Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900064
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2021-05-12
Brief Title:
Evaluation of Primary Care Behavioral Health PCBH With the Addition of Self-help CBT - A Randomized Multicenter Trial
Sponsor:
Linnaeus University
Organization:
Linnaeus University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KAIROS
Brief 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
Detailed 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 patients 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 patients 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
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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None