Clinical trial NCT03789084: Hybrid Trial of Brief Cognitive-Behavioral Therapy for Health Anxiety in Primary Care
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Illness Anxiety Disorder
Somatic Symptom Disorder
Health Anxiety
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-12-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Seventy-two health anxious patients with a diagnosis of Illness Anxiety Disorder or Somatic Symptom Disorder will be randomly assigned to either receive brief cognitive-behavioral therapy (CBT) administered by a medical assistant in the primary care practice where the patient receives their primary care services (intervention condition) or receive a referral to a mental health provider within the outpatient psychiatry clinic or another community provider of their choice (usual care condition). Randomization will be determined by a random number generation program at the point of enrollment. The randomization scheme will be stratified by primary care site to reduce site effects. The primary care sites from which patients will be recruited include the General Internal Medicine clinic at Dartmouth-Hitchcock Medical Center, Dartmouth-Hitchcock Heater Road clinic, and Dartmouth-Hitchcock Manchester. Recruitment will be evenly distributed across sites. The investigators will over-sample racial and ethnic minority patients at Dartmouth-Hitchcock Manchester due to the higher proportion of minority patients receiving services at that location.

The brief CBT intervention is a 4-session psychotherapy comprised of techniques guided by cognitive-behavioral theory and specifically derived from previously published materials. Each technique has support from prior randomized controlled trials demonstrating their efficacy for reducing symptoms of health anxiety and expert consensus. The techniques employed include motivational interviewing, psychoeducation, cognitive restructuring, and situational and interoceptive exposure. Each session of brief CBT is 45-minutes in duration and is delivered by a medical assistant who is principally located at the patient's primary care practice. All sessions are based on a manual developed by the Principal Investigator that includes essential elements to deliver at each session, scripts to guide delivery of the intervention, and homework assignments for the patient to complete between sessions and after completion of the final session. The Principal Investigator provides clinical supervision of the intervention over the course of the study.

The referral process employed in the usual care condition consists of an electronic referral made by the patient's primary care provider to a mental health provider within the Dartmouth-Hitchcock Health system, or a community provider outside of the system identified by the patient in consultation with the primary care provider. The nature of the intervention provided by the mental health provider is not prescribed or guided by the study protocol.

Examination of distributions of all variables using descriptive analyses will precede inferential statistical analysis. Transformations or recoding will be applied to normalize continuous data when necessary. The success of random assignment will be evaluated by comparing the two study groups on baseline characteristics using chi-square tests for categorical variables and t-tests for continuous covariates. If baseline variables are significantly different between groups and are significantly associated with the outcomes (e.g., medical comorbidity), the investigators will include them as covariates in the analytic models.

The primary outcome of change in health anxiety will be tested using a model that accommodates attrition and is appropriate for correlated data due to clustering (by 3 sites and 6 medical assistants) and repeated measures (baseline, 4 and 12 weeks) on the outcomes. Because there are only three assessment points, time will be treated as discrete and fitted to a covariance pattern model to compare average change between groups over time. Group (CBT vs usual care), time (baseline, 4 and 12 weeks), and the group by time interaction will be specified for the model. The treatment effect of intervention relative to control will be evaluated by testing significance of the group by time interaction term. An unstructured variance-covariance structure will be specified to account for the correlated nature of the data due to repeated measures.

The cluster size at site and provider levels are too small to be treated as random effects; therefore, the analysis will take clustering effects due to site and provider into account using small-sample robust estimate correction options implemented in the Statistical Analysis Software (SAS) generalized linear mixed models procedure (PROC GLIMMIX) procedure. GLIMMIX facilitates conducting mixed-effects and generalized estimating equation (GEE) modeling in the same procedure simultaneously.

The sample size was determined by a combination of recruitment feasibility, study therapist (medical assistant) availability, and power analysis. Given two groups, 3-assessment points, and sample size of 72 (36 per arm) with 15% attrition at 12 months (N = 58), and assuming cross-time correlation of 0.60, alpha of 0.05, and two-tailed tests, the study achieves 80% power to detect a minimum effect size of 0.69, between medium (0.50) and large (0.80) in Cohen's d-metric. If the analysis takes clustering effects due to site and providers into account by adjusting the sample size with an intraclass correlation (ICC) of 0.01, the study achieves 80% power to detect an effect size of 0.72. Statisticians recommend ICC between 0.01 and 0.02 in clinical studies with clustering; the investigators used ICC = 0.01 for this power calculation. A larger sample size is needed to detect effect sizes smaller than 0.69 and 0.72; however, sample size for pilot study should be based on pragmatics of recruitment and the necessities for examining feasibility, and not for purpose of inferential statistical tests.

The investigators will assess acceptability of the intervention and strategy using scores on a self-report measure of treatment acceptability using mean scores above a predetermined cut score denoting moderate acceptability across all participants. The investigators assess study therapist fidelity to the treatment by compiling standardized fidelity ratings for each session, nested within each provider, and converted to a percentage fidelity score.

Finally, the investigators will assess acceptability qualitatively using qualitative interviews with medical assistants, primary care providers, and clinic administrators. Interview data will be transcribed and entered verbatim into a qualitative data management software package for content analysis. Content analysis consists of reviewing the responses of interviewees to identify responses that are coded to correspond to Consolidated Framework for Implementation Research constructs. Coding will be conducted by two independent coders (the Principal Investigator and a research assistant) and overseen by a medical anthropologist.

Eligibility 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

Primary outcomes:
measure: Change from baseline in health anxiety, measured by the Short Health Anxiety Inventory
timeFrame: Baseline, Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup)
Secondary outcomes:
measure: Acceptability of the intervention, measured by the Treatment Evaluation Inventory-Short Form
timeFrame: Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup)
measure: Change in readiness for intervention, measured by the University of Rhode Island Change Assessment-Psychotherapy Version
timeFrame: Baseline, Post-treatment (4 weeks followup), 12-weeks Post-Treatment (12 weeks followup)
Other outcomes:
measure: Fidelity to the intervention following training, measured by the Cognitive Therapy Scale-Revised
timeFrame: 1 to 15 months before Baseline
measure: Psychiatric diagnostic comorbidity, assessed by the Mini-International Neuropsychiatric Interview
timeFrame: Baseline
measure: Medical diagnostic comorbidity, assessed by the Charlton Age-Comorbidity Index
timeFrame: Baseline
measure: Determination of health anxiety diagnoses, assessed by the Health Anxiety Interview
timeFrame: Baseline
measure: Measurement of health anxiety for screening purposes, assessed by the Whiteley Index-7
timeFrame: 1 week to 1 month before Baseline
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Robert E Brady, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.