| Primary | Overall Satisfaction With Treatment | 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. | The trial included 91 participants: 70 clinical, and 21 subclinical. Of these, 86 (66 + 20) completed the CSQ-8 at the post-course assessment. | Posted | | Mean | Standard Deviation | score on a scale | | Post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
| | | Title | Denominators | Categories |
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| Pooled sample (primary) | | | | Clinical subsample | |
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| Secondary | Adherence Operationalized as the Average Number of Attended Lectures | Attendance, i.e., participation in the course, registered once each week, after each course date, by a clinician during the course period | | Posted | | Mean | Standard Deviation | lectures attended | | From week 1 to week 6 | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Number of Participants With Clinically Significant Improvement in Symptoms of Depression | 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. | For depression symptoms, only those who had a score of at least 10 on the PHQ-9 at baseline could potentially be classified as clinically significant improved. This was done to ensure that the clinical cut-off was not too liberal and also that all participants scored in the clinical range at baseline. | Posted | | Count of Participants | | Participants | | Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Number of Participants With Clinically Significant Improvement in General Anxiety | 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. | For general anxiety, only those who had a score of at least 8 on the GAD-7 at baseline could potentially be classified as clinically significant improved. This was done to ensure that the clinical cut-off was not too liberal and also that all participants scored in the clinical range at baseline. | Posted | | Count of Participants | | Participants | | Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Number of Participants With Problematic Lifestyle Behaviors | 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). | 86/91 participants completed the post-course assessment | Posted | | Count of Participants | | Participants | | Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Number of Adverse Events | Weekly question: "Since the last assessment, have you experienced any adverse event, side effect, or unwanted effect of your participation in this study?" | 86/91 participants completed the post-course assessment at week 6 | Posted | | Number | | adverse events reported | | From week 1 to week 6 | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Percentage of Patients in Need of Additional Clinical Intervention | | 81/91 completed the post-course interview | Posted | | Count of Participants | | Participants | | Post-course assessment (within 45 days after the course) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment | Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression). Efficacy outcomes based on linear mixed models. | 70 clinical, 21 subclinical | Posted | | Mean | 95% Confidence Interval | units on a scale | | Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Change in Mean General Anxiety From Pre- to Post-Course Assessment | GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety). Efficacy outcomes based on linear mixed models. | 70 clinical, 21 subclinical | Posted | | Mean | 95% Confidence Interval | units on a scale | | Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Change in Mean Perceived Stress From Pre- to Post-Course Assessment | 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. | 70 clinical, 21 subclinical | Posted | | Mean | 95% Confidence Interval | units on a scale | | Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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| Secondary | Change in Mean Disability From Pre- to Post-Course Assessment | 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. | 70 clinical, 21 subclinical | Posted | | Mean | 95% Confidence Interval | units on a scale | | Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days) | | | | ID | Title | Description |
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| OG000 | Large-group Transdiagnostic Course | 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material: Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms |
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