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

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ClinicalTrials.gov Identifier: NCT04820283
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : May 10, 2021
Sponsor:
Collaborator:
Region Stockholm
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet

Study Description
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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 Internet-based CBT -can be effective as early interventions for primary care patients with stress-related ill-health.

Condition or disease Intervention/treatment Phase
Adjustment Disorder Behavioral: Care manager intervention (nurse) Behavioral: Internet-based CBT Not Applicable

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 (operationalized as ICD-11 adjustment disorder). 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 an Internet-based CBT (ICBT) 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 ICBT - 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 ICBT delivered by a psychologist for primary care patients with mild to moderate symptoms of stress (ICD-11 adjustment disorder)?

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 (12 weeks from baseline) will be used. If the 95% CI does not include 0 this will be interpreted as indicating superiority of the corresponding treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
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. Online Cognitive Behavior Therapy
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Care manager intervention (nurse) 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.
Active Comparator: Internet-based CBT Behavioral: Internet-based CBT
In this intervention, the participant receives treatment via an online treatment platform. The treatment is comprised of 12 modules, which entail information about stress management techniques including behavioral activation and exposure. The participant is guided by an online therapist who provides feedback on homework assignments.


Outcome Measures
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Primary Outcome Measures :
  1. Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up ]
    Change in PSS at post-treatment and follow-up compared to baseline (scale range 0-40, higher score means more symptoms)


Secondary Outcome Measures :
  1. Shirom-Melamed Burnout Questionnaire (SMBQ) [ Time Frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up ]
    Change in SMBQ at post-treatment and follow-up compared to baseline (scale range 1-7, higher score means more symptoms)

  2. Insomnia Severity Index (ISI) [ Time Frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up ]
    Change in ISI at post-treatment and follow-up compared to baseline (scale range 0-28, higher score means more symptoms)

  3. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, week 12 (post-treatment), 1-year follow-up ]
    Change in GAD-7 at post-treatment and follow-up compared to baseline (scale range 0-21, higher score means more symptoms)

  4. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up ]
    Change in PHQ-9 at post-treatment and follow-up compared to baseline (scale range 0-27, higher score means more symptoms)

  5. Brunnsviken Brief Quality of Life Index (BBQ) [ Time Frame: Baseline, week 12 (post-treatment), 1-year follow-up ]
    Change in BBQ at post-treatment and follow-up compared to baseline (scale range 0-96, higher score means higher quality of life)

  6. EuroQol 5D (EQ5D) [ Time Frame: Baseline, week 12 (post-treatment), 1-year follow-up ]
    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)

  7. Trimbos and Institute of Medical Technology Assessment of Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: Baseline, week 12 (post-treatment), 1-year follow-up ]
    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.

  8. Sick leave [ Time Frame: 1 year from baseline ]
    Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full day equivalents.


Other Outcome Measures:
  1. Credibility Scale (C-Scale) [ Time Frame: Week 3 ]
    Week 3 point estimate of treatment credibility rating (scale range 0-50, higher score means higher credibility)

  2. Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: week 12 (Post-treatment) ]
    Post-treatment point estimate of satisfaction with treatment (scale range 8-32, higher score means higher satisfaction with treatment)

  3. Recovery Experience Questionnaire Short (REQ-S): putative mediator [ Time Frame: Baseline, weeks 3, 6, 9, 12 (post-treatment) ]
    Change in REQ-S at post-treatment compared to baseline (scale range 0-28, higher score means more recovery)

  4. Negative Events Questionnaire (NEQ-20) [ Time Frame: Week 12 (post-treatment) ]
    Post-treatment estimate of potential negative events during treatment (scale range 0-80 where higher score means more negative events)

  5. Adjustment Disorder New Module-8 (ADNM-8) [ Time Frame: Baseline ]
    Point estimate at baseline for screening purposes (scale range 8-32 where higher score means more symptoms)


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 16 years of age
  • A principal diagnosis of adjustment disorder according to ICD-11
  • 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 1 month at maximum 50% of working time

Exclusion Criteria:

  • Ongoing other psychological treatment for stress-related problems
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820283


Contacts
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Contact: Elin Lindsäter, PhD +46 8 718 23 20 elin.lindsater@ki.se

Locations
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Sweden
Gustavsbergs Primary Care Center Recruiting
Gustavsberg, Stockholm, Sweden, 134 40
Contact: Elin Lindsäter, PhD       elin.lindsater@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Region Stockholm
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Erik Hedman, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04820283    
Other Study ID Numbers: Early interventions for stress
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adjustment Disorders
Trauma and Stressor Related Disorders
Mental Disorders