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Early Interventions for Primary Care Patients With Stress-related Ill-health: a Non-inferiority RCT

NCT04820283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-09-15

No results posted yet for this study

Summary

Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Collaborative care has been shown to be an effective working model for primary care patients with mental health problems. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and therapist-guided self-help CBT -can be effective as early interventions for primary care patients with stress-related ill-health.

Conditions

  • Stress

Interventions

BEHAVIORAL

Care manager intervention (nurse)

In this intervention, a primary care nurse provides the participant with self-management support to manage stress-related problems. The participant meets with the nurse face-to-face for typically 2 to 6 sessions.

BEHAVIORAL

CBT

In this intervention, the participant receives therapist supported self-help CBT. The participant randomized to this arm can choose to receive the treatment via an online treatment platform or via bibliotherapy, i.e., a self-help book.The treatment is comprised of 12 modules or chapters, which entail information about stress management techniques including behavioral activation and exposure. The participant that chooses online CBT is guided by a therapist who provides feedback on homework assignments through written asynchronous text messages; the patient who chooses bibliotherapy is guided by a therapist in typically 2 to 5 face-to-face sessions at a primary care clinic.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2025-07-07
Completion
2025-07-07

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04820283 on ClinicalTrials.gov