NCT04900064

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,242 (estimated)
• Sponsor: Linnaeus University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.

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.

Conditions

• Panic Disorder
• Social Anxiety Disorder
• Depression
• Hypochondriasis
• Insomnia
• Generalized Anxiety Disorder
• Burnout
• Adjustment Disorders
• Stress, Psychological
• Obsessive-Compulsive Disorder
• Life Stress
• Life Style Induced Illness
• Psychological Distress

Interventions

Type	Name	Description
BEHAVIORAL	Brief interventions	'Brief Interventions' (BI) is a generic term for a multitude of tools and interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. As such, there is no separation between assessment and intervention. The interventions within BI often have their foundation in CBT, ACT or Motivational Interviewing (MI). The common theme is that they are principle-based rather than manual-based and focus on behavioural change in relation to a problem, rather than focusing on a specific diagnosis. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. A BI treatment usually consists of 1-4 appointments with several weeks apart and has an open ending, where the patient easily can schedule a new appointment. Clinicians delivering brief interventions will have had 3 days of training as well as regular supervision.
BEHAVIORAL	Self-help CBT	The patient receives a previously scientifically evaluated CBT-based self-help book for one of the following conditions: depression, generalized anxiety disorder, panic disorder, social anxiety, health anxiety, insomnia, or stress/burnout. The therapist support consists of 3-6 contacts throughout the 6-12 weeks long intervention period as decided by the clinician and patient together, as long as at least one and not more than three are physical visits at the center and the rest via phone, video conferencing, or secure internet messages. Clinicians delivering self-help CBT will need four days of reading and two days of training as well as regular supervision to be able to make initial assessments and problem profiling and use the self-help books.

Timeline

• Start date: 2021-06-14
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2021-05-25
• Last updated: 2025-04-11

Locations

4 sites across 1 country: Sweden