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

Stress Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04820283
• Other study ID #: Early interventions for stress
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 172
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Gustavsbergs Primary Care Center	Gustavsberg	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Credibility Scale (C-Scale)	Week 3 point estimate of treatment credibility rating (scale range 0-50, higher score means higher credibility)	Week 3
Other	Client Satisfaction Questionnaire-8 (CSQ-8)	Post-treatment point estimate of satisfaction with treatment (scale range 8-32, higher score means higher satisfaction with treatment)	week 12 (Post-treatment)
Other	Recovery Experience Questionnaire Short (REQ-S): putative mediator	Change in REQ-S at post-treatment compared to baseline (scale range 0-28, higher score means more recovery)	Baseline, weeks 3, 6, 9, 12 (post-treatment)
Other	Negative Events Questionnaire (NEQ-20)	Post-treatment estimate of potential negative events during treatment (scale range 0-80 where higher score means more negative events)	Week 12 (post-treatment)
Other	Adjustment Disorder New Module-8 (ADNM-8)	Point estimate at baseline for screening purposes (scale range 8-32 where higher score means more symptoms)	Baseline
Primary	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	Shirom-Melamed Burnout Questionnaire (SMBQ)	Change in SMBQ at post-treatment and follow-up compared to baseline (scale range 1-7, higher score means more symptoms)	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Secondary	Insomnia Severity Index (ISI)	Change in ISI at post-treatment and follow-up compared to baseline (scale range 0-28, higher score means more symptoms)	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	Change in GAD-7 at post-treatment and follow-up compared to baseline (scale range 0-21, higher score means more symptoms)	Baseline, week 12 (post-treatment), 1-year follow-up
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Change in PHQ-9 at post-treatment and follow-up compared to baseline (scale range 0-27, higher score means more symptoms)	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Secondary	Brunnsviken Brief Quality of Life Index (BBQ)	Change in BBQ at post-treatment and follow-up compared to baseline (scale range 0-96, higher score means higher quality of life)	Baseline, week 12 (post-treatment), 1-year follow-up
Secondary	EuroQol 5D (EQ5D)	Change in EQ5D at post-treatment and follow-up compared to baseline (the answers will be converted to utility score of health states ranging from 0 to 1 where 0 represents death and 1 full health)	Baseline, week 12 (post-treatment), 1-year follow-up
Secondary	Trimbos and Institute of Medical Technology Assessment of Cost Questionnaire for Psychiatry (TIC-P)	The TIC-P enables estimation of costs by collecting information about participant resource utilization and costs related to production loss. Change in costs will be analyzed at post-treatment and follow-up compared to baseline.	Baseline, week 12 (post-treatment), 1-year follow-up
Secondary	Sick leave	Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full day equivalents.	1 year from baseline