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

Primary Purpose

Emotional Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals
a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.
Sponsored by
Instituto de Investigación Marqués de Valdecilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Disorder focused on measuring emotional disorders, cognitive behavioural therapy, adolescents

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • centro salud mental Girones
  • Centro Salud Mental Selva MarítimaRecruiting
  • Hospital de Laredo
  • Hospital Sierrallana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cognitive-bahavioral therapy

relaxation therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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)
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.

Full Information

First Posted
February 11, 2020
Last Updated
April 13, 2022
Sponsor
Instituto de Investigación Marqués de Valdecilla
Collaborators
Hospital de laredo, Hospital Sierrallana
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1. Study Identification

Unique Protocol Identification Number
NCT04289740
Brief Title
Transdiagnostic Group Cognitive Behavioral Therapy (PsicAP-A) for Adolescents With Emotional Disorders
Acronym
PsicAP-A
Official Title
Transdiagnostic Group Cognitive Behavioral Therapy Versus Group Relaxation Therapy for Adolescents With Emotional Disorders (PsicAP-A): Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Marqués de Valdecilla
Collaborators
Hospital de laredo, Hospital Sierrallana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disorder
Keywords
emotional disorders, cognitive behavioural therapy, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cognitive-bahavioral therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
relaxation therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
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)
Time Frame
12 month follow-up period.
Title
Depressive symptoms
Description
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
Time Frame
12 month follow-up period.
Title
Anxiety symptoms
Description
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.
Time Frame
12 month follow-up period.
Title
Anxiety symptoms
Description
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.
Time Frame
12 month follow-up period.
Secondary Outcome Measure Information:
Title
the Quality of life
Description
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.
Time Frame
12 month follow-up period.
Title
Somatizations
Description
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.
Time Frame
12 month follow-up period.
Title
Rumination
Description
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.
Time Frame
12 month follow-up period.
Title
Pathological worry
Description
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.
Time Frame
12 month follow-up period.
Title
Attentional and interpretative biases
Description
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.
Time Frame
12 month follow-up period.
Title
Emotional regulation
Description
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)
Time Frame
12 month follow-up period.
Title
Metacognitive beliefs
Description
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.
Time Frame
12 month follow-up period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
centro salud mental Girones
City
Girona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neus Ferras
Facility Name
Centro Salud Mental Selva Marítima
City
Girona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
devora fuentes, f
Phone
942203389
Email
eclinicos5@idival.org
Facility Name
Hospital de Laredo
City
Laredo
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amador Pierre
First Name & Middle Initial & Last Name & Degree
Alberto Elices
Facility Name
Hospital Sierrallana
City
Torrelavega
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
maria ruiz

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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