Psychopathology in Adolescence

Psychotherapy and Psychopathology in Adolescence: an Observational Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depressive Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Health; Adolescent - Emotional Problem; Psychoterapy

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.

• Study Type: Observational
• Enrollment (Estimated): 192

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Messina, Italy, Italy, 98100
      • IRCCS Centro Neurolesi Bonino Pulejo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adolescents aged 12 to 20 years with clinically diagnosed psychiatric disorders, referred to the Child and Adolescent Psychiatry Unit at IRCCS Centro Neurolesi "Bonino-Pulejo" in Messina, Italy. All participants will be receiving psychotherapy (CBT or BST) as part of standard clinical care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CBT Group; Participants receiving Cognitive Behavioral Therapy (CBT) as part of routine clinical care for adolescent psychopathology.
BST Group; Participants receiving Brief Strategic Therapy (BST) as part of routine clinical care for adolescent psychopathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior Checklist (CBCL)	The Child Behavior Checklist (CBCL) is a standardized parent-report questionnaire used to assess a wide range of emotional and behavioral problems in children. Higher scores indicate greater levels of emotional and behavioral difficulties.	Baseline, Month 3, Month 6, Month 9, and Month 12
SAFA General Screening Scales	The SAFA (Self Administrated Psychiatric Scales for Youths and Adolescents) is a comprehensive set of standardized self-report questionnaires used to assess emotional and psychiatric symptoms in children and adolescents aged 8 to 18 years. The full battery includes six scales: SAFA-A (Anxiety); SAFA-D (Depression); SAFA-O (Obsessive-Compulsive Symptoms); SAFA-S (Somatic Complaints); SAFA-P (Psychogenic Psychotic Symptoms); SAFA-F (Eating Disorders) Each scale produces a raw score, which is then converted into a standardized score. Total scores for each domain range approximately from 0 to 100, although precise ranges vary slightly by scale and age group. Higher scores reflect more severe emotional or psychological difficulties, i.e., a worse outcome.	Baseline, Month 3, Month 6, Month 9, and Month 12
Personality Inventory for DSM (PID)	The Personality Inventory for DSM-5 (PID-5) is a standardized self-report instrument developed to assess maladaptive personality traits aligned with the DSM-5 alternative model for personality disorders. It includes 220 items, rated on a 4-point Likert scale (0 = Very False or Often False; 3 = Very True or Often True), and provides scores on five broad domains: Negative Affectivity; Detachment; Antagonism; Disinhibition; Psychoticism Scores range from 0 to 660 (sum of all item scores), although domain and facet scores are typically reported separately. Higher scores reflect more severe or dysfunctional personality traits (i.e., a worse outcome).	Baseline, Month 3, Month 6, Month 9, and Month 12
Columbia-Suicide Severity Rating Scale (C-SSRS)	The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured clinical interview used to assess suicidal ideation and behavior. It includes subscales for suicidal thoughts, intent, plans, preparatory behavior, and actual suicide attempts. Each item is scored individually; for example: Suicidal ideation severity scale: 0 (no ideation) to 5 (active ideation with specific plan and intent),; Behavior subscale: binary indicators (yes/no) of actual, aborted, or interrupted attempts. Higher scores indicate greater severity of suicide risk and behavior (i.e., a worse outcome).	Baseline, Month 3, Month 6, Month 9, and Month 12
Toronto Alexithymia Scale (TAS-20)	The Toronto Alexithymia Scale (TAS-20) is a standardized self-report instrument designed to assess difficulties in identifying and describing emotions, and externally oriented thinking. It consists of 20 items, each rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree). Total scores range from 20 to 100, with higher scores indicating greater levels of alexithymia (i.e., worse emotional awareness).	Baseline, Month 3, Month 6, Month 9, and Month 12
Barratt Impulsiveness Scale (BIS-11)	The Barratt Impulsiveness Scale - Version 11 (BIS-11) is a widely used self-report questionnaire designed to assess impulsivity as a personality trait. It consists of 30 items, rated on a 4-point Likert scale from 1 (Rarely/Never) to 4 (Almost Always/Always). Total scores range from 30 to 120, with higher scores indicating greater impulsivity (i.e., a worse outcome).	Baseline, Month 3, Month 6, Month 9, and Month 12
