Anxiety Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomized to the following treatment arms (1:1) (performed using the randomization feature of the REDCap application):
1. Stepped care model: guided self-help (GSH, average numbe
Sponsors
Helsinki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Minimum age of 16 years 2. Suitable for step 1-2 treatments (GSH and/or CBT intervention) for anxiety in the first assessment 3. GAD-7 =10 p
Exclusion criteria
Exclusion criteria: General exclusion criteria for step 1-2 treatments (i.e. recommended stepping up): 1. Serious suicidal thoughts, plans or any self-harming act or suicidal attempt within the past 2 months 2. Ongoing other psychological treatment for depression and/or anxiety 3. Cognitive impairment 4. Inability to speak, read and write Finnish 5. Currently symptomatic psychotic illness or bipolar disorder 6. Drug or alcohol dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety symptoms measured by the GAD-7. The GAD-7 is administered weekly from the beginning of the intervention for 16 weeks and at follow-up timepoints (e.g. 4, 6, 8, and 12 months as well as 2, 5, 10, 15 and 20 years) to enable ITT (intention to treat) -analysis and modeling the symptom change in time. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychotropic medication use is measured using patient self-reports at baseline (T0), 4-month follow-up (T3), 6-month follow-up, 8-month (T4), 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 2. Employment status is measured using patient self-reports at baseline (T0), 4-month follow-up (T3), 6-month follow-up, 8-month (T4), 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 3. Income in the previous year is measured using patient self-reports at baseline (T0) and at 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 4. Alcohol use is measured using the Alcohol Use Disorders Identification Test-Concise (AUDIT-C/AUDIT) at baseline (T0), 4-month follow-up (T3), 6-month follow-up, 8-month (T4), 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 5. Healthcare visits over the previous 12 months are measured using patient self-reports at baseline (T0) and at, 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 6. Severity of depression symptoms is measured using the Patient Health Questionnaire (PHQ-9) weekly from the beginning of the intervention for 16 weeks, at post-treatment (T2), 4-month follow-up (T3), 6-month follow-up, 8-month (T4), 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 7. Subjective work ability is assessed using patient self-reports at baseline (T0), post-treatment (T2), 4-month follow-up (T3), 6-month follow-up, 8-month (T4), 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 8. Perceived social support is measured using the Perceived Social Support Scale-Revised (PSSSR) at baseline (T0), 4-month follow-up (T3), 6-month follow-up, 8-month (T4), 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). 9. Functional impairment is measured using the Work and Social Adjustment Scale (WSAS) at baseline (T0), 4-mo | — |
Countries
Finland
Contacts
Public ContactKatariina Mattila
Outcome results
None listed