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Severe Health AnxietyNCT01966705

Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help

A study testing Cognitive Behavior Therapy, exposure and response prevention (Internet, guided), Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided) and Cognitive Behavior Therapy, exposure and response prevention (Book, unguided) 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, Somatic symptom disorder or Illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with considerable personal distress, functional disability and societal costs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive Behavior Therapy, exposure and response prevention (Internet, guided), Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided) and Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteSweden
Study dates
Oct 2013to Nov 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 (somatic symptom disorder or illness anxiety disorder) according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
  • 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
  • Severe major depressive disorder
  • Higher than 5 on the suicidality scale of the Mini International diagnostic Interview
  • Non-stable antidepressant medication (changed during the last 2 months) or not agreeing to keep dosage constant throughout the study
Show all 9Show fewer
  • Ongoing concurrent psychological treatment for severe health anxiety
  • Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy during the recent year
  • Ongoing serious somatic disorder

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Stockholm, Stockholm County, 17177

Other trials in Sweden

About this study

Official title: Self-help Based Cognitive Behavior Therapy for Health Anxiety Delivered Via the Internet or in Book Form - the Effect of Administration Strategy and Therapist Contact: a Randomized Controlled Trial

Background

Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with considerable personal distress, functional disability and societal costs. Several studies have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety, both on anxiety itself and on secondary symptom measures (for example of depression). One published randomized controlled trial (RCT) has examined the feasibility of delivering CBT for severe health anxiety via the Internet as a form of guided self help. Participants had contact with a therapist via an e-mail-like system throughout the treatment. This approach yielded results superior to a waiting-list condition, thus potentially greatly increasing the availability of psychological treatment. However, more studies on the effects of Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For example, the significance of therapist support in relation to treatment outcomes remains to be determined. CBT-based self-help literature, so called bibliotherapy, has shown great promise in the treatment of several anxiety disorders, including panic disorder and social anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or minimal therapist contact could be suitable for treating health anxiety.

Read more

Aim of the study

The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33), Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants with severe health anxiety.

Participants in all treatment programs are expected to be significantly improved on measures of health anxiety, compared to participants allocated to the waiting-list condition.

Being tested
Cognitive Behavior Therapy, exposure and response prevention (Internet, guided), Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided), Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)
Keywords
severe health anxiety, somatic symptom disorder, illness anxiety disorder, cognitive behavior therapy, bibliotherapy, internet, exposure

What participants receive

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

  • Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)Behavioural

    This intervention entails different exercises aimed at exposure to health anxiety stimuli.

    Participants are guided by a therapist. Treatment is delivered via the Internet.

  • Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)Behavioural

    This intervention entails different exercises aimed at exposure to health anxiety stimuli.

    Participants are not guided by a therapist. Treatment is delivered via the Internet.

  • Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)Behavioural

    This intervention entails different exercises aimed at exposure to health anxiety stimuli.

    Participants are not guided by a therapist. Treatment is delivered in book form.

Study groups in NCT01966705
Study groupRoleWhat they receive
Therapist-guided Internet-based Cognitive Behavior TherapyExperimentalCognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help
Receives: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)
Unguided Internet-based Cognitive Behavior TherapyExperimentalCognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only
Receives: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)
Cognitive Behavior Therapy-based bibliotherapyExperimentalCognitive Behavior Therapy delivered in book form: 12 weeks, self-help only
Receives: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)
Waiting-list conditionNo interventionNo intervention: 12 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (15)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Obsessive Compulsive Inventory Revised (OCI-R)

    Only for assessing the sample on this symptom domain

    Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

  10. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Only for assessing the sample on this symptom domain

    Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

  11. 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

  12. 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

  13. 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

  14. The Swedish Scales of Personalities

    Change in The Swedish Scales of Personalities at post-treatment and follow-ups compared to baseline

    Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

  15. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01966705
Sponsor's protocol ID
InterBib
Status last verified
Nov 2015
First submitted
17 Oct 2013
Last updated
5 Nov 2015
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

  • Jones FA. The role of bibliotherapy in health anxiety: an experimental study. Br J Community Nurs. 2002 Oct;7(10):498-504. doi: 10.12968/bjcn.2002.7.10.10662.

    PubMed 12399701

  • Buwalda FM, Bouman TK. Cognitive-behavioural bibliotherapy for hypochondriasis: a pilot study. Behav Cogn Psychother. 2009 May;37(3):335-40. doi: 10.1017/S1352465809005293. Epub 2009 May 6.

    PubMed 19416560

  • Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002 Jul;32(5):843-53. doi: 10.1017/s0033291702005822.

    PubMed 12171378

  • 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

  • Hedman-Lagerlof E, Axelsson E, Andersson E, Ljotsson B, Andreasson A, Lekander M. The impact of exposure-based cognitive behavior therapy for severe health anxiety on self-rated health: Results from a randomized trial. J Psychosom Res. 2017 Dec;103:9-14. doi: 10.1016/j.jpsychores.2017.09.013. Epub 2017 Sep 28.

    PubMed 29167052

  • Hedman E, Axelsson E, Andersson E, Lekander M, Ljotsson B. Exposure-based cognitive-behavioural therapy via the internet and as bibliotherapy for somatic symptom disorder and illness anxiety disorder: randomised controlled trial. Br J Psychiatry. 2016 Nov;209(5):407-413. doi: 10.1192/bjp.bp.116.181396. Epub 2016 Aug 4.

    PubMed 27491531

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavior Therapy, exposure and response prevention (Internet, guided), Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided) and Cognitive Behavior Therapy, exposure and response prevention (Book, unguided) in people with Severe Health Anxiety and Somatic Symptom Disorder, 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 5 Nov 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. 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 NCT01966705, which also lists 8 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 5 Nov 2015.

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