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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a short cognitive-behavioral therapy (CBT) designed to help people who often worry about their health. The goal is to determine if this therapy can reduce health anxiety, defined as the constant fear of being sick. Participants will either receive the CBT or a referral to a mental health provider. The trial seeks individuals who frequently visit their primary care doctor and have high levels of health anxiety. As an unphased trial, it offers participants the chance to contribute to understanding new ways to manage health anxiety.

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 prior data suggests that this cognitive-behavioral therapy is safe for health anxiety?

Research has shown that cognitive-behavioral therapy (CBT) is generally safe for treating health anxiety. Studies indicate that about 66% of people respond well to CBT, with around 48% experiencing a significant reduction in their anxiety symptoms, known as remission. However, some reports suggest that up to 10% of people might feel worse after CBT, and 10-19% might stop treatment early. These findings suggest that while most people handle CBT well, a small group may have negative experiences. Overall, CBT is considered a top treatment for anxiety, making it a reliable choice for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for health anxiety involve medication or traditional long-term therapy. However, Brief Cognitive-Behavioral Therapy (CBT) for health anxiety is unique because it offers a focused, short-term approach that can deliver results more quickly. Researchers are excited about this treatment because it targets the specific thought patterns and behaviors associated with health anxiety in a concise manner, potentially making it more accessible and appealing for those who prefer not to commit to long-term therapy. This could provide an effective alternative for individuals seeking faster relief from health anxiety symptoms without relying on medication.

What evidence suggests that this trial's treatments could be effective for health anxiety?

Research has shown that cognitive-behavioral therapy (CBT), which participants in this trial may receive, effectively treats health anxiety. Studies indicate that even short CBT sessions can significantly improve mental health, with 66% of people responding well to the treatment and 48% experiencing full recovery. This therapy helps by changing thought and behavior patterns to reduce anxiety. Overall, CBT is considered a helpful approach for those dealing with health anxiety. Another group in this trial will receive a referral to a mental health provider, another treatment option under evaluation. ^{1 5 6 7 8}

Who Is on the Research Team?

Robert E Brady, PhD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40532304/

Effectiveness of brief group cognitive behavioural therapy ... Conclusions: These results overall confirmed that even very brief group CBT therapies have significant and relatively stable efficacy on mental health benefits, ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/14737167.2019.1703182

Full article: Cognitive behavior therapy for health anxiety The pooled CBT response rate was 66%, and the remission rate 48%. ICBT had effects comparable to face-to-face CBT. CBT for health anxiety is probably cost- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584580/

The Efficacy of Cognitive Behavioral Therapy: A Review ... For the treatment of premenstrual syndrome, Busse and colleagues (2009) found that CBT significantly reduced depressive and anxiety symptoms associated with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03789084

Hybrid Trial of Brief Cognitive-Behavioral Therapy for ... The HAI can be administered in approximately 30 minutes. Reliability data are not available for the HAI, but it has been used successfully in health anxiety ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125002380

Effectiveness of brief group cognitive behavioural therapy ... Brief group CBTs can effectively treat depression and anxiety symptoms. Brief group CBTs effectively enhance self-esteem and global mental-health.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8475916/

Cognitive-Behavioral Treatments for Anxiety and Stress ... CBT is an effective, gold-standard treatment for anxiety and stress-related disorders. CBT uses specific techniques to target unhelpful thoughts, feelings, and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00828152

Internet-delivered Cognitive Behavioral Therapy (CBT) for ... The aim of this study is to investigate whether CBT remains effective when administered via a self-help programme on the Internet. Official Title. Internet- ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37614181/

Unwanted outcomes in cognitive behavior therapy for ... About 0–10% rated their health anxiety as having become worse after CBT, and 10–19% dropped out prematurely. In CBT delivered via the Internet, ...