Social Anxiety DisorderNCT07464561
RESCCUE4 - Group CBT for Social Anxiety in Adolescents
A study testing Group Cognitive Behavioral Therapy and Psychoeducational Group Intervention in people with Social Anxiety Disorder, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
This randomized controlled trial aims to evaluate the efficacy of a 2-month group Cognitive Behavioral Therapy (CBT) intervention compared to a structured psychoeducational treatment as usual (TAU) in adolescents diagnosed with Social Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Group Cognitive Behavioral Therapy and Psychoeducational Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 12 and 17 years
- DSM-5 diagnosis of Social Anxiety Disorder
- Access to the Child and Adolescent Neuropsychiatry Day Hospital
- Willingness of the participant and family to participate in the study
- Written informed consent provided by parents or legal guardians
Who cannot join
- Age below 12 years
- Intellectual disability
- Lack of family compliance with treatment
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REcover Spaces for Traumatized Children in CommUnity sEttings Post COVID-19 (RESCCUE4): A Double-Blind Controlled Trial Comparing Group Cognitive Behavioral Therapy Versus Treatment as Usual in Adolescents With Social Anxiety Disorder
This randomized controlled trial aims to evaluate the efficacy of a 2-month group Cognitive Behavioral Therapy (CBT) intervention compared to a structured psychoeducational treatment as usual (TAU) in adolescents diagnosed with Social Anxiety Disorder.
Participants aged 12 to 17 years will be recruited from the Child and Adolescent Neuropsychiatry Day Hospital at Bambino Gesù Children's Hospital (Rome, Italy).
The primary objective is to assess the reduction of social anxiety symptoms following the CBT intervention compared to TAU. Secondary objectives include improvement in global functioning, interpersonal relationships, emotional regulation, and reduction of social withdrawal. Assessments will be conducted at baseline, post-treatment (2 months), and 1-month follow-up.
Read the detailed description
This monocentric, no-profit randomized controlled trial will enroll 34 adolescents aged 12-17 years with a DSM-5 diagnosis of Social Anxiety Disorder. Participants will be randomly assigned in a 1:1 ratio to either a group Cognitive Behavioral Therapy (CBT) intervention or a structured psychoeducational treatment as usual (TAU). Randomization will be stratified by age (12-14 years; 15-17 years).
Both interventions will consist of eight weekly group sessions (90 minutes each) delivered over a 2-month period.
The CBT intervention includes psychoeducation about social anxiety, identification of maladaptive automatic thoughts, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises based on a subjective distress hierarchy (SUDs), social skills training, metacognitive exercises, and relapse prevention strategies.
The active comparator (TAU) consists of structured group psychoeducational sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies.
Outcome assessments will be conducted at baseline (T0), post-treatment (T2), and at 1-month follow-up (T3) by blinded evaluators. The primary outcome is the change in social anxiety symptoms measured through validated self-report scales. Secondary outcomes include changes in global functioning, interpersonal difficulties, emotional regulation, and general psychopathology.
The study aims to determine whether group CBT provides superior clinical improvement compared to structured psychoeducational treatment in adolescents with Social Anxiety Disorder.
- Conditions
- Social Anxiety Disorder
- Being tested
- Group Cognitive Behavioral Therapy, Psychoeducational Group Intervention
- Keywords
- Cognitive Behavioral Therapy, Adolescents, Group Therapy, Social Withdrawal, Psychoeducation, Anxiety Symptoms
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behavioral TherapyBehavioural
A structured 8-session group Cognitive Behavioral Therapy program delivered weekly over 2 months. Sessions include psychoeducation, identification of maladaptive automatic thoughts, cognitive restructuring, exposure techniques based on a subjective distress hierarchy (SUDs), breathing techniques, social skills training, and relapse prevention.
Psychoeducational Group InterventionBehavioural
A structured 8-session group psychoeducational program delivered weekly over 2 months. Sessions focus on emotional literacy, understanding emotional processes, awareness of somatic manifestations of anxiety, and development of emotion regulation strategies.
