Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders (UltraPsyBrief)

Universidad de Córdoba

Status: Not yet enrolling

Conditions: Emotional Disorders; Somatoform Disorders; Generalized Anxiety Disorder; Somatic Symptom Disorder (DSM-5); Anxiety; Generalized Anxiety; Somatization; Depression - Major Depressive Disorder

Treatments: Behavioral: Group ultra-brief transdiagnostic cognitive-behavioral therapy; Behavioral: Individual ultra-brief transdiagnostic cognitive-behavioral treatment format; Behavioral: Group relaxation; Behavioral: Group brief transdiagnostic cognitive-behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06909669

PID2023-152589OB-I00

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 4 patient groups

Group 1: Group brief TD-CBT

Experimental group

Treatment:

Behavioral: Group brief transdiagnostic cognitive-behavioral therapy

Group 2: Group ultra-brief TD-CBT

Experimental group

Treatment:

Behavioral: Group ultra-brief transdiagnostic cognitive-behavioral therapy

Group 3: Individual ultra-brief TD-CBT

Experimental group

Treatment:

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

Group 4: relaxation

Active Comparator group

Treatment:

Behavioral: Group relaxation