PCBH With the Addition of Self-help CBT
- Conditions
- InsomniaStressQuality of LifePsychological DistressActivities, Daily LivingDepression, Anxiety
- Interventions
- Behavioral: Brief interventionsBehavioral: Guided self-help CBT
- Registration Number
- NCT04411771
- Lead Sponsor
- Linnaeus University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Screening Assessment - All patients Brief interventions Same as the other arm marked as "Active comparator", but for the purpose of a secondary analysis all patients randomized to Screening Assessment are included, regardless of if they are suiteble for shCBT or not. Extended Assessment - Given shCBT Guided self-help CBT The extended assessment includes screening instruments, a structured interpretation of the screening instruments, a structured 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 given shCBT are included Screening Assessment - Suitable for shCBT but given BI Brief interventions The screening assessment includes screening instruments and a contextual interview. Patients in this arm will always be treated with brief interventions. In the primary anaysis, only patients suited for shCBT are included, as decided from an algorithm based on data from their screening. Extended Assessment - All patients Guided self-help CBT Same as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomized to Extended Assessment are included, regardless of if they start shCBT or BI Extended Assessment - All patients Brief interventions Same as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomized to Extended Assessment are included, regardless of if they start shCBT or BI
- Primary Outcome Measures
Name Time Method WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains) Change during the period Pre-Week4-Week8 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.
- Secondary Outcome Measures
Name Time Method Insomnia Severity Index 2-item (ISI-MINI-2) Change during the period Pre-Week4-Week8-Week 52 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.
Obsessive Compulsive Disorder 3-Item (OCD-3-MINI) Change during the period Pre-Week4-Week8-Week 52 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.
Total symptom index Change during the period Pre-Week4-Week8-Week 52 Also, a total index for level of symptoms will be calculated from all 21 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.
Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record 4 weeks, 8 weeks, 52 weeks Interview form.
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument) Change during the period Pre-Week4-Week8-Week 52 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.
The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Change during the period Pre-Week4-Week8-Week 52 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.
Shirom-Melamed Burnout Questionnaire 2-item (SMBQ-MINI-2) Change during the period Pre-Week4-Week8-Week 52 Burnout 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. The scale ranges from 2 to 14 points. A lower score means less symptoms of burnout. As such, a lower score is a better outcome.
Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2) Change during the period Pre-Week4-Week8-Week 52 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.
Short Health Anxiety Inventory 3-item (SHAI-MINI-3) Change during the period Pre-Week4-Week8-Week 52 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.
Patient-rated perception and attitude toward care provider 4 weeks, 8 weeks 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.
Patient Health Questionnaire 2-Item (PHQ-2) Change during the period Pre-Week4-Week8-Week 52 Depressive symptoms are measured with a very short version of a well established patient-rated scale for depression. The scale ranges from 0 to 6 points. A lower score means less depressive symptoms. As such, a lower score is a better outcome.
Generalized Anxiety Disorder 2-Item (GAD-2) Change during the period Pre-Week4-Week8-Week 52 Anxiety and worry symptoms are measured with a very short version of a well established patient-rated scale for generalized anxiety disorder. The scale ranges from 0 to 6 points. A lower score means less anxiety and worry symptoms. As such, a lower score is a better outcome.
Social Phobia Inventory - Abbreviated version (Mini-SPIN) Change during the period Pre-Week4-Week8-Week 52 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.
Pain One-item Rating Change during the period Pre-Week4-Week8-Week 52 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.
Patient recollection of plan/goal/methods, descriptions of behaviour changes made 4 weeks, 8 weeks, 52 weeks Interview form.
Perceived Stress Scale (PSS-MINI-2) Change during the period Pre-Week4-Week8-Week 52 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. The scale ranges from 0 to 8 points. A lower score means less stress symptoms. As such, a lower score is a better outcome.
Brunnsviken Brief Quality of Life Questionnaire Change during the period Pre-Week4-Week8-Week 52 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.
Patient-rated problem severity, Confidence in ability to change, and Helpfulness of visit Change from visit to visit through study completion (average of 8 weeks) All rated from 1-10 by patient when asked by clinician. A lower score means lower symptoms / confidence / helpfulness. As such, a lower score is a better outcome for the symptom question but a worse outcome for the confidence and helpfulness questions.
Questions are administered at every visit. There is no set time frames as visits can have irregular spacing and different participants will have varying numbers of visits. These questions do not make up a validated scale, but are clinically used within Focused Acceptance and Commitment Therapy.One item Clinical Global Impression - Improvement (CGI-I) 4 weeks, 8 weeks 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.
Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause 4 weeks, 8 weeks, 52 weeks Interview form.
Trial Locations
- Locations (2)
Capio Citykliniken Västra Hamnen
🇸🇪Malmö, Skåne, Sweden
Vårdcentralen Centrum
🇸🇪Växjö, Kronoberg, Sweden