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Enrolling by invitation NCT07259109

Psychopathology in Adolescence

— Observational Anxiety Disorders Depressive Disorder Obsessive-Compulsive Disorder Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Anxiety Disorders, Depressive Disorder, Obsessive-Compulsive Disorder, Mental Health. Basic parameters: 12 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Psychotherapy and Psychopathology in Adolescence: an Observational Study

Overview

This observational study aims to evaluate the effectiveness of two different psychotherapy approaches-Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST)-in treating adolescents with psychological disorders. The study will follow adolescents aged 12 to 20 who are receiving psychotherapy as part of their routine clinical care at the IRCCS Centro Neurolesi "Bonino-Pulejo" in Messina, Italy. Participants will not be randomly assigned to a treatment; instead, their natural clinical path will be observed. Data will be collected through standardized psychological assessments at the beginning, during, and after the therapy, as well as at follow-ups at 3 and 9 months. The goal is to understand which therapeutic model is more effective in improving symptoms, quality of life, and self-esteem in adolescents, and how individual and family factors influence treatment outcomes.

Detailed description

This is a 5-year observational study evaluating the effectiveness and clinical characteristics of two psychotherapy approaches-Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST)-in adolescents with psychiatric disorders. Patients aged 12 to 20 receiving care at the IRCCS Centro Neurolesi "Bonino-Pulejo" will be followed according to standard clinical practice, without random assignment. Psychopathological symptoms, self-esteem, and quality of life will be assessed at multiple time points (baseline, mid-treatment, end of treatment, and 3- and 9-month follow-ups) using standardized psychological tools. A propensity score matching method will be applied to reduce selection bias between treatment groups. The study also aims to identify predictors of treatment response and explore the influence of clinical and family-related factors on therapeutic outcomes. Data will be analyzed using both intra-group and inter-group statistical comparisons.

Primary outcome measures

  • Child Behavior Checklist (CBCL) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • SAFA General Screening Scales [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • Personality Inventory for DSM (PID) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • Toronto Alexithymia Scale (TAS-20) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • Barratt Impulsiveness Scale (BIS-11) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
Secondary outcome measures (4)
  • Rosenberg Self-Esteem Scale (RSES) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • Wechsler Intelligence Scale for Children (WISC-IV) / Raven's Progressive Matrices [Time frame: Baseline]
  • Depression Anxiety Stress Scales - Short Version (DASS-21) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]
  • WHO Quality of Life Questionnaire - Brief (WHOQOL-BREF) [Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12]

Eligibility criteria

Inclusion criteria

  • Adolescents aged 12 to 20 years
  • Clinical diagnosis of a psychiatric disorder according to DSM-5 criteria
  • Intelligence Quotient (IQ) ≥ 80
  • Written informed consent signed by participant and/or legal guardian

Exclusion criteria

  • Comorbid diagnosis of major neuropsychiatric disorders (e.g., autism spectrum disorder, schizophrenia)
  • Intelligence Quotient (IQ) ≤ 79
  • Lack of signed informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Centro Neurolesi Bonino Pulejo — Messina

Identifiers

NCT: NCT07259109 · PSY25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