Hybrid Trial of Brief Cognitive-Behavioral Therapy for Health Anxiety in Primary Care

Completed · Not applicable

Conditions studied: Illness Anxiety Disorder, Somatic Symptom Disorder, Health Anxiety

In brief

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.

Key facts

Study ID

NCT03789084

Run by

Dartmouth-Hitchcock Medical Center

People needed

68

Starts

2019-03-26

Expected to finish

2025-10-30

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of 18 years to 85
• Have a primary care provider at Dartmouth-Hitchcock Medical Center-General Internal Medicine, Dartmouth-Hitchcock Heater Road Clinic, or Dartmouth-Hitchcock Manchester
• Primary care visit frequency of two standard deviations above the mean for patients in the individual's age by gender cohort
• Elevated self-reported health anxiety (≥2 on Whiteley Index-7)
• Diagnosis of illness anxiety disorder or somatic symptom disorder determined by Health Anxiety Interview

You may not qualify if…

• Non-English speaking
• Chronic medical illness necessitating an increased visit frequency confirmed through consultation with the patient's primary care provider
• Active suicidal ideation
• Unmanaged psychosis or unmanaged bipolar disorder

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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