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Clinical Trials in Spain / NCT07585955
Active, not recruiting Not applicable

Family Connections Transdiagnostic for Relatives of People With Emotional Dysregulation

NCT07585955 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Valencia
Phase
Not applicable
Started
2026-05-03
Last updated
2026-05-28

Condition(s) studied

Relatives

Investigational drug(s) / intervention(s)

Family Connections Transdiagnostic for relatives of people with emotional dysregulationOptimized Treatment as Usual (TAU-O)

Family Connections Transdiagnostic for relatives of people with emotional dysregulation: The intervention lasts 3 months and includes 12 two-hour sessions in a group format on a weekly basis. The FC-T program is divided into 6 modules: 2 modules of psychoeducation on emotional dysregulation (ED) and 4 modules of Dialectical Behavior Therapy (DBT)-based skills training (relationship mindfulness, emotional regulation, acceptance, validation, and problem management).

Optimized Treatment as Usual (TAU-O): Family members will receive the usual care available in their clinical setting. In addition, they will participate in a single 3-hour group psychoeducation session including the following components: (1) up-to-date information and research on emotional dysregulation (epidemiology, frequency, comorbidity, risk and protective factors); and (2) psychoeducation on the development of emotional dysregulation, explanatory models, and available treatments.

Study summary

The aim of this study is to evaluate the efficacy of the Family Connections Transdiagnostic (FC-T) program in relatives of individuals with psychological disorders associated with emotional dysregulation through a randomized controlled trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * • Being 18 years of age or older. * Being a family member (e.g., parent, partner, sibling, or other close relative) of a patient diagnosed, according to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), with a psychological disorder characterized by emotional dysregulation (e.g., eating disorders, Cluster B personality disorders, or disruptive, impulse-control, and conduct disorders). * The patient must currently be receiving treatment in a participating clinical center. * Having sufficient knowledge and understanding of the Spanish language to complete the assessments and participate in the intervention. * Providing written informed consent to participate in the study. Exclusion Criteria: * • Presence of any severe mental disorder or condition in the family member that may interfere with participation in the intervention (e.g., psychotic disorders, schizophrenia, severe cognitive impairment, or intellectual disability). * Current substance dependence that may hinder participation in the study. * Severe clinical instability in the patient that prevents the family member from participating in the intervention (as judged by clinicians).

Primary outcome measure(s)

  • Record of critical family-patient incidents — Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
    Frequency of problem behaviors in the past 3 months, including suicide attempts, self-harm episodes, visits to psychiatric emergency services, episodes of binge eating, substance use (alcohol or drugs), stealing, fire-setting, verbal aggression, and physical aggression.
  • Burden Assessment Scale (BAS) — Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
    It is a 19-item scale that assesses the caregiver's objective and subjective burden due to the illness of their relative within the past six months using a 4-point Likert scale ranging from 1 (not at all) to 4 (a lot). Higher scores indicate greater caregiver burden. The scale shows adequate validity and reliability, with Cronbach's alpha coefficients ranging from .89 to .91.

Trial sites (1)

FacilityCityRegionStatus
University of Valencia Valencia Valencia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07585955 on ClinicalTrials.gov ↗ ← All trials in Spain