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

Depression Clinical Trial

— KAIROS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900064
• Other study ID #: 2020-04198-A2
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Linnaeus University
• Contact: Anneli Farnsworth von Cederwald
• Phone: +46722372300
• Email: anneli.farnsworthvoncederwald[@]lnu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1242
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Capio Citykliniken Västra Hamnen	Malmö	Skåne
Sweden	Boo vårdcentral	Stockholm
Sweden	Capio Vårdcentral Sävja	Uppsala
Sweden	Vårdcentralen Västra Vall	Varberg	Halland

Sponsors (4)

Lead Sponsor	Collaborator
Linnaeus University	Capio Group, Karolinska Institutet, The Kamprad Family Foundation for Entrepreneurship, Research & Charity

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Inventory of Costs in Psychiatric Patients (TIC-P)	The TIC-P is a validated patient-reported outcome measure concerning the utilization of medical care and productivity losses. It does not have a minimum or maximum score but collects information that is needed for doing health economic calculations. This includes outcome measures such as amount of days on sick leave, productivity loss when at work, productivity loss at home, and medications prescribed and taken. Patient self-report will be complemented with register-level data on sick leave and medications.	Pre, Week 12, 1 year
Other	Average waiting time	- Average waiting time from the identification of a behavioural health concern to being seen by any clinician among patients in the study	At first visit
Other	Supply of bookable appointments	Amount of bookable times per week and full time psychosocial resources (personnel in training counted as 75% of full time), an indirect measure of availability to psychosocial resources	Weekly from study start up to 2 years
Other	Third next available appointment (TNAA)	Waiting time until next available appointment for a third hypothetical patient that calls in on a given day for every clinician at the PCC, measured on the same time every week (e. g. Mondays at 9 AM), a measure of access to and and availability of care	Weekly from study start up to 2 years
Other	Future capacity	Number of available time slots for appointments in the coming 4 weeks divided by total number of time slots in the caregiver's calendar, an indirect measure of availability	Weekly from study start up to 2 years
Other	Number of visits and phone / video contacts during treatment duration	Average number of visits per treatment, averaged across groups	All visits during Pre-Week 12
Other	Average visit length	Average length of visits with psychosocial resources, averaged across groups	All visits during Pre-Week 12
Other	Percentage of patients presenting with a new primary reason for visit or more than 6 months since last visit	An indirect measure of reach of psychosocial interventions	Daily from study start up to 2 years
Other	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	A measure of reach of psychosocial interventions	Monthly from study start up to 2 years
Other	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	A measure of reach of psychosocial interventions	Monthly from study start up to 2 years
Other	Integrated Behaviours in Primary Care - Psychosocial Resource Edition (IBPC-PSR)	To measure PCBH fidelity and competence among psychosocial resources; This questionnaire is not yet validated and has been created by the research group, as previously existing questionnaires have been difficult to apply to the Swedish healthcare system. The questionnaires will be validated parallel to this study. The scales include subscales to measure several specific areas of interest, such as collaboration between psychosocial resources and medical personnel.	Pre, 6 months, 1 year
Other	Levels of Integration Measure, Swedish version (S-LIM)	To measure PCBH fidelity and competence among leaders; This questionnaire is not yet validated and has been created by the research group, as previously existing questionnaires have been difficult to apply to the Swedish healthcare system. The questionnaires will be validated parallel to this study. The scales include subscales to measure several specific areas of interest, such as collaboration between psychosocial resources and medical personnel.	Pre, 6 months, 1 year
Other	Integrated Behaviours in Primary Care - Registered Nurse Edition (IBPC-RN)	To measure PCBH fidelity and competence among nurses; This questionnaire is not yet validated and has been created by the research group, as previously existing questionnaires have been difficult to apply to the Swedish healthcare system. The questionnaires will be validated parallel to this study. The scales include subscales to measure several specific areas of interest, such as collaboration between psychosocial resources and medical personnel.	Pre, 6 months, 1 year
