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Psykopatologi i ungdomsårene

12. november 2026 opdateret af: IRCCS Centro Neurolesi Bonino Pulejo

Psykoterapi og psykopatologi i ungdomsårene: en observationsundersøgelse

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

192

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 20 år (Barn, Voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child Behavior Checklist (CBCL)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rosenberg Self-Esteem Scale (RSES)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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
Tidsramme: Baseline

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)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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)
Tidsramme: Baseline, Month 3, Month 6, Month 9, and Month 12

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Session Rating Scale (SRS)
Tidsramme: Each session over 10 sessions (approximately 10 weeks)

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)
Tidsramme: Each session over 10 sessions (approximately 10 weeks)

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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2025

Primær færdiggørelse (Anslået)

1. december 2030

Studieafslutning (Anslået)

1. marts 2031

Datoer for studieregistrering

Først indsendt

4. juli 2025

Først indsendt, der opfyldte QC-kriterier

21. november 2025

Først opslået (Faktiske)

2. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PSY25

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