Treatment and prevention of depression symptoms in mental health services Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomized in the following three treatment arms (1:1:1):
1. Stepped care model: guided self-help (GSH, average number of sessions 3) followed by face-to-face cognitive behaviora
=10 p on the PHQ-9) and by research location.
The duration of treatments in the study arms are as follows:
1. Sequential treatment of guided self-help and face-to-face CBT (stepped care): approximate
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 (guided self-help, iCBT or CBT intervention) for depression in the first assessment 3. PHQ-9 =5
Exclusion criteria
Exclusion criteria: 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 |
|---|---|
| Within-individual change in depression symptoms measured by the PHQ-9. The PHQ-9 is administered weekly from the beginning of the intervention for 16 weeks and at follow-up time points (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 participant self-report at T0, T3, T4, T5, and all optional follow-ups 2. Employment status is measured using participant self-report at T0, T3, T4, T5, and all optional follow-ups 3. Income in the previous year is measured using participant self-report at T0, T5, and all optional follow-ups 4. Alcohol use is measured using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C/AUDIT) at T0, T3, T4, T5, and all optional follow-ups 5. Healthcare visits over the previous 12 months are measured using participant self-report at T0, T5, and all optional follow-ups 6. Severity of anxiety symptoms is measured using the Generalized Anxiety Disorder-7 (GAD-7) at T2, T3, T4, T5, and all optional follow-ups and weekly from the beginning of the intervention for 16 weeks 7. Subjective work ability is measured using participant self-report at T0, T2, T3, T4, T5, and all optional follow-ups 8. Perceived social support is measured using the Perceived Social Support Scale-Revised (PSSS-R) at T0, T3, T4, T5, and all optional follow-ups 9. Functional impairment is measured using the Work and Social Adjustment Scale (WSAS) at T0, T3, T4, T5, and all optional follow-ups 10. Quality of life is measured using the EQ-5D-5L and Euro Health Interview Survey (Euro-HIS) at T0, T3, T4, T5, and all optional follow-ups 11. The number of intervention sessions attended is measured using participant records at T2 12. Patient experience of the intervention is measured using participant self-report at T2 13. Direct and indirect healthcare, social care, employment, and societal costs are measured using Finnish national registries at T0, T3, T4, T5, and all optional follow-ups These outcome measures, combined with data from Finnish national registries, will provide a comprehensive overview of the effectiveness and cost-efficiency of the treatments being studied. | — |
Countries
Finland
Contacts
Public ContactKatariina Mattila
Outcome results
None listed