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

Linnaeus University

Status: Enrolling

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

Treatments: Behavioral: Self-help CBT; Behavioral: Brief interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT04900064

2020-04198-A2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,242 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,242 participants in 4 patient groups

Diagnostic Assessment - Given self-help CBT

Experimental group

Description:

The diagnostic assessment includes screening instruments, a structured interpretation of the screening instruments, a structured interview (MINI - International Neuropsychiatric Interview) and a medical anamnesis. If deemed appropriate, the patient can be offered treatment with guided self help. If the patient's problem is not deemed appropriate for this type of care or if the patient is not interested in guided self-help, they are offered brief interventions (BI). In the primary analysis, only patients receiving treatment with self-help CBT are included.

Treatment:

Behavioral: Self-help CBT

Contextual Assessment - Suitable for self-help CBT but given brief interventions

Active Comparator group

Description:

The contextual assessment includes screening instruments and a contextual interview. Patients in this arm will always be treated with brief interventions. In the primary analysis, only patients suitable for self-help CBT are included. This is decided by an algorithm based on data from their screening, which takes into account symptom severity and type, patient preference and known variables that make self-help CBT a worse fit.

Treatment:

Behavioral: Brief interventions

Diagnostic Assessment - All patients

Experimental group

Description:

Same as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they receive treatment with self-help CBT or brief interventions.

Treatment:

Behavioral: Brief interventions

Behavioral: Self-help CBT

Contextual Assessment - All patients

Active Comparator group

Description:

Same as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they are deemed suitable for self-help CBT or not.

Treatment:

Behavioral: Brief interventions