PCBH With the Addition of Self-help CBT

L

Linnaeus University

Status

Completed

Conditions

Quality of Life
Depression, Anxiety
Insomnia
Activities, Daily Living
Stress
Psychological Distress

Treatments

Behavioral: Guided self-help CBT
Behavioral: Brief interventions

Study type

Interventional

Funder types

Other

Identifiers

NCT04411771
2019-00699

Details and patient eligibility

About

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.

Full 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: 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? 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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

69 participants in 4 patient groups

Extended Assessment - Given shCBT
Experimental group
Description:
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
Treatment:
Behavioral: Guided self-help CBT
Screening Assessment - Suitable for shCBT but given BI
Active Comparator group
Description:
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.
Treatment:
Behavioral: Brief interventions
Extended Assessment - All patients
Experimental group
Description:
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
Treatment:
Behavioral: Brief interventions
Behavioral: Guided self-help CBT
Screening Assessment - All patients
Active Comparator group
Description:
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.
Treatment:
Behavioral: Brief interventions

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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