An interventional study of CBT, exposure and response prevention (Face-to-face) and CBT, exposure and response prevention (Internet-based) in Severe Health Anxiety, Somatic Symptom Disorder and Illness Anxiety Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
Among 13 studies in Medically Unexplained Symptoms with a site in Sweden — 1 open to participants now, 1 under way, none of them phase 3. Medically Unexplained Symptoms · Sweden.
Among the 13 studies in Medically Unexplained Symptoms with a site in Sweden, this one is the 2nd largest by enrollment, is the only one that started in 2014, is one of 13 with no phase, and was the 3rd registered.
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's enrollment of 204 is above the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.
Browse Medically Unexplained Symptoms studies →1 of the 13 studies in Medically Unexplained Symptoms with a site in Sweden is open now, in 1 country. Each count lists the studies.
Of the 20 Medically Unexplained Symptoms studies recruiting now, 6 (30%) set no upper age limit and 12 (60%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2014.
Median enrollment 120 across the 13 interventional studies. Of the 11 that completed or were terminated, 1 (9%) have results posted.
None of the 13 has an industry lead sponsor. The 4 most frequent:
Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Karolinska Institutet has 5 studies filed under Medically Unexplained Symptoms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Medically Unexplained Symptoms with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive Behavioural Therapy delivered in a conventional manner
Behavioral: CBT, exposure and response prevention (Face-to-face)
Cognitive Behavioural Therapy delivered via the Internet
Behavioral: CBT, exposure and response prevention (Internet-based)
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.
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.
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.
Time frame: baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up
Illness Attitude Scale (IAS)
Change in IAS at post-treatment and follow-ups compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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)
Change in TIC-P at post-treatment and follow-ups compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Client Satisfaction Questionnaire (CSQ-8)
For assessing satisfaction with treatment
Time frame: Post-treatment (12 weeks)
Sickness Questionnaire (SQ)
Change in SQ at post-treatment and follow-ups compared to baseline
Time frame: 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
Time frame: 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
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
Change in WHODAS at post-treatment and follow-ups compared to baseline
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
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.
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Credibility/Expectancy scale
For assessing treatment credibility and expectancy of improvement
Time frame: Weeks 2 and 8
Working Alliance Inventory (WAI)
For assessing therapeutic alliance
Time frame: Weeks 2 and 8
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2014 to primary completion in Jul 2018, 43 months.
Of 33 non-industry interventional studies with no phase under Medically Unexplained Symptoms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 43 months is above that.
Counting every sponsor, half of 33 studies reached it within 29 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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