Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy

Not Applicable

Completed

• Conditions: Somatic Symptom Disorder; Severe Health Anxiety; Illness Anxiety Disorder
• Interventions: Behavioral: CBT, exposure and response prevention (Internet-based); Behavioral: CBT, exposure and response prevention (Face-to-face)

• Registration Number: NCT02314065
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-09
• Study Start: 2014-12-10
• Study First Posted: 2014-12-10
• Primary Completion: 2018-07-23
• Study Completion: 2018-07-23
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-delivered CBT	CBT, exposure and response prevention (Internet-based)	Cognitive Behavioural Therapy delivered via the Internet
Conventional CBT	CBT, exposure and response prevention (Face-to-face)	Cognitive Behavioural Therapy delivered in a conventional manner

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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
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
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
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
Client Satisfaction Questionnaire (CSQ-8)	Post-treatment (12 weeks)	For assessing satisfaction with treatment
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
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

Trial Locations

Locations (1)

Gustavsberg primary care clinic; 🇸🇪 Gustavsberg, Stockholm, Sweden