Cognitive-Behavioral Therapy for Health Anxiety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Non-English, Chronic illness, Suicidal, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Brief Cognitive-Behavioral Therapy for Health Anxiety?

Research shows that cognitive-behavioral therapy (CBT) is effective in reducing health anxiety, with significant improvements seen in both individual and group settings. Studies indicate that patients experience large improvements in health anxiety symptoms, which are maintained over time, making CBT a reliable treatment option for health anxiety. ^{1 2 3 4 5}

Is Cognitive-Behavioral Therapy for Health Anxiety safe?

Cognitive-Behavioral Therapy (CBT) for health anxiety is generally considered safe, but there is limited monitoring of adverse events in behavioral health trials. Temporary increases in anxiety may occur, but these are often seen as a normal part of therapy. ^{6 7 8 9 10}

How does Brief Cognitive-Behavioral Therapy for Health Anxiety differ from other treatments for this condition?

Brief Cognitive-Behavioral Therapy for Health Anxiety is unique because it focuses on changing thought patterns and behaviors that contribute to health anxiety, and it can be delivered in a brief format, potentially making it more accessible and cost-effective compared to traditional face-to-face therapy sessions. ^{7 9 11 12 13}

What is the purpose of this trial?

This study is a randomized controlled pilot trial using a hybrid type 1 effectiveness-implementation design to evaluate the feasibility, acceptability, and preliminary effectiveness of a brief cognitive-behavioral intervention delivered by medical assistants in a primary care setting. The trial compares clinical outcomes of participants assigned to the intervention condition to those of participants assigned to a usual care condition. The clinical outcome is change on a self-report measure of health anxiety. Assessments occur at baseline, four weeks, and 12 weeks post-treatment. The study will also measure engagement with the intervention and assess feasibility and acceptability of the intervention in terms of fidelity of trained study therapists and ratings of the intervention by participants. The usual care condition consists of a referral to a mental health provider. The intervention is comprised of four sessions of individually administered cognitive-behavioral therapy addressing health anxiety. Treatment focuses on building motivation for change, psychoeducation about health anxiety, cognitive restructuring, and situational and interoceptive exposure. The study will recruit from three primary care clinics within the Dartmouth-Hitchcock Health system. The study will also assess facilitators and barriers to implementation using qualitative analyses of interview responses provided by the medical assistants delivering the intervention, primary care providers, and clinic administrators at the study sites.

Research Team

Robert E Brady, PhD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults aged 18-85 with health anxiety or somatic symptom disorder, who see their primary care provider often and have high self-reported health anxiety. They must be patients at specific Dartmouth-Hitchcock clinics and speak English. Those with chronic illnesses requiring frequent visits, unmanaged psychosis or bipolar disorder, or active suicidal thoughts cannot join.

Inclusion Criteria

I visit my primary care doctor much more often than most people my age and gender.

Have a primary care provider at Dartmouth-Hitchcock Medical Center-General Internal Medicine, Dartmouth-Hitchcock Heater Road Clinic, or Dartmouth-Hitchcock Manchester

You frequently worry about your health, scoring 2 or more on a health anxiety test.

Exclusion Criteria

Chronic medical illness necessitating an increased visit frequency confirmed through consultation with the patient's primary care provider

You have untreated or uncontrolled mental health conditions like psychosis or bipolar disorder.

I am currently having thoughts about harming myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week to 1 month

Treatment

Participants receive four sessions of individually administered cognitive-behavioral therapy addressing health anxiety

4 weeks

4 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Assessments at 4 weeks and 12 weeks post-treatment

Treatment Details

Interventions

• Brief Cognitive-Behavioral Therapy for Health Anxiety
• Referral to mental health provider

Trial Overview The study tests a short cognitive-behavioral therapy (CBT) for health anxiety in primary care versus usual care which involves referral to a mental health provider. The CBT includes four sessions focusing on motivation, education about health anxiety, thought restructuring, and exposure exercises. Outcomes are measured over 12 weeks post-treatment.

Participant Groups

Group I: Referral to mental health provider Experimental Treatment 1 Intervention

Provider makes referral to a mental health provider

Group II: Cognitive-Behavioral Therapy Experimental Treatment 1 Intervention

Brief Cognitive-Behavioral Therapy for Health Anxiety

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a systematic review of 19 randomized controlled trials involving 2188 participants, 10% of those undergoing cognitive behavior therapy (CBT) for health anxiety reported adverse events, and 17% dropped out of the treatment, indicating that while CBT is effective, it can have unwanted outcomes.

In a secondary study of 336 participants, 17% reported adverse events, and 0-10% experienced overall symptom deterioration, suggesting that while CBT is generally effective, there is variability in individual experiences and a need for strategies to minimize dropouts and adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials. Axelsson, E., Hedman-Lagerlöf, E.[2023]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

Extending the use of routine outcome monitoring: Predicting long-term outcomes in cognitive behavioral therapy for severe health anxiety. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Predictors of outcome in Internet-based cognitive behavior therapy for severe health anxiety. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioral therapy versus psychoeducation control for illness anxiety disorder and somatic symptom disorder: A randomized controlled trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A randomized trial of two forms of cognitive behaviour therapy for an older adult population with subclinical health anxiety. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral group therapy for patients with hypochondriasis (health anxiety). [2019]

6. England pubmed.ncbi.nlm.nih.gov

Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral responses to illness information: the role of health anxiety. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot trial of a therapist-supported internet-delivered cognitive behavioural therapy program for health anxiety. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for severe health anxiety (hypochondriasis): an interpretative phenomenological analysis of patients' experiences. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Clinical and cost-effectiveness of cognitive behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Therapist differences in a randomised trial of the outcome of cognitive behaviour therapy for health anxiety in medical patients. [2021]