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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT02314065
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.4
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Health Anxiety; Somatic Symptom Disorder; Illness Anxiety Disorder	Behavioral: CBT, exposure and response prevention (Face-to-face); Behavioral: CBT, exposure and response prevention (Internet-based)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy
• Actual Study Start Date: Dec 10, 2014
• Actual Primary Completion Date: Jul 23, 2018
• Actual Study Completion Date: Jul 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional CBT Cognitive Behavioural Therapy delivered in a conventional manner	Behavioral: CBT, exposure and response prevention (Face-to-face); This intervention entails different exercises aimed at exposure to health anxiety stimuli. Treatment is delivered in a conventional manner. Participants are physically meeting with a therapist once a week.
Experimental: Internet-delivered CBT Cognitive Behavioural Therapy delivered via the Internet	Behavioral: CBT, exposure and response prevention (Internet-based); This intervention entails different exercises aimed at exposure to health anxiety stimuli. Treatment is delivered via the Internet. Participants are guided by a therapist using an email-like communication system.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Client Satisfaction Questionnaire (CSQ-8) [Post-treatment (12 weeks)]

    For assessing satisfaction with treatment

14. 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

15. 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

16. 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

17. 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

Other Outcome Measures

1. 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, the Insomnia Severity Index, Self-Rated Health 5 and Acceptance/Flexibility. Common health anxiety behaviors will also be assessed.

2. Credibility/Expectancy scale [Weeks 2 and 8]

   For assessing treatment credibility and expectancy of improvement

3. Working Alliance Inventory (WAI) [Weeks 2 and 8]

   For assessing therapeutic alliance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

• Registered citizen of Stockholm county

• At least 18 years old

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustavsberg primary care clinic	Gustavsberg	Stockholm	Sweden	13440

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Erik Hedman, Ph.D., Karolinska Institutet

Study Documents (Full-Text)

• Statistical Analysis Plan - Aug 31, 2016

More Information

Additional Information:

• On Somatic Symptom Disorder

Publications

• Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
• Hedman E, Andersson E, Lindefors N, Andersson G, Rück C, Ljótsson 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.
• Hedman E, Axelsson E, Görling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljótsson B. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2014 Oct;205(4):307-14. doi: 10.1192/bjp.bp.113.140913. Epub 2014 Aug 7.
• Olatunji BO, Kauffman BY, Meltzer S, Davis ML, Smits JA, Powers MB. Cognitive-behavioral therapy for hypochondriasis/health anxiety: a meta-analysis of treatment outcome and moderators. Behav Res Ther. 2014 Jul;58:65-74. doi: 10.1016/j.brat.2014.05.002. Epub 2014 May 24.

• Responsible Party: Erik Hedman, PhD, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02314065
• Other Study ID Numbers: HA-NonInf
• First Posted: Dec 10, 2014
• Last Update Posted: Oct 29, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Erik Hedman, PhD, Karolinska Institutet: Severe health anxiety; Somatic symptom disorder; Illness anxiety disorder; Cognitive behavioral therapy; Internet; Exposure
• Additional relevant MeSH terms: Disease; Medically Unexplained Symptoms; Anxiety Disorders

Study Results

No Results Posted as of Oct 29, 2020