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Impact of waiting time on the effectiveness and cost-effectiveness of stepped care guided self-help followed by face-to-face cognitive behavioral therapy versus standalone face-to-face cognitive behavioral therapy for depression

Impact of waiting time on the effectiveness and cost-effectiveness of stepped care guided self-help followed by face-to-face cognitive behavioral therapy versus standalone face-to-face cognitive behavioral therapy for depression: a randomized controlled trial of the Finnish firstline therapies initiative

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63914711
Enrollment
115
Registered
2024-10-08
Start date
2024-09-16
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment and prevention of depression symptoms in mental health services Mental and Behavioural Disorders

Interventions

Participants will be randomized in the following treatment arms (1:1) (performed using the randomization feature of the REDCap application): 1. Stepped care model: guided self-help (GSH, average numb

Sponsors

Helsinki University Hospital
Lead Sponsor

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 depression in the first assessment 3. PHQ-9 =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 depression 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

MeasureTime frame
Depression symptoms measured using the Patient Health Questionnaire (PHQ-9) 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

MeasureTime 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 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 workability is measured 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-month follow-up

Countries

Finland

Contacts

Public ContactKatariina Mattila
katariina.m.mattila@hus.fi+358 9 4711

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026