Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial for Superiority and Non-superiority Comparisons of Effects on Patients' Everyday Function, Symptoms, and Experiences

Brief Summary

Detailed Description

The overarching goal of primary care is to offer all patients individualised and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that a large proportion of patients suffer from mental and behavioural health problems, alone or in combination with one or several chronic illnesses. Despite many patients needing psychosocial interventions, there is a lack of mental health professionals as well as clear pathways for these patients. Primary Care Behavioural Health (PCBH) is an innovative way of organising primary care, where mental health professionals have more yet shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients achieve relevant behavioural changes, so called brief interventions are used, which are based on isolated components from psychological treatments such as Cognitive Behavioural Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Brief interventions usually stretch over 1-4 treatment sessions. Assessments within the model are generally contextual and largely avoid psychiatric diagnostics, instead focussing on the patient's situation and their associated coping strategies - whether they be positive or negative. However, these interventions have not been systematically evaluated in the same way that structured CBT has, and there is a risk that patients that would have benefitted from structured CBT and a diagnostic assessment are undertreated due to lack of diagnostics and the reduced visit duration and amount. Data will be collected at primary care centres (PCCs) that already have a high fidelity to a PCBH framework. Fidelity will be measured by an expert group as well as using four questionnaires, one for each of mental health professionals, medical doctors, registered nurses and leadership. These fidelity scales will be validated in a separate study. In addition to fidelity, work environment and satisfaction with the PCBH implementation will be measured. Patients at the centres will be randomised between receiving contextual assessments followed by brief interventions, or a diagnostic assessment, which can lead to treatment with either self-help CBT (if a treatable diagnosis is confirmed and the patient is suitable for self-help CBT) or brief interventions (if self-help CBT is not deemed to be a suitable intervention). The primary comparison is the outcome for patients who either received self-help CBT or are deemed suitable for the intervention based on screening data, while secondary analyses will look at treatment outcomes for all patients, including those with non-psychiatric problems such as crises, loss or work- or family-related problems. The study will also look at implementation outcomes for self-help CBT and diagnostic assessments to see if self-help CBT is a feasible addition to the PCBH model. Our main research questions are: 1. Does an extended version of PCBH, including an additional assessment and the option of guided self-help CBT when indicated by a patient's problem profile, lead to superior patient outcomes compared to standard PCBH where a brief, contextual assessment followed by Brief Interventions is the only option? If not, can standard PCBH be shown to be non-inferior? 2. Does the addition of guided self-help CBT have a negative effect on availability, reach, and cost-effectiveness compared to standard PCBH? If not, can guided self-help CBT be shown to be non-inferior to standard PCBH concerning these outcomes? PCBH has the potential to increase the quality and access of care for many patients with mental and behavioural health problems. This study is the first to step towards answering whether or not the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implementable treatments can increase the treatment effects.

Primary Outcomes

Secondary Outcomes

• Social Phobia Inventory - Abbreviated version (Mini-SPIN)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Insomnia Severity Index 2-item (ISI-MINI-2)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Patient Health Questionnaire 2-Item (PHQ-9)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Perceived Stress Scale (PSS-MINI-2) + 2 new questions(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Patient Health Questionnaire 9-Item (PHQ-9)(Change during the period Pre, Week 12 and 1 year)
• Generalized Anxiety Disorder 7-item (GAD-7)(Change during the period Pre, Week 12 and 1 year)
• Generalized Anxiety Disorder 2-item (GAD-2)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Karolinska Exhaustion Disorder Scale 3-item (KEDS-3) + 2 confirming questions from s-UMS(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Patient-rated perception and attitude toward care provider(Week 12)
• Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause(Week 12)
• Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Short Health Anxiety Inventory 3-item (SHAI-MINI-3)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Pain One-item Rating(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Total symptom index(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Brunnsviken Brief Quality of Life Questionnaire (BBQ)(Change during the period Pre, Week 12 and 1 year)
• Outcome Rating Scale (ORS)(Change during the period Pre, Week 4, Week 8, Week 12 and 1 year)
• Session Rating Scale (SRS)(Week 4, Week 8, Week 12 and 1 year)
• Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record(Week 12)
• Patient recollection of plan/goal/methods, descriptions of behaviour changes made(Week 12)
• One item Clinical Global Impression - Improvement (CGI-I)(After every session during week 1-12)
• Adverse Events-9(Week 12)
• Adverse Events-3(Week 4, Week 8)
• Well-being Behaviours-11(Change during the period Pre, Week 12 and 1 year)