NCT04289740

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 11, 2020

Last Update Submit

April 13, 2022

Conditions

Emotional Disorder

Keywords

emotional disorderscognitive behavioural therapyadolescents

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • the Quality of life

    12 month follow-up period.

  • Somatizations

    12 month follow-up period.

  • Rumination

    12 month follow-up period.

  • Pathological worry

    12 month follow-up period.

  • Attentional and interpretative biases

    12 month follow-up period.

  • +2 more secondary outcomes

Study Arms (2)

cognitive-bahavioral therapy

EXPERIMENTAL

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

relaxation therapy

ACTIVE COMPARATOR

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.

Interventions

7 sessions (1.5 hr/session) in groups of approximately 8-10 individualsBEHAVIORAL

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

cognitive-bahavioral therapy
a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.BEHAVIORAL

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.

relaxation therapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

centro salud mental Girones

Girona, Spain

NOT YET RECRUITING

Centro Salud Mental Selva Marítima

Girona, Spain

RECRUITING

Hospital de Laredo

Laredo, Spain

NOT YET RECRUITING

Hospital Sierrallana

Torrelavega, Spain

NOT YET RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 28, 2020

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

April 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)