RecruitingNot ApplicableNCT04900064

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

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


Sponsor

Linnaeus University

Enrollment

1,242 participants

Start Date

Jun 14, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether adding a self-guided cognitive behavioral therapy (CBT) program to standard behavioral health care at primary care clinics helps patients with mental health concerns. It is a multi-center study conducted in Sweden. **You may be eligible if...** - You are 18 years or older - You are a patient at a primary care clinic in Sweden seeking help for a mental health concern - Your healthcare provider has referred you to the behavioral health team at the clinic - You speak Swedish well enough to complete questionnaires and use the self-help program **You may NOT be eligible if...** - You do not speak Swedish sufficiently - You are in urgent need of care, such as having thoughts of suicide, or experiencing active psychosis or mania Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALBrief 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 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.

BEHAVIORALSelf-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 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.


Locations(4)

Vårdcentralen Västra Vall

Varberg, Halland County, Sweden

Capio Citykliniken Västra Hamnen

Malmö, Skåne County, Sweden

Boo vårdcentral

Stockholm, Stockholm County, Sweden

Capio Vårdcentral Sävja

Uppsala, Uppsala County, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04900064


Related Trials