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Behavioral Therapy | Experimental | Participants assigned to this arm will receive an 8-week group Cognitive Behavioral Therapy (CBT) intervention consisting of weekly 90-minute sessions. The intervention includes psychoeducation about social anxiety, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises, social skills training, metacognitive exercises, and relapse prevention strategies. Receives: Behavioral: Group Cognitive Behavioral Therapy |
| Structured Psychoeducational Treatment (TAU) | Active comparator | Participants assigned to this arm will receive an 8-week structured group psychoeducational intervention consisting of weekly 90-minute sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies. Receives: Behavioral: Psychoeducational Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Anxiety Symptoms (MASC-2)
Change from baseline to post-treatment in social anxiety symptoms measured by the Multidimensional Anxiety Scale for Children (MASC-2) Social Anxiety T-score.
The MASC-2 is a self-report questionnaire assessing anxiety symptoms in youth. T-scores range from 0 to 100, with higher scores indicating greater anxiety severity.
Measured: Baseline to 2 months and 3 months
Secondary outcomes (2)
Change in Social Anxiety Symptoms (LSAS)
Change from baseline to post-treatment in social anxiety symptoms measured by the Liebowitz Social Anxiety Scale (LSAS). The LSAS assesses fear/anxiety and avoidance across social situations. Scores range from 0 to 144, with higher scores indicating greater social anxiety severity.
Measured: Baseline to 2 months and 3 months
Change in Global Functioning
Change from baseline to post-treatment and 1-month follow-up in global functioning measured by the Children's Global Assessment Scale (C-GAS). Higher scores indicate better functioning.
Measured: Baseline to 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 May 2024
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Paola De Rose, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464561
- Sponsor's protocol ID
- RESCCUE4
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18.
PubMed 32439401Qiu JJ, Yang RZ, Tang YJ, Lin YY, Xu HJ, Zhang N, Liang M, Cai HD, Zeng K, Wu XD. BRD4 and PIN1 gene polymorphisms are associated with high pulse pressure risk in a southeastern Chinese population. BMC Cardiovasc Disord. 2020 Nov 4;20(1):475. doi: 10.1186/s12872-020-01757-x.
PubMed 33148187
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REcover Spaces for Traumatized Children in CommUnity sEttings Post COVID-19 (RESCCUE4): A Double-Blind Controlled Trial Comparing Group Cognitive Behavioral Therapy Versus Treatment as Usual in Adolescents With Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07464561
- Acronym / sponsor ID
- RESCCUE4
- Conditions
- Social Anxiety Disorder
- Keywords
- Cognitive Behavioral Therapy, Adolescents, Group Therapy, Social Withdrawal, Psychoeducation, Anxiety Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 11 Mar 2026 (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 randomized controlled trial aims to evaluate the efficacy of a 2-month group Cognitive Behavioral Therapy (CBT) intervention compared to a structured psychoeducational treatment as usual (TAU) in adolescents diagnosed with Social Anxiety Disorder.
Participants aged 12 to 17 years will be recruited from the Child and Adolescent Neuropsychiatry Day Hospital at Bambino Gesù Children's Hospital (Rome, Italy).
The primary objective is to assess the reduction of social anxiety symptoms following the CBT intervention compared to TAU. Secondary objectives include improvement in global functioning, interpersonal relationships, emotional regulation, and reduction of social withdrawal. Assessments will be conducted at baseline, post-treatment (2 months), and 1-month follow-up.
Detailed description
This monocentric, no-profit randomized controlled trial will enroll 34 adolescents aged 12-17 years with a DSM-5 diagnosis of Social Anxiety Disorder. Participants will be randomly assigned in a 1:1 ratio to either a group Cognitive Behavioral Therapy (CBT) intervention or a structured psychoeducational treatment as usual (TAU). Randomization will be stratified by age (12-14 years; 15-17 years).
Both interventions will consist of eight weekly group sessions (90 minutes each) delivered over a 2-month period.
