A Transdiagnostic Course for Common Mental Health Problems in Primary Care

Not Applicable

Completed

Conditions: Depression
Anxiety

Interventions: Behavioral: Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material

Registration Number: NCT04522713

Lead Sponsor: Karolinska Institutet

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 91

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Large-group transdiagnostic course	Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material	6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing

Primary Outcome Measures

Name	Time	Method
Overall Satisfaction With Treatment	Post-course assessment (immediately after the course, completed within 45 days)	Preregistered target: mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22. Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4. The original preregistered range of 7-28 was an erratum.

Secondary Outcome Measures

Name	Time	Method
Adherence Operationalized as the Average Number of Attended Lectures	From week 1 to week 6	Attendance, i.e., participation in the course, registered once each week, after each course date, by a clinician during the course period
Number of Participants With Clinically Significant Improvement in Symptoms of Depression	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)	Preregistered target: At least 1/3 patients reporting a clinically significant improvement in symptoms of depression. Dichotomous outcome based on the Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression). Clinically significant improvement implied a reduction of at least 6 points on the PHQ-9 in combination with a post-course score below 10.
Number of Participants With Clinically Significant Improvement in General Anxiety	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)	Preregistered target: At least 1/3 patients reporting a clinically significant improvement in general anxiety. Dichotomous outcome based on the GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety). Clinically significant improvement implied a reduction of at least 5 points on the GAD-7 in combination with a post-course score below 8.
Number of Participants With Problematic Lifestyle Behaviors	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)	Lifestyle behaviors were measured using the Lifestyle Behaviors Questionnaire (LBQ) which comprises 11 items that cover tobacco use, alcohol use, physical activity and diet. Dichotomous risky lifestyle behavior variables were derived from the LBQ in terms of: "At least one unhealthy lifestyle behavior", "Daily smoking", "Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week", "Insufficient physical activity, less than 150 minutes/week", and "Notably unhealthy dietary habits (diet index 0-4)". Risky lifestyle behavior was defined as daily smoking, binge drinking of 4/5 (women/men) drinks at one occasion more than once a month and/or more than 9/14 (women/men) standard glasses of alcohol weekly, insufficient physical activity (\<150 minutes/week) or significantly unhealthy diet habits (a score of 0-4 on a diet index in the questionnaire, ranging from 0-12).
Number of Adverse Events	From week 1 to week 6	Weekly question: "Since the last assessment, have you experienced any adverse event, side effect, or unwanted effect of your participation in this study?"
Percentage of Patients in Need of Additional Clinical Intervention	Post-course assessment (within 45 days after the course)	Clinical interview
Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)	Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression). Efficacy outcomes based on linear mixed models.
Change in Mean General Anxiety From Pre- to Post-Course Assessment	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)	GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety). Efficacy outcomes based on linear mixed models.
Change in Mean Perceived Stress From Pre- to Post-Course Assessment	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)	Perceived Stress Scale, 10-item version (PSS-10, theoretical range: 0-40, higher score indicates more perceived stress). Efficacy outcomes based on linear mixed models.
Change in Mean Disability From Pre- to Post-Course Assessment	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)	World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2, theoretical range: 0-100, higher score indicates more disability). Efficacy outcomes based on linear mixed models.