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

NCT ID: NCT04820283

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2025-07-07

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.

Detailed Description

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. In this study collaborative care is conducted by a nurse who provides the patient with self-management support. This intervention has been implemented at Gustavsbergs primary care clinic in Stockholm as a means to increase accessibility and quality of care for the large group of patients with stress-related ill-health. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group.

Our research group has developed and tested a therapist-guided self-help CBT (SH-CBT) that can be delivered online or as a self-help book with support by a clinician for stress-related ill health, which has been shown to be effective and also potentially very suitable for the primary care context. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and SH-CBT - can be effective as early interventions for primary care patients with stress-related ill-health.

Main research question: Is a brief collaborative care intervention provided by a nurse at least as effective as SH-CBT delivered by a psychologist for primary care patients with mild to moderate symptoms of stress?

Note: In may 2022, the research group made revisions to the study procedures in terms of administration format of CBT and inclusion criteria. These specific changes were made: (1) Participants randomized to SH-CBT are allowed to choose if they want to receive the treatment as therapist-guided online CBT or as therapist-guided bibliotherapy CBT. Participants are exposed to the same treatment content, but in the former case the material is presented on a secure website with asynchronous written therapist support and in the latter case the content is provided through a self-help book and the participant has 2-5 face-to-face appointments with the therapist; (2) It is no longer required that participants has adjustment disorder, instead participants have to have (a) a score on the Perceived Stress Scale-10 of 20 or higher, (b) stress-related ill-health as their principal problem, and (c) a duration of their problems of at least 1 month; (3) The sick-leave criterion is changed so that participants to be included are allowed to have been on full time sick-leave for maximum 2 months (instead of 50% for maximum 1 month).

The revisions described above were made in order to better operationalize the patient population "patients with mild to moderate stress-related ill-health" and to increase the recruitment of participants to the study. When the revisions were implemented approximately 20 participants had been included in the study. The revisions were approved by the Swedish Ethical Review Authority (ID 2022-00990-02).

Note 2: In the autumn of 2023, a new power calculation was conducted where full use of the 5 assessment points between baseline and post-treatment (12 weeks) was taken into account. This new power calculation, based in linear mixed models analysis for longitudinal data, showed that in order to have 80% power to demonstrate non-inferiority (non-inferiority margin d=0.3; one-sided 95% confidence interval) given a true effect difference of 0, approximately 170 participants (85 per treatment arm) will be needed.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Care manager intervention (nurse)

Group Type: EXPERIMENTAL

Care manager intervention (nurse)

Intervention Type: 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.

Internet-based CBT

Group Type: ACTIVE_COMPARATOR

CBT

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Ongoing other psychological treatment for stress-related problems

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erik Hedman

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gustavsbergs Primary Care Center

Gustavsberg, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

Early interventions for stress

Identifier Type: -

Identifier Source: org_study_id