Illness Anxiety Disorder, Severe Health Anxiety, Somatic Symptom Disorder
Conditions
Keywords
severe health anxiety, somatic symptom disorder, illness anxiety disorder, cognitive behavior therapy, bibliotherapy, internet, exposure
Brief 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. 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. 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.
Interventions
BEHAVIORALCognitive Behavior Therapy, exposure and response prevention (Internet, guided)
This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are guided by a therapist. Treatment is delivered via the Internet.
BEHAVIORALCognitive Behavior Therapy, exposure and response prevention (Internet, unguided)
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.
BEHAVIORALCognitive Behavior Therapy, exposure and response prevention (Book, unguided)
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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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) * At least 18 years old * Able to read and write in Swedish
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Anxiety Inventory (HAI) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in HAI at post-treatment and follow-ups compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| The Swedish Scales of Personalities | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Change in The Swedish Scales of Personalities 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 |
| Obsessive Compulsive Inventory Revised (OCI-R) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Only for assessing the sample on this symptom domain |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | Only for assessing the sample on this symptom domain |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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, and the Insomnia Severity Index, Perceived Competence Scale, Working Alliance Inventory, Five Facet Mindfulness Questionnaire, Acceptance and Flexibility, and Somatosensory Amplification Scale |
| The treatment credibility scale | Weeks 2 and 8 | For assessing treatment credibility and expectancy of improvement |
Countries
Sweden
Outcome results
None listed