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.


Health anxiety is a chronic mental health condition that exerts substantial personal and economic burdens on patients, providers, and the larger healthcare system. Patients with health anxiety experience persistent worry and dread over the possibility that they are presently ill with an undetected or poorly defined physical illness or may soon become ill despite an absence of evidence and physician reassurance of wellness. A complication of health anxiety is that the sufferer frequently denies the presence of excessive anxiety, typically attributing their distress to an inability of the medical team to correctly identify the feared illness. As a result, these patients are challenging to engage in evidence-based psychosocial interventions. The present study protocol describes a psychosocial intervention based on cognitive-behavioral therapy that is adapted for delivery by Medical Assistants in the primary care setting. The rationale for this approach is that delivery by Medical Assistants has the potential to overcome barriers to engagement that prevent effective care. Moreover, deploying a task-shifted intervention relieves strain on the care team by sharing the responsibility for helping the patient manage health anxiety. The aim of this study is to demonstrate the effectiveness of this intervention and approach on health anxiety, while simultaneously collecting data on the barriers and facilitators of implementation, consistent with a hybrid type 1 study design. We will compare patient-level outcomes for participants randomized to the study intervention versus routine referral to mental health services and characterize the potential for implementation using qualitative data drawn from patient and clinical stakeholders.

Keywords: Cognitive-behavioral therapy; Effectiveness; Health anxiety; Implementation; Randomized clinical trial.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Anxiety / psychology
  • Anxiety / therapy
  • Anxiety Disorders / therapy
  • Cognitive Behavioral Therapy*
  • Humans
  • Primary Health Care
  • Psychosocial Intervention*
  • Randomized Controlled Trials as Topic