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

NCT03789084 | Completed

• 2 other identifiers: D190446K23MH116367-02
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in health anxiety, measured by the Short Health Anxiety Inventory

  The Short Health Anxiety Inventory is an 18-item measure of health anxiety in which respondents identify which statement applies best to them among four choices per item scored from 0 to 3 (e.g., "I do not worry about my health" = 0, "I spend most of my time worrying about my health" = 3). The scale range is 0 to 54. Higher scores correspond to increased health anxiety.

  Baseline, Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup)

Secondary Outcomes (2)

• Acceptability of the intervention, measured by the Treatment Evaluation Inventory-Short Form

  Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup)

• Change in readiness for intervention, measured by the University of Rhode Island Change Assessment-Psychotherapy Version

  Baseline, Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup)

Other Outcomes (5)

• Fidelity to the intervention following training, measured by the Cognitive Therapy Scale-Revised

  1 to 15 months before Baseline

• Psychiatric diagnostic comorbidity, assessed by the Mini-International Neuropsychiatric Interview

  Baseline

• Medical diagnostic comorbidity, assessed by the Charlton Age-Comorbidity Index

  Baseline

Study Arms (2)

Cognitive-Behavioral Therapy

EXPERIMENTAL

Brief Cognitive-Behavioral Therapy for Health Anxiety

Behavioral: Brief Cognitive-Behavioral Therapy for Health Anxiety

Referral to mental health provider

OTHER

Provider makes referral to a mental health provider

Behavioral: Referral to mental health provider

Interventions

Brief Cognitive-Behavioral Therapy for Health Anxiety BEHAVIORAL

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.

Cognitive-Behavioral Therapy

Referral to mental health provider BEHAVIORAL

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

Referral to mental health provider

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• Brady RE, Hegel MT, Curran GM, Asmundson GJG, Xie H, Bruce ML. Evaluation of a brief psychosocial intervention for health anxiety delivered by medical assistants in primary care: Study protocol for a pilot hybrid trial. Contemp Clin Trials. 2021 Dec;111:106574. doi: 10.1016/j.cct.2021.106574. Epub 2021 Oct 7.

  PMID: 34628077 BACKGROUND

• Brady RE, Braz AN. Challenging Interactions Between Patients With Severe Health Anxiety and the Healthcare System: A Qualitative Investigation. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231214876. doi: 10.1177/21501319231214876.

  PMID: 38041442 BACKGROUND

Study Officials

• Robert E Brady, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: March 26, 2019
• Primary Completion: July 1, 2025
• Study Completion: October 30, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available immediately and indefinitely following primary outcome manuscript publication.
• Access Criteria: Replication trials, meta-analyses; requests should be made directly to Principal investigator at Robert.E.Brady@hitchcock.org.

Locations

US (1)