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

Emotional Disorder Clinical Trial

— PsicAP-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04289740
• Other study ID #: PsicAP-A
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2022
• Source: Instituto de Investigación Marqués de Valdecilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Emotional Disorder
• Mood Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	centro salud mental Girones	Girona
Spain	Centro Salud Mental Selva Marítima	Girona
Spain	Hospital de Laredo	Laredo
Spain	Hospital Sierrallana	Torrelavega

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Investigación Marqués de Valdecilla	Hospital de laredo, Hospital Sierrallana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.