Clinical trial NCT04900064: Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: The Kamprad Family Foundation for Entrepreneurship, Research & Charity
name: Capio Group
name: Karolinska Institutet
First posted: 2021-05-25
Enrollment: 1242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomised between a diagnostic assessment and a contextual assessment. Patients in the contextual assessment arm can only be treated with brief interventions whereas patients in the diagnostic assessment arm are offered guided self-help if deemed appropriate and otherwise gets brief interventions.

As such, patients are randomised between two arms. We have however included four arms below in order to be able to describe the primary and secondary analysis. The primary analysis is performed on all patients treated with self-help CBT in the arm where a diagnostic assessment is made, compared to patients in the contextual assessment arm that are found suitable for self-help CBT (based on screening data), but treated with brief interventions.
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary outcomes:
measure: WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Patient Health Questionnaire 9-Item (PHQ-9)
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Patient Health Questionnaire 2-Item (PHQ-9)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Generalized Anxiety Disorder 2-item (GAD-2)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Social Phobia Inventory - Abbreviated version (Mini-SPIN)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Karolinska Exhaustion Disorder Scale 3-item (KEDS-3) + 2 confirming questions from s-UMS
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Perceived Stress Scale (PSS-MINI-2) + 2 new questions
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Insomnia Severity Index 2-item (ISI-MINI-2)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Short Health Anxiety Inventory 3-item (SHAI-MINI-3)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Pain One-item Rating
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Total symptom index
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Brunnsviken Brief Quality of Life Questionnaire (BBQ)
timeFrame: Change during the period Pre, Week 12 and 1 year
measure: Outcome Rating Scale (ORS)
timeFrame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
measure: Session Rating Scale (SRS)
timeFrame: Week 4, Week 8, Week 12 and 1 year
measure: One item Clinical Global Impression - Improvement (CGI-I)
timeFrame: After every session during week 1-12
measure: Patient-rated perception and attitude toward care provider
timeFrame: Week 12
measure: Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record
timeFrame: Week 12
measure: Patient recollection of plan/goal/methods, descriptions of behaviour changes made
timeFrame: Week 12
measure: Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause
timeFrame: Week 12
measure: Adverse Events-9
timeFrame: Week 12
measure: Adverse Events-3
timeFrame: Week 4, Week 8
measure: Well-being Behaviours-11
timeFrame: Change during the period Pre, Week 12 and 1 year
Other outcomes:
measure: Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
timeFrame: Pre, Week 12, 1 year
measure: Average waiting time
timeFrame: At first visit
measure: Supply of bookable appointments
timeFrame: Weekly from study start up to 2 years
measure: Third next available appointment (TNAA)
timeFrame: Weekly from study start up to 2 years
measure: Future capacity
timeFrame: Weekly from study start up to 2 years
measure: Number of visits and phone / video contacts during treatment duration
timeFrame: All visits during Pre-Week 12
measure: Average visit length
timeFrame: All visits during Pre-Week 12
measure: Percentage of patients presenting with a new primary reason for visit or more than 6 months since last visit
timeFrame: Daily from study start up to 2 years
measure: The number of patients seen per full time equivalent mental health professional for at least one visit in relation to all patients listed at the PCC
timeFrame: Monthly from study start up to 2 years
measure: The number of patients seen per full time equivalent mental health professional for at least one visit in relation to all patients with an ICD-10 diagnosis of F10-99, R40-45 or Z55-65
timeFrame: Monthly from study start up to 2 years
measure: Integrated Behaviours in Primary Care - Psychosocial Resource Edition (IBPC-PSR)
timeFrame: Pre, 6 months, 1 year
measure: Levels of Integration Measure, Swedish version (S-LIM)
timeFrame: Pre, 6 months, 1 year
measure: Integrated Behaviours in Primary Care - Registered Nurse Edition (IBPC-RN)
timeFrame: Pre, 6 months, 1 year
measure: Integrated Behaviours in Primary Care - GP Edition (IBPC-GP)
timeFrame: Pre, 6 months, 1 year
measure: Self-help CBT fidelity
timeFrame: Pre, 6 months, 1 year
measure: Attitudes to brief interventions
timeFrame: Pre, 6 months, 1 year
measure: Attitudes to self-help CBT
timeFrame: Pre, 6 months, 1 year
measure: Implementation success of PCBH
timeFrame: Pre, 6 months, 1 year
Locations:
city: Varberg
country: Sweden
facility: Vårdcentralen Västra Vall
state: Halland
city: Malmö
country: Sweden
facility: Capio Citykliniken Västra Hamnen
state: Skåne
city: Stockholm
country: Sweden
facility: Boo vårdcentral
city: Uppsala
country: Sweden
facility: Capio Vårdcentral Sävja
Study officials:
affiliation: Linnaeus University, Karolinska Institutet
name: Viktor Kaldo, Professor
role: PRINCIPAL_INVESTIGATOR
References: