Clinical trial NCT01966705: Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help
Official title: Self-help Based Cognitive Behavior Therapy for Health Anxiety Delivered Via the Internet or in Book Form - the Effect of Administration Strategy and Therapist Contact: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Health Anxiety
Somatic Symptom Disorder
Illness Anxiety Disorder
Keywords: severe health anxiety
somatic symptom disorder
illness anxiety disorder
cognitive behavior therapy
bibliotherapy
internet
exposure
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health Anxiety Inventory (HAI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Secondary outcomes:
measure: Illness Attitude Scale (IAS)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Whiteley Index (WI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Anxiety Sensitivity Index (ASI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Sheehan Disability Scale (SDS)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Euroqol-5D (EQ-5D)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Obsessive Compulsive Inventory Revised (OCI-R)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Self-rated health 5 (SRH-5)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: The Swedish Scales of Personalities
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Quality of Life Inventory (QOLI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Other outcomes:
measure: Psychological mediators
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: The treatment credibility scale
timeFrame: Weeks 2 and 8
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik Hedman, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jones FA. The role of bibliotherapy in health anxiety: an experimental study. Br J Community Nurs. 2002 Oct;7(10):498-504. doi: 10.12968/bjcn.2002.7.10.10662.
citation: Buwalda FM, Bouman TK. Cognitive-behavioural bibliotherapy for hypochondriasis: a pilot study. Behav Cogn Psychother. 2009 May;37(3):335-40. doi: 10.1017/S1352465809005293. Epub 2009 May 6.
citation: Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002 Jul;32(5):843-53. doi: 10.1017/s0033291702005822.
citation: Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
citation: Hedman-Lagerlof E, Axelsson E, Andersson E, Ljotsson B, Andreasson A, Lekander M. The impact of exposure-based cognitive behavior therapy for severe health anxiety on self-rated health: Results from a randomized trial. J Psychosom Res. 2017 Dec;103:9-14. doi: 10.1016/j.jpsychores.2017.09.013. Epub 2017 Sep 28.
citation: Hedman E, Axelsson E, Andersson E, Lekander M, Ljotsson B. Exposure-based cognitive-behavioural therapy via the internet and as bibliotherapy for somatic symptom disorder and illness anxiety disorder: randomised controlled trial. Br J Psychiatry. 2016 Nov;209(5):407-413. doi: 10.1192/bjp.bp.116.181396. Epub 2016 Aug 4.