About this trial
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 emotional regulation processes and common factor of the intervention itself are involved in the therapeutic improvement.
The investigators will compare the interventions of four groups: ultra-brief group treatment (1), 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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Group ultra-brief transdiagnostic cognitive-behavioral therapy
BehavioralThis 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 therapy
BehavioralThis 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 therapy
BehavioralParticipants 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 relaxation
BehavioralThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
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).
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.
Secondary outcomes
Cognitive Emotional Regulation Questionnaire (CERQ-27)
It is a 27-item instrument (3 items for each subscale) that measures the following cognitive strategies of emotional regulation: self-blame, acceptance, rumination, refocusing on planning, positive reappraisal, putting into perspective, catastrophizing, and blaming others. Its psychometric properties are adequate, with a Cronbarch's α for each subscale between 0.73 and 0.88.
Common Factor Scale (MPOQ)
This 14-item scale measures six different domains of common factors: task agreement, goal agreement, therapist empathy, therapist experience, treatment credibility, and expectations. The items are scored from 1 (strongly disagree) to 7 (strongly agree). This scale has two underlying factors, "Confidence in the therapist" and "Confidence in the treatment", which show an excellent internal consistency (α=.924 and α=.828, respectively).
Working Alliance Inventory-Short Form Patient version (WAI-S-P)
We use the Bonding subscale from Working Alliance Inventory-Short Form Patient version. It consists of four items with 7 response options that score from 1 (never) to 7 (always). This scale has an excellent internal consistency (α=.93).
Psychological Outcome Profiles (PSYCHLOPS)
Psychological Outcome Profiles is a individualized patiet-reported outcome measure that measures psychological distress. It includes four items covering three domains: (1) Problems (two free-text patient-generated items regarding the two problems that trouble him/her most, questions Q1 and Q2); (2) Function (one free-text patient-generated item corresponding to what has become hardest to do because of his/her problem(s), question Q3); and (3) Well-being (pre-set standardized item about how the patient felt in him/herself in the previous week, question Q4). Items are scored for intensity on a 6-point rating scale (from "Not affected at all" to "Severely affected") and for duration (from "Under 1 month" to "Over 5 years"). PSYCHLOPS total scoring is obtained by summing the scores of the four severity scales (Q1b, Q2b, Q3b, and Q4). PSYCHLOPS has good internal consistency (α = .82).
Sponsors and contacts
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Universidad de Córdoba
Lead sponsor
State Research Agency, Spain
Collaborator
Hospital Universitario Reina Sofia de Cordoba
Collaborator