Clinical trial NCT04522713: A Transdiagnostic Course for Common Mental Health Problems in Primary Care
Official title: Single-Arm Feasibility Study of a Transdiagnostic Course for Common Mental Health Problems in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Transdiagnostic
Primary care
Feasibility
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2020-08-21
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-group cohort study
Primary purpose: TREATMENT

Brief summary: This study investigates the feasibility of a transdiagnostic course that is intended to work for a large variety of patient groups with clinically significant depression or anxiety in primary care. This is a prospective single-group study where 68 adults with clinically significant symptoms of depression or general anxiety, and up to 25 adults with subclinical symptoms, attend up to 6 weekly structured large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online.

Detailed description: Background:

Depression and the common anxiety disorders are highly prevalent and associated with disability and reduced quality of life. There is reason to believe that the majority of these patients are found in primary care. Official Swedish guidelines dictate that primary care clinics are responsible for treating mild to moderate cases, but access to treatment is limited. Transdiagnostic psychological interventions have been found to be efficacious for anxiety and mood disorders, and require a relatively rudimentary pre-treatment assessment. A large-group transdiagnostic course based on cognitive-behavioral principles may constitute an effective use of limited resources to improve access to treatment, and offer a sufficiently effective intervention, for most primary care patients with mild to moderate mental health problems.

Aim:

To investigate the feasibility and preliminary efficacy of a large-group transdiagnostic intervention for depression and clinically significant anxiety in Swedish primary care.

Design:

This is a prospective single-group feasibility study where 68 adults with clinically significant symptoms of depression or anxiety, and up to 25 adults with subclinical symptoms, are recruited from Liljeholmen primary care clinic, Stockholm, and offered 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online. The primary outcome is patient satisfaction. Secondary outcomes include within-group effects on psychiatric symptoms (response rates), adherence rates, need for additional treatment, and adverse events.

Eligibility criteria: Inclusion Criteria:

* At least 8 points on the GAD-7 or 10 points on the PHQ-9 (N=68; up to 25 subclinical participants may also take part in the study)
* At least 18 years old

Exclusion Criteria:

* At least one severe mental health problem such as suicidal ideation, a bipolar disorder, or psychosis
* Non-stable antidepressant medication (dosage changed during the past 6 weeks)
* Planned absence for 2 weeks or more of the intended treatment period

Primary outcomes:
measure: Overall Satisfaction With Treatment
timeFrame: Post-course assessment (immediately after the course, completed within 45 days)
Secondary outcomes:
measure: Adherence Operationalized as the Average Number of Attended Lectures
timeFrame: From week 1 to week 6
measure: Number of Participants With Clinically Significant Improvement in Symptoms of Depression
timeFrame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
measure: Number of Participants With Clinically Significant Improvement in General Anxiety
timeFrame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
measure: Number of Participants With Problematic Lifestyle Behaviors
timeFrame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
measure: Number of Adverse Events
timeFrame: From week 1 to week 6
measure: Percentage of Patients in Need of Additional Clinical Intervention
timeFrame: Post-course assessment (within 45 days after the course)
measure: Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment
timeFrame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
measure: Change in Mean General Anxiety From Pre- to Post-Course Assessment
timeFrame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
measure: Change in Mean Perceived Stress From Pre- to Post-Course Assessment
timeFrame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
measure: Change in Mean Disability From Pre- to Post-Course Assessment
timeFrame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Liljeholmen primary care clinic
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erland Axelsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: