PCBH With the Addition of Self-help CBT

NCT ID: NCT04411771

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-04
• Study Completion Date: 2020-06-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Extended Assessment - Given shCBT

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

Group Type: EXPERIMENTAL

Guided self-help CBT

Intervention Type: BEHAVIORAL

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 shCBT will need four days of reading and two days of training to be able to make initial assessments and problem profiling and use the self-help books.

Screening Assessment - Suitable for shCBT but given BI

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.

Group Type: ACTIVE_COMPARATOR

Brief interventions

Intervention Type: BEHAVIORAL

'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 MI. The common theme is that they are principle-based rather than manual-based and focus on behavioral change in relation to a problem that is perceived both possible to affect and relevant to the patient, rather than focusing on a specific diagnosis or condition. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. Usually a BI treatment consists of 1-4 appointments with several weeks apart and ends when the patient feels that they are moving in the right direction.

Extended Assessment - All patients

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

Group Type: EXPERIMENTAL

Brief interventions

Intervention Type: BEHAVIORAL

'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 MI. The common theme is that they are principle-based rather than manual-based and focus on behavioral change in relation to a problem that is perceived both possible to affect and relevant to the patient, rather than focusing on a specific diagnosis or condition. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. Usually a BI treatment consists of 1-4 appointments with several weeks apart and ends when the patient feels that they are moving in the right direction.

Guided self-help CBT

Intervention Type: BEHAVIORAL

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 shCBT will need four days of reading and two days of training to be able to make initial assessments and problem profiling and use the self-help books.

Screening Assessment - All patients

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.

Group Type: ACTIVE_COMPARATOR

Brief interventions

Intervention Type: BEHAVIORAL

'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 MI. The common theme is that they are principle-based rather than manual-based and focus on behavioral change in relation to a problem that is perceived both possible to affect and relevant to the patient, rather than focusing on a specific diagnosis or condition. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. Usually a BI treatment consists of 1-4 appointments with several weeks apart and ends when the patient feels that they are moving in the right direction.

Interventions

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 MI. The common theme is that they are principle-based rather than manual-based and focus on behavioral change in relation to a problem that is perceived both possible to affect and relevant to the patient, rather than focusing on a specific diagnosis or condition. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. Usually a BI treatment consists of 1-4 appointments with several weeks apart and ends when the patient feels that they are moving in the right direction.

Intervention Type: BEHAVIORAL

Guided 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 shCBT will need four days of reading and two days of training to be able to make initial assessments and problem profiling and use the self-help books.

Intervention Type: BEHAVIORAL

Other Intervention Names

Focused interventions, brief CBT, focused Acceptance and Commitment Therapy, FACT, focused ACT; Self-help books, bibliotherapy, self-help CBT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kronoberg County Council

OTHER_GOV

Sponsor Role: collaborator

Capio Group

OTHER

Sponsor Role: collaborator

Linnaeus University

OTHER

Sponsor Role: lead

Responsible Party

Viktor Kaldo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viktor Kaldo, Professor

Role: PRINCIPAL_INVESTIGATOR

Linnaeus University

Locations

Vårdcentralen Centrum

Vaxjo, Kronoberg County, Sweden

Capio Citykliniken Västra Hamnen

Malmo, Skåne County, Sweden

Countries

Sweden

Other Identifiers

2019-00699

Identifier Type: -

Identifier Source: org_study_id