Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief interventions, Self-help CBT.
- Who it may be relevant to
- Registry conditions: Panic Disorder, Social Anxiety Disorder, Depression, Hypochondriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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 rath - 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
Primary outcome measures
- WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
Secondary outcome measures (12)
- WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- Patient Health Questionnaire 9-Item (PHQ-9) [Time frame: Change during the period Pre, Week 12 and 1 year]
- Patient Health Questionnaire 2-Item (PHQ-9) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- Generalized Anxiety Disorder 7-item (GAD-7) [Time frame: Change during the period Pre, Week 12 and 1 year]
- Generalized Anxiety Disorder 2-item (GAD-2) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- Social Phobia Inventory - Abbreviated version (Mini-SPIN) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2) [Time frame: 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 [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- Perceived Stress Scale (PSS-MINI-2) + 2 new questions [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- Insomnia Severity Index 2-item (ISI-MINI-2) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
- Short Health Anxiety Inventory 3-item (SHAI-MINI-3) [Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year]
Eligibility criteria
Inclusion criteria
- All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and/or clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.
Exclusion criteria
- Does not speak Swedish well enough to fill out questionnaires or to receive self-help CBT in Swedish.
- Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 4 centers
- Vårdcentralen Västra Vall — Varberg
- Capio Citykliniken Västra Hamnen — Malmö
- Boo vårdcentral — Stockholm
- Capio Vårdcentral Sävja — Uppsala
Publications
- Farnsworth von Cederwald A, Salomonsson S, Hentati Isacsson N, Kaldo V. Evaluation of Primary Care Behavioral Health (PCBH) with guided self-help CBT as a treatment option - a protocol of a single-blind randomized multicenter trial (KAIROS). BMC Health Serv Res. 2025 Sep 23;25(1):1208. doi: 10.1186/s12913-025-13232-4. PMID 40988013
Identifiers
NCT: NCT04900064 · 2020-04198-A2