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

Transdiagnostic Group Cognitive Behavioral Therapy Versus Group Relaxation Therapy for Adolescents With Emotional Disorders (PsicAP-A): Protocol

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Girona, Spain
    • Not yet recruiting
    • centro salud mental Girones
    • Contact: Neus Ferras
  • Girona, Spain
    • Recruiting
    • Centro Salud Mental Selva Marítima
    • Contact: devora fuentes, f; Phone Number: 942203389; Email: eclinicos5@idival.org
  • Laredo, Spain
    • Not yet recruiting
    • Hospital de Laredo
    • Contact: Amador Pierre
    • Principal Investigator: Alberto Elices
  • Torrelavega, Spain
    • Not yet recruiting
    • Hospital Sierrallana
    • Contact: maria ruiz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Patient Health Questionnaire - 9 item (PHQ-9), adolescent version. Nine items assessing depressive symptoms with Likert response with values ranging from 0 to 3 (Total score range: 0-27; higher scores means a worse outcome)	12 month follow-up period.
Depressive symptoms	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	12 month follow-up period.
Anxiety symptoms	Generalized Anxiety Disorder - 7 item (GAD-7). It is composed of 7 Likert response items, ranging from 0 to 3 points (Total score range: 0-21). Higher scores means a worse outcome.	12 month follow-up period.
Anxiety symptoms	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.	12 month follow-up period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Quality of life	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.	12 month follow-up period.
Somatizations	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.	12 month follow-up period.
Rumination	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.	12 month follow-up period.
Pathological worry	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.	12 month follow-up period.
Attentional and interpretative biases	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.	12 month follow-up period.
Emotional regulation	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)	12 month follow-up period.
Metacognitive beliefs	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.	12 month follow-up period.

Collaborators and Investigators

• Sponsor: Instituto de Investigación Marqués de Valdecilla
• Collaborators: Hospital de laredo; Hospital Sierrallana

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: adolescents; cognitive behavioural therapy; emotional disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Mood Disorders
• Other Study ID Numbers: PsicAP-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No