Study Comparing Primary Care Behavioral Health With Added Self-help CBT Versus Standard Care Assessing Effects on Patient Functioning, Symptoms, and Care Experience

What this Trial Is About

Researchers are evaluating whether adding a diagnostic assessment and the option of guided self-help Cognitive Behavioral Therapy CBT to Primary Care Behavioral Health PCBH can improve patient functioning and symptoms compared to standard PCBH that uses contextual assessments and brief interventions. The study also investigates the overall impact of PCBH on outcomes for both patients and healthcare organizations. This multicenter trial focuses on patients with various mental and behavioral health problems, aiming to address challenges in primary care related to mental health treatment access and quality. Participants will be randomly assigned to either standard PCBH, which involves contextual assessments and brief interventions based on psychological treatment components like CBT and Acceptance and Commitment Therapy, or to an extended PCBH version with diagnostic assessments and the possibility of self-help CBT. The diagnostic assessment includes structured interviews and screening instruments, and if suitable, patients receive guided self-help CBT using scientifically evaluated self-help books supported by therapist contacts. Brief interventions involve 1-4 appointments focusing on behavioral changes and are delivered by trained clinicians. Treatment duration for self-help CBT ranges from 6 to 12 weeks with 3-6 therapist contacts, including in-person and remote support. Participants will complete various assessments throughout the study, including the WHO Disability Assessment Schedule 2.0 and several mental health questionnaires at multiple intervals up to one year. Researchers will monitor patient symptoms, functioning, quality of life, and treatment experiences, along with implementation outcomes like feasibility and satisfaction. Data on adverse events and behavioral changes will also be collected. The study aims to determine the effectiveness and practicality of integrating self-help CBT into PCBH for better mental health care in primary settings.

Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial