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
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Robert E Brady, PhD||Dartmouth-Hitchcock Medical Center|