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Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders

No phase Interventional Depression - Major Depressive Disorder Generalized Anxiety Disorder Generalized Anxiety Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group brief transdiagnostic cognitive-behavioral therapy, Group relaxation, Group ultra-brief transdiagnostic cognitive-behavioral therapy, Individual ultra-brief transdiagnostic cognitive-behavioral treatment format.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Generalized Anxiety Disorder, Generalized Anxiety, Anxiety. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Ultra-brief Psychological Treatments for Emocional Symptoms and Disorders: An Efficacy and Efficiency Analysis

Overview

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.

Interventions

  • Behavioral Group brief transdiagnostic cognitive-behavioral therapy
    Eight-session treatment based on Barlow's Unified Protocol. These sessions include: improving motivation and commitment to treatment, understanding the functioning of emotions, emotional awareness training, developing more flexible and adaptive thinking patterns, reduction of emotional avoidance and emotion-driven behaviors; awareness and tolerance of physical sensations; interoceptive and situational emotional exposure; achievement, maintenance and relapse prevention. In addition, the intervent
  • Behavioral Group relaxation
    The participants in this group will receive basic training in Jacobson's progressive relaxation with a similar periodicity to the ultra-brief intervention.
  • Behavioral Group ultra-brief transdiagnostic cognitive-behavioral therapy
    This intervention consists of a four-session version of the brief transdiagnostic treatment (Experimental group 1). The reduced format preserves the principal treatment modules, including psychoeducation, emotion regulation, behavioral activation, and problem-solving.The reduction is achieved by combining sessions 1 and 2, eliminating 3 and 6 and combining sessions 7 and 8. Treatment groups will consist of 8-10 people. Each session will have a duration of 1.5 hours and the intervention will be c
  • Behavioral Individual ultra-brief transdiagnostic cognitive-behavioral treatment format
    Participants of this group, wil receive the same treatment than group 2 (ultra-brief transdiagnostic cognitive-behavioraltreatment in group format) but individual format. Each session will have a duration of 1 hour and the intervention will be carried out on a weekly basis, with a maximum duration of four weeks.

Primary outcome measures

  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
  • Generalized Anxiety Disorder Scale (GAD-7) [Time frame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
  • Patient Health Questionnaire-15 (PHQ-15) [Time frame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
  • Structured Clinical Interview for DSM-5, Clinical Version (SCID-5-CV) [Time frame: Baseline and post-treatment (two weeks after the end of treatment).]
Secondary outcome measures (8)
  • Cognitive Emotional Regulation Questionnaire (CERQ-27) [Time frame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
  • Common Factor Scale (MPOQ) [Time frame: Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).]
  • Working Alliance Inventory-Short Form Patient version (WAI-S-P) [Time frame: Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).]
  • Psychological Outcome Profiles (PSYCHLOPS) [Time frame: Baseline and post-treatment (two weeks after the end of treatment).]
  • Satisfaction with therapy [Time frame: Post-treatment (two weeks after the end of treatment).]
  • Sociodemographic data [Time frame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
  • Healthcare use questions [Time frame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
  • Acceptance and Action Questionnaire (AAQ-II) [Time frame: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Unidad de Salud Mental del Hospital Universitario Reina Sofía — Córdoba
  • Unidad de Atención Psicológica (UNAP) de la Universidad de Córdoba — Córdoba

Publications

  • Ruiz, F. J., Suárez-Falcón, J. C., Cárdenas-Sierra, S., Durán, Y., Guerrero, K., & Riaño-Hernández, D. (2016). Psychometric properties of the Acceptance and Action Questionnaire-II in Colombia. The Psychological Record, 66, 429-437. https://doi.org/10.1007/s40732-016-0183-2
  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25. PMID 22035996
  • Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737. PMID 10568646
  • Ros Montalban S, Comas Vives A, Garcia-Garcia M. Validation of the Spanish version of the PHQ-15 questionnaire for the evaluation of physical symptoms in patients with depression and/or anxiety disorders: DEPRE-SOMA study. Actas Esp Psiquiatr. 2010 Nov-Dec;38(6):345-57. Epub 2010 Nov 1. PMID 21188674
  • Munoz-Navarro R, Cano-Vindel A, Moriana JA, Medrano LA, Ruiz-Rodriguez P, Aguero-Gento L, Rodriguez-Enriquez M, Piza MR, Ramirez-Manent JI. Screening for generalized anxiety disorder in Spanish primary care centers with the GAD-7. Psychiatry Res. 2017 Oct;256:312-317. doi: 10.1016/j.psychres.2017.06.023. Epub 2017 Jun 12. PMID 28666201
  • Munoz-Navarro R, Cano-Vindel A, Medrano LA, Schmitz F, Ruiz-Rodriguez P, Abellan-Maeso C, Font-Payeras MA, Hermosilla-Pasamar AM. Utility of the PHQ-9 to identify major depressive disorder in adult patients in Spanish primary care centres. BMC Psychiatry. 2017 Aug 9;17(1):291. doi: 10.1186/s12888-017-1450-8. PMID 28793892
  • Holgado-Tello, F., Amor, P.J., Lasa, A., & Domínguez, J. (2018). Two new brief versions of the cognitive emotion regulation questionnaire and its relationships with depression and anxiety. Anales de Psicología, 34(3), 458-464. https://doi.org/10.6018/analesps.34.3.306531
  • Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8. PMID 20089179

Identifiers

NCT: NCT06909669 · PID2023-152589OB-I00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