Other	Integrated Behaviours in Primary Care - GP Edition (IBPC-GP)	To measure PCBH fidelity and competence among doctors; This questionnaire is not yet validated and has been created by the research group, as previously existing questionnaires have been difficult to apply to the Swedish healthcare system. The questionnaires will be validated parallel to this study. The scales include subscales to measure several specific areas of interest, such as collaboration between psychosocial resources and medical personnel.	Pre, 6 months, 1 year
Other	Self-help CBT fidelity	11 questions created by an expert group measuring fidelity to self-help CBT treatment.	Pre, 6 months, 1 year
Other	Attitudes to brief interventions	The AIM-IAM-FIM measurement with the three subscales Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM) to measure implementation constructs acceptability, appropriateness and feasibility of PCBH implementation	Pre, 6 months, 1 year
Other	Attitudes to self-help CBT	The AIM-IAM-FIM measurement with the three subscales Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM) to measure implementation constructs acceptability, appropriateness and feasibility of self-help CBT implementation	Pre, 6 months, 1 year
Other	Implementation success of PCBH	The original British instrument the Normalization Process Theory Measure (NoMAD) is based on the four core constructs of the Normalization Process Theory: Coherence, Cognitive Participation, Collective Action, and Reflexive Monitoring. They represent ways of thinking about implementation and are focused on how interventions can become part of everyday practice. The s-NoMAD is the validated Swedish version of the NoMAD.	Pre, 6 months, 1 year
Primary	WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)	The four domains of Life activities, Cognition, Getting along, and Participation. In the 12-item version of the WHO Disability Assessment Schedule 2.0 (WHODAS-12) will be used as primary outcome, since these are condition-independent measures of Behavioral Health relevant everyday functioning. The scale ranges from 0 to 32 points. A lower score means better functioning. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)	The two domains of Mobility and Self-care will be measured and the whole WHODAS will be used in some secondary analyses, but not for the primary outcome since these domains tend to form two independent factors, many patients will have initial adequate function in these domains and they are not expected to change much. The scale ranges from 0 to 48 points. A lower score means better functioning. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Patient Health Questionnaire 9-Item (PHQ-9)	The full version of a well-validated scale for measuring depressive symptoms. PHQ-9 total score for the nine items ranges from 0 to 27. A lower score means less depressive symptoms. As such, a lower score is a better outcome.	Change during the period Pre, Week 12 and 1 year
Secondary	Patient Health Questionnaire 2-Item (PHQ-9)	PHQ-2 consists of two questions from the PHQ-9. This will be administered as part of the PHQ-9 on the above mentioned time points, and will replace the PHQ-9 on the mid-treatment measurements. The scale ranges from 0 to 6 points. A lower score means less depressive symptoms. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Generalized Anxiety Disorder 7-item (GAD-7)	The full version of a well-validated scale for measuring anxiety symptoms. GAD-7 total score for the seven items ranges from 0 to 21. A lower score means less anxiety symptoms. As such, a lower score is a better outcome.	Change during the period Pre, Week 12 and 1 year
Secondary	Generalized Anxiety Disorder 2-item (GAD-2)	GAD-2 consists of two questions from the GAD-7. This will be administered as part of the GAD-7 on the above mentioned time points, and will replace the GAD-7 on the mid-treatment measurements. The scale ranges from 0 to 6 points. A lower score means less anxiety symptoms. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Social Phobia Inventory - Abbreviated version (Mini-SPIN)	Social anxiety symptoms are measured with a very short version of a well established patient-rated scale for social phobia. The scale ranges from 0 to 12 points. A lower score means less symptoms of social anxiety. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)	Symptoms of alcohol misuse are measured with a very short version of a well established patient-rated scale for alcohol misuse. The scale ranges from 0 to 12 points. A lower score means less symptoms of alcohol misuse. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)	Symptoms of panic attacks are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 8 points. A lower score means less symptoms of panic disorder. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Karolinska Exhaustion Disorder Scale 3-item (KEDS-3) + 2 confirming questions from s-UMS	Symptoms of stress-related exhaustion are measured with a very short version of a well established patient-rated scale and has been created by an expert group, who chose three representative questions from the original KEDS scale. To aid with diagnostics, two confirmatory questions from the Swedish s-UMS scale were added, asking for duration and presumed cause of symptoms. The scale ranges from 0 to 18 points. A lower score means less symptoms of stress-related exhaustion. