.1016/j.brat.2014.05.002. Epub 2014 May 24.
PubMed 24954212
Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
Axelsson E, Osterman S, Hedman-Lagerlof E. Joint factor analysis and approximate equipercentile linking of common trait health anxiety measures: a cross-sectional study of the 14-, 18- and 64-item health anxiety inventory, the illness attitude scale, and the 14-item Whiteley Index. BMC Psychiatry. 2023 Sep 6;23(1):658. doi: 10.1186/s12888-023-05151-7.
PubMed 37674135
Axelsson E, Andersson E, Ljotsson B, Bjorkander D, Hedman-Lagerlof M, Hedman-Lagerlof E. Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):915-924. doi: 10.1001/jamapsychiatry.2020.0940.
PubMed 32401286
Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
PubMed 29222080

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy
ClinicalTrials.gov ID: NCT02314065
Acronym / sponsor ID: HA-NonInf / HA-NonInf
Conditions: Severe Health Anxiety, Somatic Symptom Disorder, Illness Anxiety Disorder
Keywords: Severe health anxiety, Somatic symptom disorder, Illness anxiety disorder, Cognitive behavioral therapy, Internet, Exposure
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Study start: 10 Dec 2014 (actual)
Primary completion: 23 Jul 2018 (actual)
Study completion: 23 Jul 2018 (actual)
First posted: 10 Dec 2014 (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

Aim of the study

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Conventional CBT	Experimental	Behavioral: CBT, exposure and response prevention (Face-to-face)Cognitive Behavioural Therapy delivered in a conventional manner
Internet-delivered CBT	Experimental	Behavioral: CBT, exposure and response prevention (Internet-based)Cognitive Behavioural Therapy delivered via the Internet

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 (somatic symptom disorder or illness anxiety disorder) according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
Registered citizen of Stockholm county
At least 18 years old

Key exclusion criteria (10 listed)

Other primary axis-I disorder
Substance abuse or addiction during the last 6 months
Current or previous episode of psychosis or bipolar disorder
Severe major depressive disorder
Suicide risk

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 prevention (Face-to-face)This intervention entails different exercises aimed at exposure to health anxiety stimuli. Treatment is delivered in a conventional manner. Participants are physically meeting with a therapist once a week.	Behavioural	Conventional CBT
CBT, exposure and response prevention (Internet-based)This intervention entails different exercises aimed at exposure to health anxiety stimuli. Treatment is delivered via the Internet. Participants are guided by a therapist using an email-like communication system.	Behavioural	Internet-delivered CBT

Primary outcome

Health Anxiety Inventory (HAI)
Time frame: baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up
Change in HAI at post-treatment and follow-ups compared to baseline. Analyses will be conducted both within an intention-to-treat (ITT) framework and on a complete case basis. A non-inferiority limit of 0.3 d (effect size) will be used.

17 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 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
Sheehan Disability Scale (SDS)
Time frame: baseline, post-treatment (12 weeks), 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
Insomnia Severity Index (ISI)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Self-rated health 5 (SRH-5)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Quality of Life Inventory (QOLI)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-treatment (12 weeks)
Sickness Questionnaire (SQ)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Perceived Vulnerability for Disease (PVD)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Disgust Scale-Rev (DS-R)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version
Time frame: baseline, post-treatment (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 29 Oct 2020.
Background: 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.
Background: 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.
Background: PubMed 24954212Olatunji BO, Kauffman BY, Meltzer S, Davis ML, Smits JA, Powers MB. Cognitive-behavioral therapy for hypochondriasis/health anxiety: a meta-analysis of treatment outcome and moderators. Behav Res Ther. 2014 Jul;58:65-74. doi: 10.1016/j.brat.2014.05.002. Epub 2014 May 24.
BackgroundFurer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
Derived from this study: PubMed 37674135Axelsson E, Osterman S, Hedman-Lagerlof E. Joint factor analysis and approximate equipercentile linking of common trait health anxiety measures: a cross-sectional study of the 14-, 18- and 64-item health anxiety inventory, the illness attitude scale, and the 14-item Whiteley Index. BMC Psychiatry. 2023 Sep 6;23(1):658. doi: 10.1186/s12888-023-05151-7.
Derived from this study: PubMed 32401286Axelsson E, Andersson E, Ljotsson B, Bjorkander D, Hedman-Lagerlof M, Hedman-Lagerlof E. Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):915-924. doi: 10.1001/jamapsychiatry.2020.0940.
Derived from this study: PubMed 29222080Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
On Somatic Symptom DisorderLink provided by the sponsor.

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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, Ph.D. 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?

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 10 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 29 Oct 2020. 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), weekly during treatment, 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 NCT02314065, which also lists 7 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 29 Oct 2020.