Evaluating the impact of self-help CBT in primary care behavioral health
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
Run by Linnaeus University · NCT04900064 · Data updated 2026-11-12
This study is testing if adding guided self-help therapy to regular mental health care can help patients feel better and improve their daily lives.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1242 (estimated) |
| Sponsor | Linnaeus University Academic / other |
| Locations | 4 sites (Varberg, Halland County and 3 other locations) |
| Status | Recruiting |
| Started | June 14, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | April 11, 2025 |
| Trial ID | NCT04900064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older seeking care for mental health issues at participating primary care centers.
✕Probably not a fit
Patients requiring emergency care for severe mental health crises, such as suicidal ideation or ongoing psychosis, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter trial aims to assess whether adding a diagnostic assessment and guided self-help Cognitive Behavioral Therapy (CBT) can enhance the effectiveness of Primary Care Behavioral Health (PCBH) interventions for patients with mental health issues. The study will compare the outcomes of patients receiving standard PCBH, which focuses on contextual assessments and brief interventions, to those receiving the enhanced approach. The goal is to improve patient functioning and symptoms while also evaluating the overall impact on both patient and organizational outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health treatment outcomes for patients in primary care settings.
How similar studies have gone: Other studies have shown promise in integrating behavioral health interventions in primary care, but the specific combination of PCBH with self-help CBT is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, 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 or to receive self-help CBT in Swedish. * Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.
Where it's running
-
Capio Citykliniken Västra Hamnen
Malmö, Skåne County, Sweden Recruiting -
Capio Vårdcentral Sävja
Uppsala, Uppsala County, Sweden Recruiting -
Vårdcentralen Västra Vall
Varberg, Halland County, Sweden Not yet recruiting -
Boo vårdcentral
Stockholm, Stockholm County, Sweden Not yet recruiting
Study contacts
- Principal investigator: Viktor Kaldo, Professor — Linnaeus University, Karolinska Institutet
- Study coordinator: Anneli Farnsworth von Cederwald
- Email: anneli.farnsworthvoncederwald@lnu.se
- Phone: +46722372300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.