Actively Recruiting
Led by Linnaeus University · Updated on 2025-04-11
1242
Participants Needed
4
Research Sites
52 weeks
Total Duration
L
Linnaeus University
Lead Sponsor
T
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Collaborating Sponsor
Researchers are evaluating whether adding a diagnostic assessment and the option of guided self-help Cognitive Behavioral Therapy (CBT) to Primary Care Behavioral Health (PCBH) can improve patient functioning and symptoms compared to standard PCBH that uses contextual assessments and brief interventions. The study also investigates the overall impact of PCBH on outcomes for both patients and healthcare organizations. This multicenter trial focuses on patients with various mental and behavioral health problems, aiming to address challenges in primary care related to mental health treatment access and quality. Participants will be randomly assigned to either standard PCBH, which involves contextual assessments and brief interventions based on psychological treatment components like CBT and Acceptance and Commitment Therapy, or to an extended PCBH version with diagnostic assessments and the possibility of self-help CBT. The diagnostic assessment includes structured interviews and screening instruments, and if suitable, patients receive guided self-help CBT using scientifically evaluated self-help books supported by therapist contacts. Brief interventions involve 1-4 appointments focusing on behavioral changes and are delivered by trained clinicians. Treatment duration for self-help CBT ranges from 6 to 12 weeks with 3-6 therapist contacts, including in-person and remote support. Participants will complete various assessments throughout the study, including the WHO Disability Assessment Schedule 2.0 and several mental health questionnaires at multiple intervals up to one year. Researchers will monitor patient symptoms, functioning, quality of life, and treatment experiences, along with implementation outcomes like feasibility and satisfaction. Data on adverse events and behavioral changes will also be collected. The study aims to determine the effectiveness and practicality of integrating self-help CBT into PCBH for better mental health care in primary settings.
CONDITIONS
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks
Participants receive either brief interventions or guided self-help CBT depending on their assessment and suitability. Brief interventions involve 1 to 4 appointments focusing on behavioral change and are flexible in scheduling. Guided self-help CBT includes use of a CBT-based self-help book with 3 to 6 therapist contacts over 6 to 12 weeks, combining in-person and remote sessions.
3 to 6 contacts including 1 to 3 in-person visits and additional phone, video, or secure messaging sessions
Duration - Up to 1 year
Participants complete follow-up assessments to evaluate changes in symptoms, everyday function, and experiences up to 1 year after treatment.
Scheduled assessments at Week 4, Week 8, Week 12, and 1 year
Total: 4 locations
1
Vårdcentralen Västra Vall
Varberg, Halland County, Sweden
Not Yet Recruiting
2
Capio Citykliniken Västra Hamnen
Malmö, Skåne County, Sweden
Actively Recruiting
3
Boo vårdcentral
Stockholm, Stockholm County, Sweden
Not Yet Recruiting
4
Capio Vårdcentral Sävja
Uppsala, Uppsala County, Sweden
Actively Recruiting
A
Anneli Farnsworth von Cederwald
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Anneli Farnsworth von Cederwald, Sigrid Salomonsson, Nils Hentati Isacsson...
https://pubmed.ncbi.nlm.nih.gov/40988013