Evaluating the impact of self-help CBT in primary care behavioral health
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
NA · Linnaeus University · NCT04900064
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Linnaeus University (other) |
| Locations | 4 sites (Varberg, Halland County and 3 other locations) |
| Trial ID | NCT04900064 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older seeking care for mental health issues at participating primary care centers.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Varberg, Halland County and 3 other locations
- Vårdcentralen Västra Vall — Varberg, Halland County, Sweden (NOT_YET_RECRUITING)
- Capio Citykliniken Västra Hamnen — Malmö, Skåne County, Sweden (RECRUITING)
- Boo vårdcentral — Stockholm, Stockholm County, Sweden (NOT_YET_RECRUITING)
- Capio Vårdcentral Sävja — Uppsala, Uppsala County, Sweden (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Panic Disorder, Social Anxiety Disorder, Depression, Hypochondriasis, Insomnia, Generalized Anxiety Disorder, Burnout, Adjustment Disorders