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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional CBT | Experimental | Cognitive Behavioural Therapy delivered in a conventional manner |
|
| Internet-delivered CBT | Experimental | Cognitive Behavioural Therapy delivered via the Internet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT, exposure and response prevention (Face-to-face) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Illness Attitude Scale (IAS) | Change in IAS at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up |
| Whiteley Index (WI) |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological mediators | Assessment of whether these mediators will precede change in outcome during the treatment. Mediators will be assessed using sub scales of the Health Anxiety Inventory, the Insomnia Severity Index, Self-Rated Health 5 and Acceptance/Flexibility. Common health anxiety behaviors will also be assessed. | week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Hedman, Ph.D. | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustavsberg primary care clinic | Gustavsberg | Stockholm County | 13440 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22608115 | Background | 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. | |
| 25104835 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2016 | Feb 20, 2018 |
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| CBT, exposure and response prevention (Internet-based) | Behavioral | 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. |
|
Change in WI at post-treatment and follow-ups compared to baseline
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up |
| Client Satisfaction Questionnaire (CSQ-8) | For assessing satisfaction with treatment | Post-treatment (12 weeks) |
| Sickness Questionnaire (SQ) | Change in SQ at post-treatment and follow-ups compared to baseline | 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 | 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 | 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 | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up |
| Credibility/Expectancy scale | For assessing treatment credibility and expectancy of improvement | Weeks 2 and 8 |
| Working Alliance Inventory (WAI) | For assessing therapeutic alliance | Weeks 2 and 8 |
| 24954212 | Background | 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. |
| Background | Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005. |
| 37674135 | Derived | 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. |
| 32401286 | Derived | 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. |
| 29222080 | Derived | 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. |
| SAP_000.pdf |