search
Back to results

Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help

Primary Purpose

Severe Health Anxiety, Somatic Symptom Disorder, Illness Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)
Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)
Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Health Anxiety focused on measuring severe health anxiety, somatic symptom disorder, illness anxiety disorder, cognitive behavior therapy, bibliotherapy, internet, exposure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Therapist-guided Internet-based Cognitive Behavior Therapy

Unguided Internet-based Cognitive Behavior Therapy

Cognitive Behavior Therapy-based bibliotherapy

Waiting-list condition

Arm Description

Cognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help

Cognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only

Cognitive Behavior Therapy delivered in book form: 12 weeks, self-help only

No intervention: 12 weeks

Outcomes

Primary Outcome Measures

Health Anxiety Inventory (HAI)
Change in HAI at post-treatment and follow-ups compared to baseline

Secondary Outcome Measures

Illness Attitude Scale (IAS)
Change in IAS at post-treatment and follow-ups compared to baseline
Whiteley Index (WI)
Change in WI at post-treatment and follow-ups compared to baseline
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)
Change in MADRS-S at post-treatment and follow-ups compared to baseline
Beck Anxiety Inventory (BAI)
Change in BAI at post-treatment and follow-ups compared to baseline
Anxiety Sensitivity Index (ASI)
Change in ASI at post-treatment and follow-ups compared to baseline
Sheehan Disability Scale (SDS)
Change in SDS at post-treatment and follow-ups compared to baseline
Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
Change in TIC-P at post-treatment and follow-ups compared to baseline
Euroqol-5D (EQ-5D)
Change in EQ-5D at post-treatment and follow-ups compared to baseline
Obsessive Compulsive Inventory Revised (OCI-R)
Only for assessing the sample on this symptom domain
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Only for assessing the sample on this symptom domain
Alcohol Use Disorders Identification Test (AUDIT)
Change in AUDIT at post-treatment and follow-ups compared to baseline
Insomnia Severity Index (ISI)
Change in ISI at post-treatment and follow-ups compared to baseline
Self-rated health 5 (SRH-5)
Change in SRH-5 at post-treatment and follow-ups compared to baseline
The Swedish Scales of Personalities
Change in The Swedish Scales of Personalities at post-treatment and follow-ups compared to baseline
Quality of Life Inventory (QOLI)
Change in QOLI at post-treatment and follow-ups compared to baseline

Full Information

First Posted
October 17, 2013
Last Updated
November 4, 2015
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT01966705
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapist-guided Internet-based Cognitive Behavior Therapy
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help
Arm Title
Unguided Internet-based Cognitive Behavior Therapy
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only
Arm Title
Cognitive Behavior Therapy-based bibliotherapy
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy delivered in book form: 12 weeks, self-help only
Arm Title
Waiting-list condition
Arm Type
No Intervention
Arm Description
No intervention: 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)
Intervention Description
This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are guided by a therapist. Treatment is delivered via the Internet.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Anxiety Inventory (HAI)
Description
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
Secondary Outcome Measure Information:
Title
Illness Attitude Scale (IAS)
Description
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
Title
Whiteley Index (WI)
Description
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
Title
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)
Description
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
Title
Beck Anxiety Inventory (BAI)
Description
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
Title
Anxiety Sensitivity Index (ASI)
Description
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
Title
Sheehan Disability Scale (SDS)
Description
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
Title
Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
Description
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
Title
Euroqol-5D (EQ-5D)
Description
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
Title
Obsessive Compulsive Inventory Revised (OCI-R)
Description
Only for assessing the sample on this symptom domain
Time Frame
baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
Only for assessing the sample on this symptom domain
Time Frame
baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
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
Title
Insomnia Severity Index (ISI)
Description
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
Title
Self-rated health 5 (SRH-5)
Description
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
Title
The Swedish Scales of Personalities
Description
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
Title
Quality of Life Inventory (QOLI)
Description
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
Other Pre-specified Outcome Measures:
Title
Psychological mediators
Description
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
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
The treatment credibility scale
Description
For assessing treatment credibility and expectancy of improvement
Time Frame
Weeks 2 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Hedman, phd
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
22608115
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.
Results Reference
background
PubMed Identifier
12399701
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.
Results Reference
background
PubMed Identifier
19416560
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.
Results Reference
background
PubMed Identifier
12171378
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.
Results Reference
background
Citation
Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
Results Reference
background
PubMed Identifier
29167052
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.
Results Reference
derived
PubMed Identifier
27491531
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.
Results Reference
derived
Links:
URL
http://www.psych.org/File%20Library/Practice/DSM/DSM-5/DSM-5-Somatic-Symptom-Disorder.pdf
Description
On Somatic Symptom Disorder

Learn more about this trial

Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help

We'll reach out to this number within 24 hrs