NCT Number: NCT04522713
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Karolinska Institutet, Stockholm, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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?"
Time frame: Post-course assessment (within 45 days after the course)
Clinical interview
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Karolinska Institutet
Other
Single-Arm Feasibility Study of a Transdiagnostic Course for Common Mental Health Problems in Primary Care
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