Background
Study rationale
Aim
Methods/Design
Design
Participants
Recruitment
Eligibility criteria
Inclusion criteria
Exclusion criteria
Randomization and blinding
Sample size calculation
Study conditions
The wait-list control group
Video-based transdiagnostic REBT prevention program
Session number | Content |
---|---|
1 | Psychoeducation regarding internalizing problems |
2 | How to identify anxiety and depression. Relaxation |
3 | The ABC model of distress |
4 | Cognitive restructuring |
5 | Exposure and behavioral activation. Problem solving |
6 | Maintenance of therapeutic gains and relapse prevention |
Therapists
Data collection
Outcomes
Demographic data
Primary outcomes
Anxiety symptoms
Depressive symptoms
Secondary outcomes
Comorbid problems
Maladaptive cognitions
Quality of life
Treatment expectancies
Satisfaction with the intervention
Statistical methods
Monitoring study implementation
Ethics and dissemination
Data category | Information |
---|---|
Primary registry and trial identifying number | ClinicalTrials.gov NCT02756507 |
Date of registration in primary registry | 25 April 2015 |
Secondary identifying numbers | The Ethics Committee of Babeș-Bolyai University (Registration number: 33215/ 03.06.2016) |
Sources of monetary or material support | The Romanian Executive Unit for Financing Education Higher Research, Development and Innovation, Babeș-Bolyai University |
Primary sponsor | Babeș-Bolyai University |
Contact for public queries | Costina Ruxandra Păsărelu Department of Clinical Psychology and Psychotherapy Babeș-Bolyai University Romania Republicii St., No. 37 Postal code: 400015 E-mail: costina.pasarelu@ubbcluj.ro |
Contact for scientific queries | Prof. Anca Dobrean Babeș-Bolyai University Republicii St., No. 37 Postal code: 400015 E-mail: anca.dobrean@ubbcluj.ro |
Public title | Transdiagnostic REBT Prevention Program for Adolescents |
Scientific title | A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents |
Countries of recruitment | Romania |
Health condition(s) or problem(s) studied | Anxiety Depression Internalizing problems |
Intervention(s) | Experimental: video-based transdiagnostic REBT prevention program Control: waiting list |
Key inclusion and exclusion criteria | Inclusion criteria: Preadolescents and adolescents will have ages between 12 and 17 years old; Are attending middle school or high-school; Adolescents have sufficient understanding of the Romanian language in order to complete assessments at all time points and to participate in the prevention program; Their parents have sufficient understanding of the Romanian language in order to sign the informed consent; Parents will sign the informed consent and adolescents will provide informed assent. Exclusion criteria: Age below 12 or above 17 years; No signed informed consent from parents; Adolescents will score high on suicidal ideation according to (1 item on the Depression subscale from Beck Youth Inventories); Not Romanian-speaking in order to understand the content of the prevention program and to complete the assessments. |
Study type | Randomized controlled trial |
Date of first enrollment | June 2016 |
Target sample size | 338 |
Recruitment status | Recruiting |
Primary outcome(s) | Anxiety symptoms at T2, T3, T4; the Multidimensional Anxiety Scale for Children Depressive symptoms at T2, T3, T4; the Beck Youth Inventories™ -Second Edition for Children and Adolescents |
Key secondary outcome(s) | Maladaptive cognitions at T2, T3, T4; the Children’s Automatic Thoughts Scale – Negative/Positive Comorbid problems at T2, T3, T4; the Strengths and Difficulties Questionnaire Prosocial behaviors Quality of life at T2, T3, T4; the Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version – adolescent version Treatment expectancies at T2; the Credibility/ Expectancy Questionnaire Satisfaction with the intervention at T2; the Client Satisfaction Scale |