Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders

NCT06909669 | Not Yet Recruiting

• 1 other identifier: PID2023-152589OB-I00
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire-9 (PHQ-9)

  The PHQ-9 is the depression module of the PHQ, that scores the 9 DSM-IV depression criteria present in the last two weeks from 0 ("not at all") to 3 ("nearly every day"). A score of 10 is usually set as the cut-off point for major depression disorder (MDD): a score of 10-14 indicates minor depression, moderate MDD, or dysthymia; 15-19, moderately severe MDD; and 20-27, severe MDD. This tool has been tested in Spanish primary care centres (McDonald's ω = .89).

  Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)

• Generalized Anxiety Disorder Scale (GAD-7)

  The GAD-7 assesses common anxiety symptoms in the last two weeks, scoring from 0 ("not at all") to 3 ("nearly every day"). Cut points of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively. The algorithm sets 8 as the cut point for GAD, however it has been found that a score of 10 is more optimal. We will use a version validated in Spanish, that was recently tested in primary care centres (Cronbach's α = .83).

  Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)

• Patient Health Questionnaire-15 (PHQ-15)

  The PHQ-15 is the somatization module of the PHQ. It includes 13 somatic symptoms plus 2 from the PHQ-9 (sleeping problems and fatigue). Scores of 5, 10, and 15 represent low, medium, and high somatic symptom severity, respectively. To screen a somatization disorder, whereas the original algorithm needs of at least a score of 2 in three or more somatic symptoms (sensitivity of 78% and specificity of 71%), the cut point usually used is 10; nevertheless, since this can be obtained with ten symptoms of mild severity, we decided to join both criteria to screen the disorder. Furthermore, an absence of biological cause is also often required (since PHQ-15 does not distinguish between medically explained and unexplained symptoms), but the self-administered nature of the PHQ-15 makes difficult to determine this. The PHQ-15 has been validated with Spanish psychiatric outpatients (α = .78).

  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)

  Structured Clinical Interview for DSM-5, Clinical Version (SCID-5-CV), is an interview commonly used to diagnose mental disorders according to the DSM-5 criteria. It is administered by a clinician or trained mental heatlh professional who is familiar with the DSM-5 classification and diagnostic criteria. We will use only the diagnostic criteria to evaluate the existence or not of Major Depressive Episode, Generalized Anxiety Disorder and to exclude the existence of other disorders such as Bipolar Disorder, psychotic disorders, substance use and personality disorder.

  Baseline and post-treatment (two weeks after the end of treatment).

Secondary Outcomes (8)

• Cognitive Emotional Regulation Questionnaire (CERQ-27)

  Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)

• Common Factor Scale (MPOQ)

  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)

  Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).

• Psychological Outcome Profiles (PSYCHLOPS)

  Baseline and post-treatment (two weeks after the end of treatment).

• Satisfaction with therapy

  Post-treatment (two weeks after the end of treatment).

Study Arms (4)

Group 1: Group brief TD-CBT

EXPERIMENTAL

Behavioral: Group brief transdiagnostic cognitive-behavioral therapy

Group 2: Group ultra-brief TD-CBT

EXPERIMENTAL

Behavioral: Group ultra-brief transdiagnostic cognitive-behavioral therapy

Group 3: Individual ultra-brief TD-CBT

EXPERIMENTAL

Behavioral: Individual ultra-brief transdiagnostic cognitive-behavioral treatment format

Group 4: relaxation

ACTIVE COMPARATOR

Behavioral: Group relaxation

Interventions

Group brief transdiagnostic cognitive-behavioral therapy BEHAVIORAL

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 intervention incorporates modules on behavioral activation and problem-solving.

Group 1: Group brief TD-CBT

Group relaxation BEHAVIORAL

The participants in this group will receive basic training in Jacobson's progressive relaxation with a similar periodicity to the ultra-brief intervention.

Group 4: relaxation

Group ultra-brief transdiagnostic cognitive-behavioral therapy BEHAVIORAL

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 carried out on a weekly basis, with a maximum duration of four weeks.

Group 2: Group ultra-brief TD-CBT

Individual ultra-brief transdiagnostic cognitive-behavioral treatment format BEHAVIORAL

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.

Group 3: Individual ultra-brief TD-CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de Córdoba: lead
• State Research Agency, Spain: collaborator
• University Hospital Reina Sofia, Cordoba: collaborator

Study Sites (2)

Unidad de Salud Mental del Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Unidad de Atención Psicológica (UNAP) de la Universidad de Córdoba

Córdoba, Córdoba, 14071, Spain

Location

Related Publications (13)

• 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

  BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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

  RESULT

• 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 RESULT

• First, M.B., Williams, J.B.W., Kats, R.S., Spitzer, R.(2016). Structured Clinical Interview for DSM-S Disorders-Clinician version (SCID-S-CV). Arlington, VA, American Psychiatric Association,

  RESULT

• Finsrud I, Nissen-Lie HA, Vrabel K, Hostmaelingen A, Wampold BE, Ulvenes PG. It's the therapist and the treatment: The structure of common therapeutic relationship factors. Psychother Res. 2022 Feb;32(2):139-150. doi: 10.1080/10503307.2021.1916640. Epub 2021 May 2.

  PMID: 33938407 RESULT

• Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.

  PMID: 11485122 RESULT

• Ashworth, M., Shepherd, M., Christey, J., Matthews, V., Wright, K., Parmentier, H., Robinson, S., & Godfrey, E. (2004). A client-generated psychometric instrument: the development of 'PSYCHLOPS'. Counselling and Psychotherapy Research, 4, 27-31. https://doi.org/10.1080/14733140412331383913

  RESULT

• Andrade-González, N., y Fernández-Liria, A. (2016). Spanish adaptation of the Working Alliance Inventory-Short (WAI-S). Current Psychology: A Journal for Diverse Perspectives on Diverse Psychological Issues, 35(1), 169-177. https://doi.org/10.1007/s12144-015-9365-3

  RESULT

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders; Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Juan Antonio Moriana Elvira Professor

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Antonio Moriana Elvira Professor

CONTACT

+34 957212093; edmoelj@uco.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicenter randomized controlled trial with pre-post measures and follow-ups.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: April 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

ES (2)