Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

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

Being tested

Group ultra-brief transdiagnostic cognitive-behavioral therapy, Group brief transdiagnostic cognitive-behavioral therapy, Individual ultra-brief transdiagnostic cognitive-behavioral therapy, Group relaxation

Keywords

ultra-brief therapy, brief therapy, transdiagnostic therapy, cognitive-behavioral therapy, randomized controled trial

Medical subject headings

Generalized Anxiety Disorder, Anxiety Disorders, Somatoform Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Group ultra-brief transdiagnostic cognitive-behavioral therapyBehavioural

  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 therapyBehavioural

  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 therapyBehavioural

  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 relaxationBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

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

2. 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).

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

3. 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).

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

4. 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.

   Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Apr 2025
2. Study start28 Apr 2026
3. Primary completionJun 2028 (estimated)
4. Study completionSep 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (13)Papers the sponsor has linked to this study.
• Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.