Emotional DisorderPsicAP-ANCT04289740
Transdiagnostic Group Cognitive Behavioral Therapy (PsicAP-A) for Adolescents With Emotional Disorders
A study testing 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals and a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention. in people with Emotional Disorder, run by Instituto de Investigación Marqués de Valdecilla at 4 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Emotional Disorder
- What is being tested?
- 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals and a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Apr 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Not yet recruiting
centro salud mental Girones
Girona
Neus Ferras
- Recruiting
Centro Salud Mental Selva Marítima
Girona
devora fuentes, f, 942203389, eclinicos5@idival.org
- Not yet recruiting
Hospital de Laredo
Laredo
Amador Pierre
Alberto Elices
- Not yet recruiting
Hospital Sierrallana
Torrelavega
maria ruiz
About this study
Official title: 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.
- Conditions
- Emotional Disorder
- Being tested
- 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.
- Keywords
- emotional disorders, cognitive behavioural therapy, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 sessions (1.5 hr/session) in groups of approximately 8-10 individualsBehavioural
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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 month follow-up period.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 12 month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Apr 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de laredo, Hospital Sierrallana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289740
- Sponsor's protocol ID
- PsicAP-A
- Acronym
- PsicAP-A
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Group Cognitive Behavioral Therapy Versus Group Relaxation Therapy for Adolescents With Emotional Disorders (PsicAP-A): Protocol
- ClinicalTrials.gov ID
- NCT04289740
- Acronym / sponsor ID
- PsicAP-A / PsicAP-A
- Conditions
- Emotional Disorder
- Keywords
- emotional disorders, cognitive behavioural therapy, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Collaborators
- Hospital de laredo, Hospital Sierrallana
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive-bahavioral therapy | Experimental | Behavioral: 7 sessions (1.5 hr/session) in groups of approximately 8-10 individualsTrasdiagnotic 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. |
| relaxation therapy | Active comparator | 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 sessions (1.5 hr/session) in groups of approximately 8-10 individualsPatients 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 | Behavioural | 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.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. | Behavioural | relaxation therapy |
Primary outcome
Depressive symptoms
Time frame: 12 month follow-up period.
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
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
Anxiety symptoms
Time frame: 12 month follow-up period.
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
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.
7 secondary outcomes
the Quality of life
Time frame: 12 month follow-up period.
Somatizations
Time frame: 12 month follow-up period.
Rumination
Time frame: 12 month follow-up period.
Pathological worry
Time frame: 12 month follow-up period.
Attentional and interpretative biases
Time frame: 12 month follow-up period.
Emotional regulation
Time frame: 12 month follow-up period.
Metacognitive beliefs
Time frame: 12 month follow-up period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Emotional Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Recruiting
AI-assisted Home-based Intervention for ADHD Children
ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals and a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention. in people with Emotional Disorder, run by Instituto de Investigación Marqués de Valdecilla at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: 12 month follow-up period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.