The CBT intervention includes psychoeducation about social anxiety, identification of maladaptive automatic thoughts, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises based on a subjective distress hierarchy (SUDs), social skills training, metacognitive exercises, and relapse prevention strategies.
The active comparator (TAU) consists of structured group psychoeducational sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies.
Outcome assessments will be conducted at baseline (T0), post-treatment (T2), and at 1-month follow-up (T3) by blinded evaluators. The primary outcome is the change in social anxiety symptoms measured through validated self-report scales. Secondary outcomes include changes in global functioning, interpersonal difficulties, emotional regulation, and general psychopathology.
The study aims to determine whether group CBT provides superior clinical improvement compared to structured psychoeducational treatment in adolescents with Social Anxiety Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Behavioral Therapy | Experimental | Behavioral: Group Cognitive Behavioral TherapyParticipants assigned to this arm will receive an 8-week group Cognitive Behavioral Therapy (CBT) intervention consisting of weekly 90-minute sessions. The intervention includes psychoeducation about social anxiety, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises, social skills training, metacognitive exercises, and relapse prevention strategies. |
| Structured Psychoeducational Treatment (TAU) | Active comparator | Behavioral: Psychoeducational Group InterventionParticipants assigned to this arm will receive an 8-week structured group psychoeducational intervention consisting of weekly 90-minute sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 12 and 17 years
- DSM-5 diagnosis of Social Anxiety Disorder
- Access to the Child and Adolescent Neuropsychiatry Day Hospital
- Willingness of the participant and family to participate in the study
- Written informed consent provided by parents or legal guardians
Key exclusion criteria (4 listed)
- Age below 12 years
- Intellectual disability
- Lack of family compliance with treatment
- Withdrawal of 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Cognitive Behavioral TherapyA structured 8-session group Cognitive Behavioral Therapy program delivered weekly over 2 months. Sessions include psychoeducation, identification of maladaptive automatic thoughts, cognitive restructuring, exposure techniques based on a subjective distress hierarchy (SUDs), breathing techniques, social skills training, and relapse prevention. | Behavioural | Group Cognitive Behavioral Therapy |
| Psychoeducational Group InterventionA structured 8-session group psychoeducational program delivered weekly over 2 months. Sessions focus on emotional literacy, understanding emotional processes, awareness of somatic manifestations of anxiety, and development of emotion regulation strategies. | Behavioural | Structured Psychoeducational Treatment (TAU) |
Primary outcome
Change in Social Anxiety Symptoms (MASC-2)
Time frame: Baseline to 2 months and 3 months
Change from baseline to post-treatment in social anxiety symptoms measured by the Multidimensional Anxiety Scale for Children (MASC-2) Social Anxiety T-score. The MASC-2 is a self-report questionnaire assessing anxiety symptoms in youth. T-scores range from 0 to 100, with higher scores indicating greater anxiety severity.
2 secondary outcomes
Change in Social Anxiety Symptoms (LSAS)
Time frame: Baseline to 2 months and 3 months
Change in Global Functioning
Time frame: Baseline to 2 months and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 32439401Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18.
- Background: PubMed 33148187Qiu JJ, Yang RZ, Tang YJ, Lin YY, Xu HJ, Zhang N, Liang M, Cai HD, Zeng K, Wu XD. BRD4 and PIN1 gene polymorphisms are associated with high pulse pressure risk in a southeastern Chinese population. BMC Cardiovasc Disord. 2020 Nov 4;20(1):475. doi: 10.1186/s12872-020-01757-x.
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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. This study is not recruiting at the moment.
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?
A study testing Group Cognitive Behavioral Therapy and Psychoeducational Group Intervention in people with Social Anxiety Disorder, run by Bambino Gesù Hospital and Research Institute 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 11 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Social Anxiety Symptoms (MASC-2) (time frame: Baseline to 2 months and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07464561, which also lists 2 linked publications.
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 11 Mar 2026.