Transdiagnostic Group Cognitive Behavioral Therapy Versus Group Relaxation Therapy for Adolescents With Emotional Disorders (PsicAP-A): Protocol
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Emotional Disorder
- Sponsor
- Instituto de Investigación Marqués de Valdecilla
- Enrollment
- 160
- Locations
- 4
- Primary Endpoint
- Anxiety symptoms
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Anxiety symptoms
Time Frame: 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
Time Frame: 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 Outcomes
- Rumination(12 month follow-up period.)
- the Quality of life(12 month follow-up period.)
- Attentional and interpretative biases(12 month follow-up period.)
- Somatizations(12 month follow-up period.)
- Pathological worry(12 month follow-up period.)
- Metacognitive beliefs(12 month follow-up period.)
- Emotional regulation(12 month follow-up period.)