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

Not Applicable

• Conditions: Emotional Disorder
• Interventions: 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

• Registration Number: NCT04289740
• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2022-03
• Study Start: 2022-04-01
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-21
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
relaxation therapy	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.
cognitive-bahavioral therapy	7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals	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.

Primary Outcome Measures

Name	Time	Method
Anxiety symptoms	12 month follow-up period.	Spence Children Anxiety Scale, short version (SCAS-S). It consists of 19 items, ranging from 0 to 3, as follows: 0 = "never", 1 = "sometimes", 2 = "many times", 3 =" always". Total scores range from 0-57 points. Higher scores means a worse outcome.
Depressive symptoms	12 month follow-up period.	Children's Depression Inventory, short version (CDI-S). Consists of 10 items answered on a three-point scale, where 0 = absence of the symptom, 1 = moderate symptom, and 2 = severe symptom. The total score ranges from 0 to 20. Higher scores means a worse outcome

Secondary Outcome Measures

Name	Time	Method
Rumination	12 month follow-up period.	Ruminative Responses Scales (RRS), brooding subscale. It is composed of 5 Likert response items, ranging from 1 to 4 points. (Total score range: 5-20). Higher scores means a worse outcome.
the Quality of life	12 month follow-up period.	KIDSCREEN-10 index. It is composed of 10 Likert response items, ranging from 1 to 5 points. (Total score range: 10-50). Higher scores means a better outcome.
Attentional and interpretative biases	12 month follow-up period.	Inventory of Cognitive Activity in Anxiety Disorders (IACTA), abbreviated 5-item version. It is composed of 5 Likert response items, ranging from 0 to 4 points. (Total score range: 0-20). Higher scores means a worse outcome.
Somatizations	12 month follow-up period.	PHQ-15. is composed of 15 Likert response items, ranging from 0 to 2 points. (Total score range: 0-30). Higher scores means a worse outcome.
Pathological worry	12 month follow-up period.	Penn State Worry Questionnaire (PSWQ), reduced 8-item version. It is composed of 8 Likert response items, ranging from 1 to 5 points. (Total score range: 5-40). Higher scores means a worse outcome.
Metacognitive beliefs	12 month follow-up period.	Metacognitions Questionnaire (MCQ-30); the 6-item negative metacognitive beliefs subscale.; It is composed of 6 Likert response items, ranging from 1 to 4 points. (Total score range: 6-24). Higher scores means a worse outcome.
Emotional regulation	12 month follow-up period.	Emotion Regulation Questionnaire (ERQ). It is composed of 10 Likert response items, ranging from 1 to 7 points. It assess two emotion-regulation strategies: cognitive reappraisal (6 items; range 6-42; higher scores means a better outcome) and expressive suppression (4 items; range 4-28: higher scores means a worse outcome)

Trial Locations

Locations (4)

Centro Salud Mental Selva Marítima; 🇪🇸 Girona, Spain

Hospital de Laredo; 🇪🇸 Laredo, Spain

Hospital Sierrallana; 🇪🇸 Torrelavega, Spain

centro salud mental Girones; 🇪🇸 Girona, Spain