Here we Test Out an Online Compassion Focused Intervention for Adolescents With Social Anxiety Disorder and Analyze Its Effect on (Self)Compassion, Emotion Regulation and Social Anxiety Symptoms, as Well as Heart Rate Variability.

NCT07244198 | Completed

• 2 other identifiers: FCT 2021.05485.BDCEDI/FPCEUC:62/9
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Emotion regulation (ER) is a key competence developed mainly throughout adolescence. According to an evolutionary perspective, threat, drive, and soothing systems interact to achieve ER. Difficulties in ER are transdiagnostic features in different psychopathologies and have been hypothesized as resulting from an unbalance of these ER systems. Research findings support Heart Rate Variability (HRV) as a biomarker of ER in adolescents. Higher HRV associates with adaptive ER; lower HRV associates with difficulties in ER and with both Social Anxiety Disorder (SAD) and Conduct Disorder (CD). This project aims to test for differences in HRV patterns linked to the triggering of different ER systems, contrasting healthy controls with clinical adolescent samples (SAD vs. CD). Compassion-focused interventions have been effective in reducing SAD symptom severity in adults; however, this approach was not tested in pediatric samples. Here we test the efficacy of an online-delivered compassion focused intervention for teens with Social Anxiety Disorder and assess its effect on (self)compassion, fears of compassion, social safeness, emotion regulation and social anxiety symptoms, as well as Heart Rate Variability.

Conditions

Social Anxiety Disorder

Keywords

Heart Rate Variability; Emotion Regulation; Compassion; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (8)

• Emotion Regulation

  Difficulties in Emotion Regulation Scale The DERS-AV is 36-item self-report measure that assesses multiple aspects of difficulties in emotion regulation and is composed of six dimensions: Nonacceptance of Emotional Responses (nonacceptance); Difficulties Engaging in Goal-Directed Behavior (goals); Impulse Control Difficulties (impulse); Lack of Emotional Awareness (awareness); Limited Access to Emotion Regulation Strategies (strategies); and Lack of Emotional Clarity (clarity). Participants are asked to rate in a five-point scale how often the items apply to them from 1 (almost never) to 5 (almost always). Scores range from 36 to 180. Higher scores indicate greater difficulties in emotion regulation.

  From pre-treatment to 3-month follow-up.

• Psychophyiological markers (MeanHR)

  MeanHR (average of heartbeats per minute).

  From pre-treatment to 3-month follow-up.

• Social Anxiety (Social Anxiety Scale - Adolescents)

  SAS-A is a self-report instrument, which assesses adolescents' social anxiety experiences in the context of peer relations. It consists of 22 items, 4 of which are neutral/filler items, to be rated on a 5-point Likert scale according to how often the items apply to the participants, from 1 (not at all) to 5 (all the time). It's composed by three factors: fear of negative evaluation (FNE), social avoidance and distress in new situations (SAD-New), and social avoidance and distress in general (SAD-General). Scores range from 18 to 90. Higher scores indicate a more severe subjective experience of social anxiety.

  From pre-treatment to 3-month follow-up.

• Psychophyiological markers (RMSSD)

  Root Mean Square of Successive Differences between normal heartbeats.

  From pre-treatment to 3-month follow-up.

• Psychophysiological markers (HFms2)

  Heart Rate Variability - High Frequency band in absolute units (ms2).

  From pre-treatment to 3-month follow-up.

• Psychophysiological markers (HFn.u.)

  Heart Rate Variability - High Frequency band, in normalized units (n.u.).

  From pre-treatment to 3-month follow-up

• Psychophysiological markers (LFHF)

  Heart Rate Variability, Low Frequency/High Frequency ratio.

  From pre-treatment to 3-month follow-up.

• Social Anxiety and Avoidance (Social Anxiety and Avoidance Scale for Adolescents)

  Social Anxiety and Avoidance Scale for Adolescents (Cunha, Pinto-Gouveia \& Salvador, 2002) SAASA is a 34-item self-report 5-point Likert-type instrument assessing the degree of anxiety (1=none to 5=very much) and frequency of avoidance (1=never to 5=almost always) in a wide range of social situations, representing the most frequent social fears in adolescence. Both subscales load in 6 factors: interactions in new situations, interaction with the opposite sex, performance in social situations, assertive interaction, observation by others, eating and drinking in public. Scores range from 34 to 170 for anxiety and avoidance, with higher scores meaning more severe anxiety and avoidance experienced by the participant.

  From pre-treatment to 3-month follow-up.

Other Outcomes (4)

• Compassion

  From pre-treatment to 3-month follow-up.

• Self-compassion

  From pre-treatment to 3-month follow-up.

• Social Safeness

  From pre-treatment to 3-month follow-up.

Study Arms (2)

Compassion Focused Therapy Treatment Group

EXPERIMENTAL

These participants get a 10-session online delivered compassion focused therapy intervention.

Behavioral: Compassion Focused Therapy

Control Group

NO INTERVENTION

Waitlist Control Group

Interventions

Compassion Focused Therapy BEHAVIORAL

Online delivered 10-session compassion focused therapy intervention.

Compassion Focused Therapy Treatment Group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Main Diagnosis of Social Anxiety Disorder

You may not qualify if:

• Presence of an externalizing disorder according to the MINI-KID
• Cognitive impairment
• Presence of psychotic symptoms according to the MINI-KID
• Presence of diseases and/or use of substances/medications that alter cardiac functioning
• Body mass index over 30 kg/m2, due to its impact on cardiac functioning
• Illiteracy

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

FPCEUC

Coimbra, Coimbra District, 3000, Portugal

Location

Related Publications (24)

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MeSH Terms

Conditions

Phobia, Social; Emotional Regulation

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)