Clinical trial NCT04411771: PCBH With the Addition of Self-help CBT
Official title: Evaluation of PCBH in Primary Care With or Without Additions of Guided Self-help CBT - a Single-blind Randomised Clinical Trial and Preparation for a Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Quality of Life
Psychological Distress
Activities, Daily Living
Insomnia
Stress
Keywords: PCBH
Primary Care Behavioral Health
Integrated Behavioural Health
Primary Care Mental Health Services
Primary Care
Brief Interventions
Focused Acceptance and Commitment Therapy
Brief CBT
IBH
CBT
Self-help
Guided Self-help
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: Kronoberg County Council
name: Capio Group
First posted: 2020-06-02
Enrollment: 69
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 an extended assessment and a screening assessment. Patients in the screening assessment arm can only be treated with brief interventions whereas patients in the extended assessment arm are offered guided self-help if deemed appropriate and otherwise gets brief interventions.

Patients are thus randomized to two arms, however we have included four arms in order to be able to describe the primary and secondary analysis. The primary is performed on all patients treated with shCBT in the arm where an extended assessment is made, compared to patients in the screening assessment arm that is found suitable for shCBT (base on screening data), but treated with brief interventions.
Primary purpose: TREATMENT

Brief summary: The overarching goal of primary care is to offer all patients individualized and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that many patients suffer from mental health problems, while there is a lack of psychosocial resources as well as clear pathways for these patients.

Primary care behavioural health (PCBH, in Swedish IBH) is an innovative way of organizing primary care, where psychosocial resources have more and shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients with achieving relevant behavior changes, so called Brief Interventions are used. However, these interventions have not been systematically evaluated in the same way that CBT has, and there is a risk that patients that would have benefitted from structured CBT are undertreated.

This study is a pilot study preparing for a large multicenter study that will be conducted starting in late 2020. The investigators want to find out if an addition of an extended evaluation and possibility of treatment with guided CBT self-help can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH with a contextual assessment and brief interventions. In the process, the investigators are also conducting one of the first RCT on brief interventions. As this is a pilot study, the feasibility of implementing the study protocol in regular healthcare is also tested in order to collect high-quality data while creating minimal disturbance in the centers' ordinary routines.

PCBH has the potential to increase the quality of care for patients with mental health problems. This study is the first to step towards answering the question if the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implemented treatments can increase them.

Detailed description: The overarching goal of primary care is to offer all patients individualized and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that many patients suffer from mental health problems, while there is a lack of psychosocial resources as well as clear pathways for these patients.

Primary care behavioural health (PCBH, in Swedish IBH) is an innovative way of organizing primary care, where psychosocial resources have more and shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients with achieving relevant behavior changes, so called Brief Interventions are used. However, these interventions have not been systematically evaluated in the same way that CBT has, and there is a risk that patients that would have benefitted from structured CBT are undertreated.

This study is a pilot study preparing for a large multicenter study that will be conducted starting in late 2020. The investigators want to find out if an addition of an extended evaluation and possibility of treatment with guided CBT self-help can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH with a contextual assessment and brief interventions. In the process, the investigators are also conducting one of the first RCT on brief interventions. As this is a pilot study, the feasibility of implementing the study protocol in regular healthcare is also tested in order to collect high-quality data while creating minimal disturbance in the centers' ordinary routines.

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?

The project is a joint effort by Karolinska Institutet, Linnaeus University, and Capio Närsjukvård and will be conducted as a single-blind (patients) randomized trial within regular healthcare at two primary care centres with a total of approximately 75 patients. Time-points for measures are screening at the initial visit and follow-ups 4, 8 and 52 weeks later. Primary outcome will be the 12-item version of the WHO Disability Assessment Schedule 2.0 (WHODAS-12). This is a condition-independent measure of everyday functioning that has been found to be relevant to mental health.

PCBH has the potential to increase the quality of care for patients with mental health problems. This study is the first to step towards answering the question if the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implemented treatments can increase them. Our study will also answer whether the effects can be increased by adding previously empirically supported self-help, while still being cost-effective and maintain high availability of services. The goal is to create a more solid empirical base that can guide decision makers when they balance treatment effects, availability, and costs in determining which organizational models and interventions that are best used in primary care.

If the results are positive, this project functions as a concrete start to a large-scale implementation of this new method, since it is firmly placed within regular primary care and uses highly implementable interventions.

Eligibility criteria: Inclusion Criteria:

* All patients from age 18 deemed to be suitable for Behavioral Health interventions, 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.
* 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-Week4-Week8
Secondary outcomes:
measure: WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Patient Health Questionnaire 2-Item (PHQ-2)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Generalized Anxiety Disorder 2-Item (GAD-2)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Social Phobia Inventory - Abbreviated version (Mini-SPIN)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Shirom-Melamed Burnout Questionnaire 2-item (SMBQ-MINI-2)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Perceived Stress Scale (PSS-MINI-2)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Insomnia Severity Index 2-item (ISI-MINI-2)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Short Health Anxiety Inventory 3-item (SHAI-MINI-3)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Pain One-item Rating
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Total symptom index
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Brunnsviken Brief Quality of Life Questionnaire
timeFrame: Change during the period Pre-Week4-Week8-Week 52
measure: Patient-rated problem severity, Confidence in ability to change, and Helpfulness of visit
timeFrame: Change from visit to visit through study completion (average of 8 weeks)
measure: One item Clinical Global Impression - Improvement (CGI-I)
timeFrame: 4 weeks, 8 weeks
measure: Patient-rated perception and attitude toward care provider
timeFrame: 4 weeks, 8 weeks
measure: Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record
timeFrame: 4 weeks, 8 weeks, 52 weeks
measure: Patient recollection of plan/goal/methods, descriptions of behaviour changes made
timeFrame: 4 weeks, 8 weeks, 52 weeks
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: 4 weeks, 8 weeks, 52 weeks
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Vårdcentralen Centrum
state: Kronoberg
city: Malmö
country: Sweden
facility: Capio Citykliniken Västra Hamnen
state: Skåne
Study officials:
affiliation: Linnaeus University
name: Viktor Kaldo, Professor
role: PRINCIPAL_INVESTIGATOR
References: