Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1242 (estimated)
SponsorLinnaeus University
Academic / other
Locations4 sites (Varberg, Halland County and 3 other locations)
StatusRecruiting
StartedJune 14, 2021
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedApril 11, 2025
Trial IDNCT04900064 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.