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Table 1 World Health Organization Trial Registration Data Set

From: Study protocol for a randomized controlled trial of a group cognitive-behavioral course for depressed adolescents

Data Category Information
Primary registry and trial identifying number ISRCTN registry ISRCTN19700389
Date of registration in primary registry 6 October 2015
Secondary identifying numbers Protocol/serial number: 238081
Source(s) of monetary or material support The Norwegian Research Council
Primary sponsor The Norwegian Research Council
Secondary sponsor(s) The Norwegian Center for Child Behavioral Development
Contact for public queries Görel Bringedal g.e.bringedal@atferdssenteret.no
Contact for scientific queries Thormod Idsoe thormod.idsoe@atferdssenteret.no
Public title Effectiveness study of a CBT based adolescent coping with depression course
Scientific title Effectiveness study of a CBT based adolescent coping with depression course to prevent dropout in upper secondary school
Countries of recruitment Norway
Health condition(s) or problem(s) studied Mild/moderate depression among adolescents
Intervention(s) Active comparator: CBT-based group intervention, 8 consecutive weekly sessions of 120 min, two follow-up sessions conducted about 3 and 6 weeks after the last session, lasting approximately 90 min
  Placebo comparator: Usual care
Key inclusion and exclusion criteria Cluster-randomized design where the course-leaders are recruited from the School Health Service, Public Health Nurses, the Educational and Psychological Counselling Services (PPT). They are then taught how to recruit a group of 1st or second year students from Upper Secondary School (Videregående skole). A complete assessment of possible participants (adolescents) has to be made by the course instructors before acceptance into the study.
  Inclusion criteria for adolescents:
  1. First or second year of upper secondary school (about 16–17 years old)
  2. Who have subclinical depression or mild to moderate major depressive disorder (MDD), according to the criteria of the DSM
  3. Normal intellectual functioning
  4. Normal reading abilities, and that was evaluated through the interview.
  Exclusion criteria for adolescents:
  1. Bipolar disorder
  2. Psychosis
  3. Substance-use
  4. ADHD or ADD
  5. Brain damage
  6. Danger of suicide
  7. Adolescents who are easily agitated
  8. Adolescents who lack the ability to function in a group
Study type Single-centre cluster-randomized effectiveness trial with active control. Primary study design
  Interventional, Secondary study design
  Cluster randomised trial
Date of first enrolment 01/11/2015
Target sample size 35 clusters with 8–12 adolescents within each cluster
Recruitment status Recruiting
Primary outcome(s) 1. Center for Epidemiological Studies Depression Scale, CES-D for adolescents, at Pre-test, T1, T2, T3, T4
  2. Dysfunctional Attitudes Scale (DAS) (short version) at Pre-test, T2, T3, T4
  3. Automatic Thoughts Questionnaire (ATQ) (short version) at Pre-test, T2, T3, T4
  4. Ruminative Response Scale (RRS) (short version) at Pre-test, T2, T3, T4
  5. Emotion regulation at Pre-test, T2, T3, T4
  6. Dropout (from school and official registries) at T1, T2, T3, T4
  7. Grades at T1, T2, T3, T4
Key secondary outcomes 1. Intentions to quit school at Pre-test, T2, T3, T4
  2. Social and Cognitive Competence at Pre-test, T2, T3, T4
  3. Life events at Pre-test, T2, T3, T4