Transdiagnostic Group Cognitive Behavioral Therapy (PsicAP-A) for Adolescents With Emotional Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Emotional disorders such as anxiety and depression are highly prevalent during adolescence and associated with functional impairment that commonly extends into adulthood. In the primary care (PC) setting, these disorders are frequently underdiagnosed and undertreated. Objective: To carry out a prospective, randomized controlled trial (RCT) to test the efficacy of a new transdiagnostic cognitive behavioural group therapy (TD-CBT) protocol for adolescents (age 12 to 18 years) compared to group relaxation therapy (RT). Methods: Two-arm, single-blind, RCT (expected N=160) to compare group TD-CBT for emotional disorders to group RT. The group TD-CBT will be administered in seven sessions (90 min/session) over 12 weeks. Psychological assessments will be carried out at baseline, post-treatment, and at months 3, 6, and 12 after treatment. The assessments will include measures of depression, anxiety, somatization, quality of life, disability, and cognitive-emotional factors. The study will be conducted in two PC centres located in Cantabria, Spain. Discussion: This is the first RCT to evaluate the efficacy of group TD-CBT for emotional disorders in adolescents in the PC setting in Spain. If, as expected, the results confirm the superiority of TD-CBT to conventional RT, the widespread implementation of this new approach-based on scientific evidence obtained in a real-world, primary care setting-could improve treatment outcomes and quality of life in adolescents suffering from anxiety or depression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders

NCT04117464

Anxiety Depression

COMPLETED NA

Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care

NCT04847310

Emotional Disorder Depression Somatoform Disorders +1 more

ACTIVE_NOT_RECRUITING NA

Indicated Prevention Transdiagnostic Intervention for Adolescents At High Risk of Emotional Problems

NCT05252026

Anxiety Disorders and Symptoms Depressive Symptoms

COMPLETED NA

Feasibility of a Group Blended Transdiagnostic CBT Protocol for Emotional Disorders

NCT04008576

Anxiety Disorders Depressive Disorder

COMPLETED NA

Efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents With Moderate Emotional Symptoms in Educational Settings

NCT05322642

Anxiety Disorder Depressive Disorder Emotional Problem +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotional Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cognitive-bahavioral therapy

Trasdiagnotic cognitive-behavioral group therapy: The psychological interventions will be manualized. Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12 week period.

Group Type EXPERIMENTAL

7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals

Intervention Type BEHAVIORAL

Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12 week period

relaxation therapy

The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. This intervention will have the same number of sessions as the experimental intervention and last anywhere from 60 to 90 minutes, depending on the session.

Group Type ACTIVE_COMPARATOR

a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.

Intervention Type BEHAVIORAL

The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. This intervention will have the same number of sessions as the experimental intervention and last anywhere from 60 to 90 minutes, depending on the session.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals

Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12 week period

Intervention Type BEHAVIORAL

a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.

The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. This intervention will have the same number of sessions as the experimental intervention and last anywhere from 60 to 90 minutes, depending on the session.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 12 to 17, inclusive, who present to the PC centre seeking treatment for symptoms of anxiety or depression.
* Scores above the predetermined cut-off points on the GAD-7 (\>= 5) and PHQ-9 (\>= 5).
* Agreement to participate in the study, with written informed consent provided by both patients and parents/guardians.

Exclusion Criteria

* Presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder, and major depressive disorder (PHQ-9\> 20).
* Presence of severe or recent suicide attempts
* Moderate or severe behaviour disorder that could interfere with the dynamics of the therapy groups.
* Presence of a mental disability (IQ \< 75).
* Be receiving psychological treatment or any type of specialized care related to mental health.
* Receiving any psychopharmacological treatment.
* Parents involved in legal litigation due to separation or divorce.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No