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RECRUITING Not applicable ClinicalTrials.gov

Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders

Sponsor: Universidad de Córdoba • ClinicalTrials.gov ID: NCT06909669

Registry updated: 2026-10-02
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Description

The main objective of this randomized clinical trial is to study if various modalities of brief (eight sessions) and ultra-brief (four sessions) transdiagnostic cognitive-behavioral treatment work for decrease emotional symptoms and disorders, as well as to find out which emotional regulation processes and common factor of the intervention itself are involved in the therapeutic improvement. The investigators will compare the interventions of four groups: ultra-brief group treatment (1), brief group treatment (2), ultra-brief individual treatment (3) with the ultra-brief relaxation (control) group. The main questions the study aims to answer are: * Will the brief and ultra-brief treatment formats works better than the relaxation-based control group? * Will results obtained between the brief group therapy group and the ultra-brief group therapy group be similar? * Will the individual ultra brief therapy be more effective than the two group therapies because of common factors, such as the therapeutic alliance? * Will group therapies be more beneficial for cost and in terms of capability to reduce emocional symptoms than individual therapy? Participants will be randomly assigned to each of the groups and will receive the corresponding treatment, with different number of sessions. They will answer a series of questionnaires at the beginning and at the end of the intervention, as well as 3 months and 6 months after the end of the treatment.

Interventions

  • Group ultra-brief transdiagnostic cognitive-behavioral therapy (Behavioral)
    This intervention consists of a four-session ultra-brief TD-CBT delivered in person in a group format. Sessions are held weekly or biweekly and include four therapeutic components based on both their established use: psychoeducation, emotion regulation, behavioral activation, and problem-solving. Session 1 focuses on treatment engagement, personal goals, psychoeducation on emotions, and behavioral activation. Session 2 addresses the relationship between situations, thoughts, and emotions, cognitive flexibility, and identification of overt and covert avoidance patterns. Session 3 introduces graded emotional and situational exposure as an alternative to avoidance and provides structured problem-solving skills. Session 4 reviews and consolidates the skills acquired, reinforces therapeutic gains, and focuses on maintaining progress and preventing relapse. Participants receive practical exercises and between-session activities to support the application of therapeutic skills in daily lifes.
  • Group brief transdiagnostic cognitive-behavioral therapy (Behavioral)
    This intervention consists of an eight-session extended version of the transdiagnostic cognitive-behavioral treatment, retaining the same core therapeutic components while allowing additional time for skill practice and consolidation. Sessions are delivered in person in a group format by trained psychologists, last approximately 90 minutes, and are held weekly or every two weeks. Session 1 focuses on treatment introduction and psychoeducation about emotions; Session 2 on psychoeducation and behavioral activation; Session 3 on cognitive assessment, cognitive restructuring, and emotional awareness; Session 4 on emotional avoidance and emotion-driven behaviors; Sessions 5-6 on emotional and situational exposure and problem-solving; and Sessions 7-8 on review and consolidation of therapeutic skills, reinforcement of progress, and relapse prevention. Between-session practice is encouraged throughout the intervention.
  • Individual ultra-brief transdiagnostic cognitive-behavioral therapy (Behavioral)
    Participants assigned to the individual treatment will receive the same four-session ultra-brief transdiagnostic cognitive-behavioral treatment as the group format, adapted for individual delivery. Sessions last approximately 60 minutes, and are held weekly or every two weeks. The intervention includes psychoeducation, emotion regulation, behavioral activation, and problem-solving. The individual format allows therapeutic content, examples, and exercises to be tailored to each participant's specific difficulties, symptoms, and personal goals. It also allows for personalised feedback and greater emphasis on the therapeutic relationship while maintaining the structured and transdiagnostic nature of the intervention. Participants receive the same printed workbook and may complete optional between-session activities to support the application of therapeutic skills in daily life.
  • Group relaxation (Behavioral)
    This intervention consists of a four-session group-based progressive muscle relaxation program based on Jacobson's relaxation technique. Sessions are delivered in person by trained psychologists, last approximately 90 minutes, and are held weekly. Each session combines brief psychoeducation, guided relaxation practice, discussion of participants' experiences, and instructions for home practice. Session 1 introduces relaxation techniques and trains four muscle groups of the upper extremities. Session 2 reviews previous practice and introduces six muscle groups involving the head, neck, and trunk. Session 3 reviews previous exercises and trains six muscle groups of the lower extremities. Session 4 reviews home practice and includes a complete relaxation exercise involving all 16 muscle groups. Participants are encouraged to practise the techniques between sessions and after completion of the program.

Eligibility criteria

Inclusion Criteria: \- Patients presenting mild or moderate emotional symptomatology (anxiety, depression or somatizations). Specifically, they will be included in the study if they present a score ≥ 5 on the PHQ-9, the GAD-7 or the PHQ-15. Exclusion Criteria: * Bipolar disorder, personality disorder, psychosis or substance abuse, indicated by SCID-5-CV * Recent suicide attempt. * Severe emotional symptoms (PHQ-15 or GAD-7 ≥ 15; or PHQ-9 ≥ 20).

Conditions

Depression - Major Depressive Disorder Generalized Anxiety Disorder Generalized Anxiety Anxiety Somatoform Disorders Somatic Symptom Disorder (DSM-5) Somatization Emotional Disorders

Locations

  • Unidad de Salud Mental del Hospital Universitario Reina Sofía — Córdoba, Córdoba, Spain
  • Unidad de Atención Psicológica (UNAP) de la Universidad de Córdoba — Córdoba, Córdoba, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record