Illness Anxiety Disorder, Severe Health Anxiety, Somatic Symptom Disorder
Conditions
Keywords
Severe health anxiety, Somatic symptom disorder, Illness anxiety disorder, Cognitive behavioral therapy, Internet, Exposure
Brief 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 (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.
Interventions
BEHAVIORALCBT, 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.
BEHAVIORALCBT, 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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Anxiety Inventory (HAI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Euroqol-5D (EQ-5D) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in EQ-5D at post-treatment and follow-ups compared to baseline |
| Perceived Vulnerability for Disease (PVD) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in PVD at post-treatment and follow-ups compared to baseline |
| Disgust Scale-Rev (DS-R) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in DS-R at post-treatment and follow-ups compared to baseline |
| WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in WHODAS at post-treatment and follow-ups compared to baseline |
| Illness Attitude Scale (IAS) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in IAS at post-treatment and follow-ups compared to baseline |
| Whiteley Index (WI) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in WI at post-treatment and follow-ups compared to baseline |
| Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in MADRS-S at post-treatment and follow-ups compared to baseline |
| Beck Anxiety Inventory (BAI) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in BAI at post-treatment and follow-ups compared to baseline |
| Anxiety Sensitivity Index (ASI) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in ASI at post-treatment and follow-ups compared to baseline |
| Sheehan Disability Scale (SDS) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in SDS at post-treatment and follow-ups compared to baseline |
| Trimbos and institute of medical technology assessment cost questionnaire (TIC-P) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in TIC-P at post-treatment and follow-ups compared to baseline |
| Insomnia Severity Index (ISI) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in ISI at post-treatment and follow-ups compared to baseline |
| Self-rated health 5 (SRH-5) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in SRH-5 at post-treatment and follow-ups compared to baseline |
| Quality of Life Inventory (QOLI) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in QOLI at post-treatment and follow-ups compared to baseline |
| Alcohol Use Disorders Identification Test (AUDIT) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in AUDIT at post-treatment and follow-ups compared to baseline |
| Client Satisfaction Questionnaire (CSQ-8) | Post-treatment (12 weeks) | For assessing satisfaction with treatment |
| Sickness Questionnaire (SQ) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in SQ at post-treatment and follow-ups compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Working Alliance Inventory (WAI) | Weeks 2 and 8 | For assessing therapeutic alliance |
| Credibility/Expectancy scale | Weeks 2 and 8 | For assessing treatment credibility and expectancy of improvement |
| Psychological mediators | week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 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. |
Countries
Sweden
Outcome results
None listed