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

NCT04820283 | Completed

• 1 other identifier: Early interventions for stress
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale (PSS-10)

  Change in PSS at post-treatment and follow-up compared to baseline (scale range 0-40, higher score means more symptoms)

  Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up

Secondary Outcomes (8)

• Shirom-Melamed Burnout Questionnaire (SMBQ)

  Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up

• Insomnia Severity Index (ISI)

  Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, week 12 (post-treatment), 1-year follow-up

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up

• Brunnsviken Brief Quality of Life Index (BBQ)

  Baseline, week 12 (post-treatment), 1-year follow-up

Other Outcomes (5)

• Credibility Scale (C-Scale)

  Week 3

• Client Satisfaction Questionnaire-8 (CSQ-8)

  week 12 (Post-treatment)

• Recovery Experience Questionnaire Short (REQ-S): putative mediator

  Baseline, weeks 3, 6, 9, 12 (post-treatment)

Study Arms (2)

Care manager intervention (nurse)

EXPERIMENTAL

Behavioral: Care manager intervention (nurse)

Internet-based CBT

ACTIVE COMPARATOR

Behavioral: CBT

Interventions

Care manager intervention (nurse) BEHAVIORAL

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.

Care manager intervention (nurse)

CBT BEHAVIORAL

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.

Internet-based CBT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 16 years of age
• A score of 20 or higher on the Perceived Stress Scale-10
• Stress-related ill-health is the principal problem
• Duration of problems for at least 1 month
• Have symptoms in the mild to moderate range
• Be able to read and write in Swedish
• Have access to a computer with Internet connection
• If the participant is on sick leave then the sick leave period should have a maximum duration of 2 months (full time sick-leave for 2 months is thus allowed)

You may not qualify if:

• Ongoing other psychological treatment for stress-related problems

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Gustavsbergs Primary Care Center

Gustavsberg, Stockholm County, 134 40, Sweden

Location

MeSH Terms

Interventions

Nurses

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled non-inferiority trial with two arms. A non-inferiority margin of Cohen's d 0.3 on the primary outcome Perceived Stress Scale at post-treatment (change from baseline to 12 weeks) will be used. For test of non-inferiority on the primary outcome, a one-sided 95% confidence interval (CI) will be used. If the two-sided 95% CI (exploratory analyses) does not include 0 this will be interpreted as indicating superiority of the corresponding treatment.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: April 29, 2021
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

SE (1)