Clinical trial NCT06909669: Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders
Official title: Ultra-brief Psychological Treatments for Emocional Symptoms and Disorders: An Efficacy and Efficiency Analysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Generalized Anxiety Disorder
Generalized Anxiety
Anxiety
Somatoform Disorders
Somatic Symptom Disorder (DSM-5)
Somatization
Emotional Disorders
Keywords: ultra-brief therapy
brief therapy
transdiagnostic therapy
cognitive-behavioral therapy
randomized controled trial
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
Collaborators: name: State Research Agency, Spain
name: University Hospital Reina Sofia, Cordoba
First posted: 2025-04-03
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter randomized controlled trial with pre-post measures and follow-ups.
Primary purpose: TREATMENT

Brief summary: 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 variables of cognition and of the intervention process itself are involved in the therapeutic improvement.

The investigators will compare the interventions of four groups: brief group treatment (1), ultra-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.


Eligibility criteria: Inclusion Criteria:

- Patients presenting negative emotional symptomatology (anxiety, depression or somatizations), mild or moderate. 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).

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
measure: Structured Clinical Interview for DSM-5, Clinical Version (SCID-5-CV)
timeFrame: Baseline and post-treatment (two weeks after the end of treatment).
Secondary outcomes:
measure: Cognitive Emotional Regulation Questionnaire (CERQ-27)
timeFrame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
measure: Common Factor Scale (MPOQ)
timeFrame: Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).
measure: Working Alliance Inventory-Short Form Patient version (WAI-S-P)
timeFrame: Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).
measure: Psychological Outcome Profiles (PSYCHLOPS)
timeFrame: Baseline and post-treatment (two weeks after the end of treatment).
measure: Satisfaction with therapy
timeFrame: Post-treatment (two weeks after the end of treatment).
measure: Sociodemographic data
timeFrame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
measure: Healthcare use questions
timeFrame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
measure: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Unidad de Salud Mental del Hospital Universitario Reina Sofía
city: Córdoba
country: Spain
facility: Unidad de Atención Psicológica (UNAP) de la Universidad de Córdoba
Study officials:
affiliation: Universidad de Córdoba
name: Juan Antonio Moriana Elvira Professor
role: PRINCIPAL_INVESTIGATOR
References:
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