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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