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Table 1 WHO Trial Registration Data Set

From: Effectiveness and cost-effectiveness of telephone-based cognitive-behavioural therapy in primary care: study protocol of TIDe – telephone intervention for depression

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