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

Summary

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.

Conditions

• Illness Anxiety Disorder
• Somatic Symptom Disorder
• Health Anxiety

Interventions

BEHAVIORAL

Brief Cognitive-Behavioral Therapy for Health Anxiety

4-session in-person 45-minute psychotherapy sessions focused on building motivation for change, psychoeducation, cognitive restructuring, and situational and interoceptive exposure to health-related fear stimuli.

BEHAVIORAL

Referral to mental health provider

Provider makes a referral to a mental health provider in the outpatient psychiatry clinic or a community provider of the participant's choice.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Dartmouth-Hitchcock Medical Center

  lead OTHER

Principal Investigators

• Robert E Brady, PhD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-26

Primary Completion

2025-07-01

Completion

2025-10-30

Countries

• United States

Study Locations