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

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ClinicalTrials.gov Identifier: NCT03789084
Recruitment Status : Enrolling by invitation
First Posted : December 28, 2018
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robert E. Brady, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Illness Anxiety Disorder Somatic Symptom Disorder Health Anxiety Behavioral: Brief Cognitive-Behavioral Therapy for Health Anxiety Behavioral: Referral to mental health provider Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Hybrid Type 1 Trial Evaluating the Feasibility, Acceptability, Preliminary Effectiveness of Brief Cognitive-behavioral Therapy for Health Anxiety Delivered by Medical Assistants in Primary Care
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive-Behavioral Therapy
Brief Cognitive-Behavioral Therapy for Health Anxiety
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.

Referral to mental health provider
Provider makes referral to a mental health provider
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.




Primary Outcome Measures :
  1. Change from baseline in health anxiety, measured by the Short Health Anxiety Inventory [ Time Frame: Baseline, Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup) ]
    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.


Secondary Outcome Measures :
  1. Acceptability of the intervention, measured by the Treatment Evaluation Inventory-Short Form [ Time Frame: Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup) ]
    The Treatment Evaluation Inventory-Short Form is a 9-item measure of treatment acceptability (e.g., "I like the procedures used in this treatment") rated on a five-point Likert scale from "strongly disagree" to "strongly agree" and modified to focus on interventions administered to adults. The scale range is 9 to 45. Higher scores correspond to greater acceptability of the intervention.

  2. Change in readiness for intervention, measured by the University of Rhode Island Change Assessment-Psychotherapy Version [ Time Frame: Baseline, Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup) ]
    The University of Rhode Island Change Assessment-Psychotherapy Version is a 32-item measure of readiness for change. Items are rated on a five-point Likert scale from "strongly disagree" to "strongly agree" for each item (e.g., "I think I might be ready for some self-improvement."). The scale range is 32 to 160. Higher scores correspond to increased readiness for change.


Other Outcome Measures:
  1. Fidelity to the intervention following training, measured by the Cognitive Therapy Scale-Revised [ Time Frame: 1 to 15 months before Baseline ]
    The Revised-Cognitive Therapy Scale is a 12-item measure of therapist fidelity to cognitive-behavioral therapy (CBT). Items are rated on a seven-point scale of ability to apply CBT principles (0 = "Incompetent" to 6 = "Expert"), by an evaluator with expertise in CBT. A score of ≥36 is the recommended cut-off for CBT fidelity. The scale range is 0 to 72. Higher scores correspond to greater fidelity to the CBT model.

  2. Psychiatric diagnostic comorbidity, assessed by the Mini-International Neuropsychiatric Interview [ Time Frame: Baseline ]
    The Mini-International Neuropsychiatric Interview (MINI) is a widely used brief structured psychiatric diagnostic interview for 17 International Classification of Diseases-10 psychiatric disorders. Each item from the MINI is answered in a dichotomous, yes/no format with additional prompts used by the assessor to clarify ambiguous responses.

  3. Medical diagnostic comorbidity, assessed by the Charlton Age-Comorbidity Index [ Time Frame: Baseline ]
    The Charlson Age-Comorbidity Index is a combined age and comorbidity index in which each decade of life ≥50 years equals a 1-point increase in comorbidity alongside scores assigned to specific disease states. Scores range from 0 to 39, with comorbidities of greater severity assigned higher scores of 1, 2, 3, or 6. Higher scores are associated with greater likelihood of death from the identified comorbid conditions.

  4. Determination of health anxiety diagnoses, assessed by the Health Anxiety Interview [ Time Frame: Baseline ]
    The Health Anxiety Interview (HAI) is a brief clinician-administered semi-structured interview of health anxiety and related disorders. 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 outcome trials research. The HAI will be used to verify the presence of excessive health anxiety identified on the WI-7.

  5. Measurement of health anxiety for screening purposes, assessed by the Whiteley Index-7 [ Time Frame: 1 week to 1 month before Baseline ]
    The Whiteley Index-7 (WI-7) is comprised of seven items assessing health anxiety. Respondents indicate how much an item is representative of them (e.g., "Do you often worry about the possibility that you have a serious illness'') using dichotomous scaling. The WI-7 has good sensitivity and specificity for identification of excessive health anxiety. A score of ≥2 is indicative of excessive health anxiety. The scale range is 0 to 7. Higher scores correspond to greater health anxiety.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789084


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Robert E Brady, PhD Dartmouth-Hitchcock Medical Center

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Responsible Party: Robert E. Brady, Assistant Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03789084     History of Changes
Other Study ID Numbers: D19044
6K23MH116367-02 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results will be posted to ClinicalTrials.gov in a timely manner with the goal of posting the results as soon as possible following completion of primary analyses and not more than one year after completion of the final participant's participation in the trial. This corresponds to the third year of the career development award period for the hybrid trial covered in this study record. Deidentified individual participant data (IPD) will be available upon request from researchers with a sound research and analytic plan, including replication or inclusion in meta-analysis. IPD will be available immediately and indefinitely following primary outcome manuscript publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Medically Unexplained Symptoms
Anxiety Disorders
Pathologic Processes
Mental Disorders
Signs and Symptoms