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)	The DERS-SF (Difficulties in Emotion Regulation Scale - Short Form) is an 18-item self-report instrument that assesses difficulties in emotion regulation. Each item is scored on a 5-point Likert scale from 1 (Almost Never) to 5 (Almost Always). Total scores range from 18 to 90. Higher scores indicate greater difficulties in emotion regulation (i.e., a worse outcome).	Baseline, Month 3, Month 6, Month 9, and Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rosenberg Self-Esteem Scale (RSES)	The Rosenberg Self-Esteem Scale (RSES) is a widely used 10-item self-report questionnaire designed to measure global self-esteem in adolescents and adults. Each item is rated on a 4-point Likert scale (1 = Strongly Disagree to 4 = Strongly Agree), with both positively and negatively worded items. Total scores range from 10 to 40, with higher scores indicating higher self-esteem (i.e., a better outcome). Scores below 15 may indicate problematic low self-esteem.	Baseline, Month 3, Month 6, Month 9, and Month 12
Wechsler Intelligence Scale for Children (WISC-IV) / Raven's Progressive Matrices	Cognitive functioning is assessed at baseline using one or both of the following standardized instruments: The Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV), a widely used clinical tool for measuring verbal comprehension, perceptual reasoning, working memory, and processing speed. The Full Scale IQ (FSIQ) score ranges from 40 to 160, with higher scores indicating greater cognitive ability.; The Raven's Progressive Matrices is a non-verbal test of abstract reasoning and fluid intelligence. Standard scores range from 60 to 140, depending on the version and age norms. Higher scores indicate higher cognitive performance. Only participants with IQ ≥ 80 (as determined by one of the above instruments) are included in the study.	Baseline
Depression Anxiety Stress Scales - Short Version (DASS-21)	The DASS-21 (Depression Anxiety Stress Scales - Short Version) is a self-report questionnaire designed to measure negative emotional states across three domains: depression, anxiety, and stress. It consists of 21 items, with 7 items per subscale. Each item is rated on a 4-point Likert scale from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Subscale scores range from 0 to 21, and are commonly multiplied by 2 to obtain scores equivalent to the full DASS-42 (range: 0 to 42 per subscale). Higher scores indicate more severe symptoms (i.e., a worse outcome).)	Baseline, Month 3, Month 6, Month 9, and Month 12
WHO Quality of Life Questionnaire - Brief (WHOQOL-BREF)	The WHOQOL-BREF is a validated, 26-item self-report questionnaire developed by the World Health Organization to assess an individual's perceived quality of life. It includes four domains: Physical Health; Psychological Health; Social Relationships; Environment Each item is rated on a 5-point Likert scale, and domain scores are transformed to a scale from 0 to 100, where higher scores indicate better quality of life (i.e., a better outcome). The WHOQOL-BREF has been used across cultures and is suitable for both clinical and general populations.	Baseline, Month 3, Month 6, Month 9, and Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Session Rating Scale (SRS)	The Session Rating Scale (SRS) is a 4-item self-report measure used to assess the therapeutic alliance at the end of each therapy session. Each item is rated on a visual analog scale from 0 to 10, yielding a total score ranging from 0 to 40. The four dimensions assessed are: relationship, goals and topics, approach or method, and overall alliance. Higher scores indicate a stronger therapeutic alliance (i.e., a better outcome). Scores below 36 may indicate a need to address ruptures in the alliance.	Each session over 10 sessions (approximately 10 weeks)
Outcome Rating Scale (ORS)	The Outcome Rating Scale (ORS) is a 4-item self-report tool designed to measure a client's perception of change and progress in therapy. It evaluates functioning in four areas: individual (personal well-being), interpersonal (close relationships), social (work/school), and general well-being. Each item is scored from 0 to 10, resulting in a total score ranging from 0 to 40. Higher scores reflect greater perceived well-being and positive clinical change (i.e., a better outcome).	Each session over 10 sessions (approximately 10 weeks)

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: July 4, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Behavior; Personal Satisfaction; Anxiety Disorders; Depressive Disorder; Obsessive-Compulsive Disorder; Psychological Well-Being
• Other Study ID Numbers: PSY25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No