Table 1 WHO Trial Registration Data Set
Data category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov NCT02667366 |
Date of registration in primary register | 3 December 2015 |
Sources of monetary or material support | Gottfried and Julia Bangerter-Rhyner-Foundation (Bangerter-Stiftung) and Swiss Academy of Medical Sciences (Schweizerische Akademie der Medizinischen Wissenschaften, SAMW) |
Primary sponsor(s) | Prof. Birgit Watzke, University of Zurich |
Contact for public queries | M.Sc. Elisa Haller Department of Clinical Psychology and Psychotherapy Research Binzmühlestrasse 14/16, CH-8050 Zürich Switzerland e.haller@psychologie.uzh.ch |
Contact for scientific queries | Prof. Dr. Birgit Watzke Department of Clinical Psychology and Psychotherapy Research Binzmühlestrasse 14/16, CH-8050 Zürich Switzerland b.watzke@psychologie.uzh.ch |
Public title | Telephone-Intervention/Information for Depression (TIDe) |
Scientific title | Effectiveness and cost-effectiveness of a telephone-based cognitive-behavioural therapy in primary care for mild to moderate depression |
Countries of recruitment | Switzerland |
Health condition(s) or problem(s) studied | Mild to moderate depression |
Intervention(s) | Telephone-delivered short-term cognitive-behavioural therapy |
Key inclusion and exclusion criteria | Inclusion criteria: Age ≥ 18 years, mild to moderate depression according to ICD-10, PHQ-9 > 5 and ≤15, able to fill in questionnaires, German language Exclusion criteria: suicidality or suicidal tendency, currently or in last 3 months in psychotherapeutic treatment, chronic depression or dysthymia, severe depression, psychopharmacological medication that is not stable for 3 months prior to enrolment. |
Study type | Randomised-controlled superiority trial |
Date of first enrolment | January 2016 |
Target sample size | 216 |
Recruitment status | Recruiting |
Primary outcome(s) | Symptom severity at t2 (PHQ-9) |
Key secondary outcomes | Symptom severity at t1 (PHQ-9), Response defined as 50% reduction from t0 to t1,remission defined as <5 points in the PHQ-9 at t2 and t1, relapse defined as ≥5 points in the PHQ at t2 following remission at t1, cost-effectiveness |