Clinical trial NCT04289740: Transdiagnostic Group Cognitive Behavioral Therapy (PsicAP-A) for Adolescents With Emotional Disorders
Official title: Transdiagnostic Group Cognitive Behavioral Therapy Versus Group Relaxation Therapy for Adolescents With Emotional Disorders (PsicAP-A): Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Disorder
Keywords: emotional disorders
cognitive behavioural therapy
adolescents
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
Collaborators: name: Hospital de laredo
name: Hospital Sierrallana
First posted: 2020-02-28
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: 12 month follow-up period.
measure: Depressive symptoms
timeFrame: 12 month follow-up period.
measure: Anxiety symptoms
timeFrame: 12 month follow-up period.
measure: Anxiety symptoms
timeFrame: 12 month follow-up period.
Secondary outcomes:
measure: the Quality of life
timeFrame: 12 month follow-up period.
measure: Somatizations
timeFrame: 12 month follow-up period.
measure: Rumination
timeFrame: 12 month follow-up period.
measure: Pathological worry
timeFrame: 12 month follow-up period.
measure: Attentional and interpretative biases
timeFrame: 12 month follow-up period.
measure: Emotional regulation
timeFrame: 12 month follow-up period.
measure: Metacognitive beliefs
timeFrame: 12 month follow-up period.
Other outcomes:
Locations:
city: Girona
country: Spain
facility: centro salud mental Girones
city: Girona
country: Spain
facility: Centro Salud Mental Selva Marítima
city: Laredo
country: Spain
facility: Hospital de Laredo
city: Torrelavega
country: Spain
facility: Hospital Sierrallana
Study officials:
References: