Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.
• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
• Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
• Patient Health Questionnaire-15 (PHQ-15) [Срок оценки: 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) [Срок оценки: Baseline and post-treatment (two weeks after the end of treatment).]

Вторичные конечные точки (8)

• Cognitive Emotional Regulation Questionnaire (CERQ-27) [Срок оценки: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
• Common Factor Scale (MPOQ) [Срок оценки: 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) [Срок оценки: Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).]
• Psychological Outcome Profiles (PSYCHLOPS) [Срок оценки: Baseline and post-treatment (two weeks after the end of treatment).]
• Satisfaction with therapy [Срок оценки: Post-treatment (two weeks after the end of treatment).]
• Sociodemographic data [Срок оценки: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
• Healthcare use questions [Срок оценки: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]
• Acceptance and Action Questionnaire (AAQ-II) [Срок оценки: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

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

Публикации

• 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

Идентификаторы

NCT: NCT06909669 · PID2023-152589OB-I00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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