Anxiety DisordersNCT07259109
Psychopathology in Adolescence
An observational study of Anxiety Disorders and Depressive Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder, Obsessive-Compulsive Disorder
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Comorbid diagnosis of major neuropsychiatric disorders (e.g., autism spectrum disorder, schizophrenia)
- Intelligence Quotient (IQ) ≤ 79
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Disorders, Depressive Disorder, Obsessive-Compulsive Disorder, Mental Health, Adolescent - Emotional Problem, Psychoterapy
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Obsessive-Compulsive Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, Month 3, Month 6, Month 9, and Month 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).)
Measured: 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.
Measured: Baseline, Month 3, Month 6, Month 9, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Apr 2025
- Primary completionDec 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259109
- Sponsor's protocol ID
- PSY25
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy and Psychopathology in Adolescence: an Observational Study
- ClinicalTrials.gov ID
- NCT07259109
- Acronym / sponsor ID
- PSY25
- Conditions
- Anxiety Disorders, Depressive Disorder, Obsessive-Compulsive Disorder, Mental Health, Adolescent - Emotional Problem, Psychoterapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Comorbid diagnosis of major neuropsychiatric disorders (e.g., autism spectrum disorder, schizophrenia)
- Intelligence Quotient (IQ) ≤ 79
- Lack of signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child Behavior Checklist (CBCL)
Time frame: 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.
SAFA General Screening Scales
Time frame: 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.
Personality Inventory for DSM (PID)
Time frame: 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).
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 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).
Toronto Alexithymia Scale (TAS-20)
Time frame: 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).
Barratt Impulsiveness Scale (BIS-11)
Time frame: 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).
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Time frame: 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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Depressive Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Behavior Checklist (CBCL) (time frame: Baseline, Month 3, Month 6, Month 9, and Month 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.