ISRCTN14296278
Active, not recruiting
未知
Effectiveness and cost-effectiveness of stepped care guided self-help followed by face-to-face cognitive behavioral therapy versus standalone internet-delivered or face-to-face cognitive behavioral therapy for depression: a randomized controlled non-inferiority trial of the finnish first-line therapies –initiative
Helsinki University Hospital0 sites948 target enrollmentSeptember 18, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Treatment and prevention of depression symptoms in mental health services
- Sponsor
- Helsinki University Hospital
- Enrollment
- 948
- Primary Endpoint
- 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.
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.Minimum age of 16 years2.Suitable for step 1-2 treatments (guided self-help, iCBT or CBT intervention) for depression in the first assessment3.PHQ-9 =5
Exclusion Criteria
- •Serious suicidal thoughts, plans or any self-harming act or suicidal attempt within the past 2 months
- •Ongoing other psychological treatment for depression and/or anxiety
- •Cognitive impairment
- •Inability to speak, read and write Finnish
- •Currently symptomatic psychotic illness or bipolar disorder
- •Drug or alcohol dependence
Outcomes
Primary Outcomes
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.
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