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

Instituto de Investigación Marqués de Valdecilla

Status: Unknown

Conditions: Emotional Disorder

Treatments: Behavioral: a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.; Behavioral: 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals

Study type: Interventional

Funder types: Other

Identifiers

NCT04289740

PsicAP-A

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

cognitive-bahavioral therapy

Experimental group

Description:

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.

Treatment:

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

relaxation therapy

Active Comparator group

Description:

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.

Treatment:

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