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

Study Overview
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Brief Summary
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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
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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: 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? 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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Behavioral: Brief interventions
* Behavioral: Self-help CBT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic Assessment - Given self-help CBT<br>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. | Behavioral: Self-help CBT<br>* 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.<br>* Other names: Bibliotherapy, iCBT, Internet-Based Cognitive Behavioural Therapy, Blended Treatment, Self-help books;|
| Active Comparator: Contextual Assessment - Suitable for self-help CBT but given brief interventions<br>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. | Behavioral: Brief interventions<br>* '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.<br>* Other names: Focused CBT, focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy;|
| Experimental: Diagnostic Assessment - All patients<br>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. | Behavioral: Brief interventions<br>* '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.<br>* Other names: Focused CBT, focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy;Behavioral: Self-help CBT<br>* 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.<br>* Other names: Bibliotherapy, iCBT, Internet-Based Cognitive Behavioural Therapy, Blended Treatment, Self-help books;|
| Active Comparator: Contextual Assessment - All patients<br>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. | Behavioral: Brief interventions<br>* '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.<br>* Other names: Focused CBT, focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Patient recollection of plan/goal/methods, descriptions of behaviour changes made | Interview form. | Week 12 | 
| 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 | 
| Adverse Events-9 | 9 items asking patients to detail any adverse events that occurred as a result of treatment. | Week 12 | 
| Adverse Events-3 | 3 items asking patients to detail any adverse events that occurred as a result of treatment. | Week 4, Week 8 | 
| 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 |