Clinical trial NCT04820283: Early Interventions for Primary Care Patients With Stress-related Ill-health: a Non-inferiority RCT
Official title: Early Interventions for Primary Care Patients With Stress-related Ill-health: a Randomized Controlled Non-inferiority Trial of a Collaborative Care Intervention vs. Cognitive Behavior Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2021-03-29
Enrollment: 172
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Secondary outcomes:
measure: Shirom-Melamed Burnout Questionnaire (SMBQ)
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
measure: Brunnsviken Brief Quality of Life Index (BBQ)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up
measure: EuroQol 5D (EQ5D)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up
measure: Trimbos and Institute of Medical Technology Assessment of Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up
measure: Sick leave
timeFrame: 1 year from baseline
Other outcomes:
measure: Credibility Scale (C-Scale)
timeFrame: Week 3
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: week 12 (Post-treatment)
measure: Recovery Experience Questionnaire Short (REQ-S): putative mediator
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment)
measure: Negative Events Questionnaire (NEQ-20)
timeFrame: Week 12 (post-treatment)
measure: Adjustment Disorder New Module-8 (ADNM-8)
timeFrame: Baseline
Locations:
city: Gustavsberg
country: Sweden
facility: Gustavsbergs Primary Care Center
state: Stockholm
Study officials:
References: