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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are guided by a therapist. Treatment is delivered via the Internet.
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.
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.
Karolinska Institutet
Stockholm, Stockholm County, Sweden
Health Anxiety Inventory (HAI)
Change in HAI at post-treatment and follow-ups compared to baseline
Time frame: baseline, post-treatment (12 weeks), 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
Obsessive Compulsive Inventory Revised (OCI-R)
Only for assessing the sample on this symptom domain
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Only for assessing the sample on this symptom domain
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
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
The Swedish Scales of Personalities
Change in The Swedish Scales of Personalities 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
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