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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Sweden
Capio Citykliniken Västra Hamnen
RECRUITING
Malmo
Boo vårdcentral
NOT_YET_RECRUITING
Stockholm
Capio Vårdcentral Sävja
RECRUITING
Uppsala
Vårdcentralen Västra Vall
NOT_YET_RECRUITING
Varberg
Contact Information
Primary
Anneli Farnsworth von Cederwald
anneli.farnsworthvoncederwald@lnu.se
+46722372300
Time Frame
Start Date:2021-06-14
Estimated Completion Date:2026-12-31
Participants
Target number of participants:1242
Treatments
Experimental: Diagnostic Assessment - Given self-help CBT
The diagnostic assessment includes screening instruments, a structured interpretation of the screening instruments, a structured interview (MINI - International Neuropsychiatric Interview) and a medical anamnesis. If deemed appropriate, the patient can be offered treatment with guided self help. If the patient's problem is not deemed appropriate for this type of care or if the patient is not interested in guided self-help, they are offered brief interventions (BI).~In the primary analysis, only patients receiving treatment with self-help CBT are included.
Active_comparator: Contextual Assessment - Suitable for self-help CBT but given brief interventions
The contextual assessment includes screening instruments and a contextual interview. Patients in this arm will always be treated with brief interventions.~In the primary analysis, only patients suitable for self-help CBT are included. This is decided by an algorithm based on data from their screening, which takes into account symptom severity and type, patient preference and known variables that make self-help CBT a worse fit.
Experimental: Diagnostic Assessment - All patients
Same as the other arm marked as Experimental, but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they receive treatment with self-help CBT or brief interventions.
Active_comparator: Contextual Assessment - All patients
Same as the other arm marked as Experimental, but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they are deemed suitable for self-help CBT or not.