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

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ClinicalTrials.gov Identifier: NCT02314065
Recruitment Status : Active, not recruiting
First Posted : December 10, 2014
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Erik Hedman, 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.


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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : December 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.





Primary Outcome Measures :
  1. Health Anxiety Inventory (HAI) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Post-treatment (12 weeks) ]
    For assessing satisfaction with treatment

  14. Sickness Questionnaire (SQ) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Weeks 2 and 8 ]
    For assessing treatment credibility and expectancy of improvement

  3. Working Alliance Inventory (WAI) [ Time Frame: Weeks 2 and 8 ]
    For assessing therapeutic alliance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314065


Locations
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Sweden
Gustavsberg primary care clinic
Gustavsberg, Stockholm, Sweden, 13440
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Erik Hedman, Ph.D. Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Erik Hedman, Karolinska Institutet:
Statistical Analysis Plan  [PDF] August 31, 2016


Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erik Hedman, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02314065     History of Changes
Other Study ID Numbers: HA-NonInf
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Erik Hedman, Karolinska Institutet:
Severe health anxiety
Somatic symptom disorder
Illness anxiety disorder
Cognitive behavioral therapy
Internet
Exposure

Additional relevant MeSH terms:
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Disease
Medically Unexplained Symptoms
Anxiety Disorders
Pathologic Processes
Mental Disorders
Signs and Symptoms