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Perceived Stress Scale (PSS-MINI-2) + 2 new questions	Stress symptoms are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. To increase face validity of the very short scale, we also added two more direct questions ("Have you been feeling stressed lately?", "Have you been feeling tense lately?"). The scale ranges from 0 to 16 points. A lower score means less stress symptoms. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Insomnia Severity Index 2-item (ISI-MINI-2)	Symptoms of sleep disorders are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 8 points. A lower score means less sleep problems. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Short Health Anxiety Inventory 3-item (SHAI-MINI-3)	Symptoms of health anxiety are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 9 points. A lower score means less symptoms of health anxiety. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)	Symptoms of obsessive compulsive disorder are measured by a very short patient-rated scale and has been created by an expert group. The scale ranges from 0 to 12 points. A lower score means less obsessive/compulsive thoughts and behaviors. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Pain One-item Rating	Pain is measured on a scale from 0 to 10, where 0 is no pain and 10 is worst pain imaginable. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Total symptom index	Also, a total index for level of symptoms will be calculated from all symptom items, where different weights will be used to balance the different number of questions for different domains, for example to avoid the larger number of items related to anxiety to overshadow depression ratings. The scale ranges from 0 to 20 points. A lower score means less mental health symptoms overall. As such, a lower score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Brunnsviken Brief Quality of Life Questionnaire (BBQ)	Quality of life will be measure be the 12-item Brunnsviken Brief Quality of life (BBQ-12), asking about importance and fulfilment of six areas (e.g. spare time quality, creative work, and friendship). The scale ranges from 0 to 96 points. A lower score means lower quality of life. As such, a higher score is a better outcome.	Change during the period Pre, Week 12 and 1 year
Secondary	Outcome Rating Scale (ORS)	The ORS is a four-item measure designed to assess areas of life functioning known to change as a result of therapeutic intervention. These include symptom distress, interpersonal well-being, social role, and overall well-being, measured by four visual analogue scales. The scale ranges from 0 to 40 points. A lower score means lower satisfaction with life areas. As such, a higher score is a better outcome.	Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary	Session Rating Scale (SRS)	The Session Rating Scale (SRS) is a four-item visual analogue scale designed to assess key dimensions of effective therapeutic relationships. These include respect and understanding, relevance of the goals and topics, client-practitioner fit and overall alliance. The scale ranges from 0 to 40 points. A lower score means lower ratings of the therapeutic alliance. As such, a higher score is a better outcome.	Week 4, Week 8, Week 12 and 1 year
Secondary	One item Clinical Global Impression - Improvement (CGI-I)	Related to main problem seeking care for as rated by clinician. The scale ranges from 0 to 7 points. A lower score means a larger improvement for the patient. As such, a lower score is a better outcome.	After every session during week 1-12
Secondary	Patient-rated perception and attitude toward care provider	9-items previously used in PCBH-settings (self-report), and four items from the Client Satisfaction Questionnaire (CSQ). The scale ranges from 0 to 57 points. A lower score means less satisfaction with care. As such, a higher score is a better outcome.	Week 12
Secondary	Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record	Interview form.	Week 12
Secondary	Patient recollection of plan/goal/methods, descriptions of behaviour changes made	Interview form.	Week 12
Secondary	Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause	Interview form.	Week 12
Secondary	Adverse Events-9	9 items asking patients to detail any adverse events that occurred as a result of treatment.	Week 12
Secondary	Adverse Events-3	3 items asking patients to detail any adverse events that occurred as a result of treatment.	Week 4, Week 8
Secondary	Well-being Behaviours-11	11 items asking patients how often they engage in behaviours related to maintaining physical and mental well-being, such as physical exercise and having adequate sleep hygiene.	Change during the period Pre, Week 12 and 1 year