Anxiety, Depression
Conditions
Keywords
Transdiagnostic, Primary care, Feasibility
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.
Interventions
BEHAVIORALBehavioral 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
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Psychological intervention, self-report outcomes
Intervention model description
Prospective single-group cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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 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. |
| 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? |
Countries
Sweden
Participant flow
Recruitment details
We intended to recruit 68 participants with clinically significant depression or anxiety, and up to 25 participants with subclinical depression and anxiety. When the target of 68 clinical participants had been met, the remaining scheduled eligibility interviews were completed for ethical reasons, which resulted in a final clinical sample size of 70. By that time, 21 subclinical participants had been enrolled, which resulted a total sample size of 91.
Pre-assignment details
All participants were enrolled in the course.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 91 |
| Total | 91 |
Baseline characteristics
| Characteristic | Large-group Transdiagnostic Course | — |
|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 12 | — |
| Employment Other | 10 Participants | — |
| Employment Retired | 3 Participants | — |
| Employment Student | 9 Participants | — |
| Employment Unemployed | 3 Participants | — |
| Employment Working full-time | 55 Participants | — |
| Employment Working part-time (< 90%) | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 91 participants | — |
| Sex: Female, Male Female | 63 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
| University education | 71 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 91 |
| other Total, other adverse events | 8 / 86 |
| serious Total, serious adverse events | 0 / 91 |
Outcome results
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.
Time frame: Post-course assessment (immediately after the course, completed within 45 days)
Population: The trial included 91 participants: 70 clinical, and 21 subclinical. Of these, 86 (66 + 20) completed the CSQ-8 at the post-course assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Large-group Transdiagnostic Course | Overall Satisfaction With Treatment | Pooled sample (primary) | 22 score on a scale | Standard Deviation 4 |
| Large-group Transdiagnostic Course | Overall Satisfaction With Treatment | Clinical subsample | 21 score on a scale | Standard Deviation 4 |
| Large-group Transdiagnostic Course | Overall Satisfaction With Treatment | Subclinical subsample | 23 score on a scale | Standard Deviation 3 |
| Large-group Transdiagnostic Course | Overall Satisfaction With Treatment | Participants without previous experience of psychological treatment | 23 score on a scale | Standard Deviation 4 |
| Large-group Transdiagnostic Course | Overall Satisfaction With Treatment | Participants with previous experience of psychological treatment | 21 score on a scale | Standard Deviation 4 |
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
Time frame: From week 1 to week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Large-group Transdiagnostic Course | Adherence Operationalized as the Average Number of Attended Lectures | 5.0 lectures attended | Standard Deviation 1.6 |
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.
Time frame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Population: 70 clinical, 21 subclinical
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Large-group Transdiagnostic Course | Change in Mean Disability From Pre- to Post-Course Assessment | Clinical subsample | -4.1 units on a scale |
| Large-group Transdiagnostic Course | Change in Mean Disability From Pre- to Post-Course Assessment | Subclinical subsample | 0.4 units on a scale |
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.
Time frame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Population: 70 clinical, 21 subclinical
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Large-group Transdiagnostic Course | Change in Mean General Anxiety From Pre- to Post-Course Assessment | Clinical subsample | -3.8 units on a scale |
| Large-group Transdiagnostic Course | Change in Mean General Anxiety From Pre- to Post-Course Assessment | Subclinical subsample | -1.2 units on a scale |
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.
Time frame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Population: 70 clinical, 21 subclinical
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Large-group Transdiagnostic Course | Change in Mean Perceived Stress From Pre- to Post-Course Assessment | Subclinical subsample | -1.5 units on a scale |
| Large-group Transdiagnostic Course | Change in Mean Perceived Stress From Pre- to Post-Course Assessment | Clinical subsample | -3.3 units on a scale |
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.
Time frame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Population: 70 clinical, 21 subclinical
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Large-group Transdiagnostic Course | Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment | Clinical subsample | -4.8 units on a scale |
| Large-group Transdiagnostic Course | Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment | Subclinical subsample | -1.5 units on a scale |
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?
Time frame: From week 1 to week 6
Population: 86/91 participants completed the post-course assessment at week 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Large-group Transdiagnostic Course | Number of Adverse Events | 9 adverse events reported |
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.
Time frame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large-group Transdiagnostic Course | Number of Participants With Clinically Significant Improvement in General Anxiety | 27 Participants |
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.
Time frame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large-group Transdiagnostic Course | Number of Participants With Clinically Significant Improvement in Symptoms of Depression | 22 Participants |
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).
Time frame: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Population: 86/91 participants completed the post-course assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Pre-course: At least one unhealthy lifestyle behavior | 40 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Post-course: At least one unhealthy lifestyle behavior | 36 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Pre-course: Daily smoking | 2 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Post-course: Daily smoking | 2 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Pre-course: Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week | 17 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Post-course: Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week | 15 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Pre-course: Insufficient physical activity, less than 150 minutes/week | 22 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Post-course: Insufficient physical activity, less than 150 minutes/week | 22 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Pre-course: Notably unhealthy dietary habits (diet index 0-4) | 11 Participants |
| Large-group Transdiagnostic Course | Number of Participants With Problematic Lifestyle Behaviors | Post-course: Notably unhealthy dietary habits (diet index 0-4) | 15 Participants |
Secondary
Percentage of Patients in Need of Additional Clinical Intervention
Clinical interview
Time frame: Post-course assessment (within 45 days after the course)
Population: 81/91 completed the post-course interview
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large-group Transdiagnostic Course | Percentage of Patients in Need of Additional Clinical Intervention | 44 Participants |