Emotional DifficultiesNCT07911111
Acceptance and Commitment Therapy in Adolescents With Emotional Difficulties
A study testing An intervention protocol based on Acceptance and Commitment Therapy (ACT) in people with Emotional Difficulties, run by Juan Miguel Flujas at 1 site in Spain.
Trial summary
This exploratory study aimed to describe pretest-posttest changes in emotional regulation difficulties, processes related to psychological flexibility, and anxiety and depressive symptoms in six adolescents who participated in a school-based intervention grounded in Acceptance and Commitment Therapy (ACT). Read more about this study
- Who is it for?
- Ages 14 to 16 years
- Conditions the study is for
- Emotional Difficulties
- What is being tested?
- An intervention protocol based on Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 22 Jun 2025
- 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 14 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 14-16 years.
- Not receiving psychological support before the intervention began.
- Scoring at or above the cut-off point (≥ 60) on the Emotional Problems Index of the self-report version of the Assessment System for Children and Adolescents (SENA; Fernández-Pinto et al., 2015) for secondary education.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention for Adolescents With Emotional Difficulties Through Acceptance and Commitment Therapy: An Exploratory Case Series Study
This exploratory study aimed to describe pretest-posttest changes in emotional regulation difficulties, processes related to psychological flexibility, and anxiety and depressive symptoms in six adolescents who participated in a school-based intervention grounded in Acceptance and Commitment Therapy (ACT).
Read the detailed description
Background/objectives: Emotional regulation and psychological flexibility have been associated with greater well-being and a lower risk of psychological disorders. Therefore, they have been proposed as relevant variables in interventions with adolescents. This exploratory study aimed to describe pretest-posttest changes in emotional regulation difficulties, processes related to psychological flexibility, and anxiety and depressive symptoms in six adolescents who participated in a school-based intervention grounded in Acceptance and Commitment Therapy (ACT). Method: Six female adolescents aged 14-16 years participated in the study. A pre-experimental design with pretest-posttest assessments and no control group was employed. The intervention consisted of 10 weekly sessions and was delivered in person, while maintaining the naturally occurring groups established within the academic setting. Results: Statistically significant differences with large effect sizes were found in emotional regulation, experiential avoidance, and cognitive fusion (core processes of psychological inflexibility), along with a reduction in anxiety and depressive symptoms at posttest. At the individual level, significant decreases in experiential avoidance, cognitive fusion, and depressive symptoms were observed in a high percentage of participants. Discussion: These preliminary findings suggest that the protocol has potential for use with adolescents experiencing emotional difficulties.
- Conditions
- Emotional Difficulties
- Being tested
- An intervention protocol based on Acceptance and Commitment Therapy (ACT)
- Keywords
- Psychological flexibility, Emotion regulation, Adolescence, Anxiety, Depression
- Medical subject headings
- Emotional Regulation, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An intervention protocol based on Acceptance and Commitment Therapy (ACT)Behavioural
Also called Acceptance and Commitment Therapy (ACT)
This intervention aimed to improve difficulties in emotional regulation, processes associated with psychological flexibility, and anxiety and depressive symptoms through the use of ACT-specific metaphors and experiential exercises, combined with content from Dialectical Behavior Therapy (DBT). The intervention consisted of 10 weekly one-hour sessions, three of which were individual sessions (sessions 1, 5, and 10), while the remaining seven were conducted in a group format. The intervention was delivered face-to-face, respecting the naturally established groups within the academic setting.
| Study group | Role | What they receive |
|---|---|---|
| Single-group | Experimental | Behavioral: An intervention protocol based on Acceptance and Commitment Therapy (ACT).
This intervention aimed to improve difficulties in emotional regulation, processes associated with psychological flexibility, and anxiety and depressive symptoms through the use of ACT-specific metaphors and experiential exercises, combined with content from Dialectical Behavior Therapy (DBT). The intervention consisted of 10 weekly one-hour sessions, three of which were individual sessions (sessions 1, 5, and 10), while the remaining seven were conducted in a group format. The intervention was delivered face-to-face, respecting the naturally established groups within the academic setting. Receives: Behavioral: An intervention protocol based on Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difficulties in Emotion Regulation Scale (DERS; Gómez-Simón et al., 2014)
It is a 36-item scale designed to assess emotion regulation strategies. It comprises six subscales: awareness, impulse control, non-acceptance, goal-directed behavior, emotional clarity, and access to emotion regulation strategies. Cronbach's alpha ranged from .62 to .88
Measured: Change from baseline immediately after the intervention
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y; Valdivia-Salas et al., 2016)
It consists of 17 items comprising two factors: experiential avoidance and cognitive fusion (core processes of psychological inflexibility). Cronbach's alpha ranged from .76 to .87
Measured: Change from baseline immediately after the intervention
The Willingness and Action Measure for Children and Adolescents (WAM-C/A; Cobos-Sánchez et al., 2020)
It consists of 14 items and assesses psychological flexibility through two subscales: willingness to remain in contact with unpleasant experiences and values-based action. Cronbach's alpha ranged from .72 to .81
Measured: Change from baseline immediately after the intervention
The Committed Action Questionnaire (CAQ-8; Escoz-Rodríguez et al., in press) in its 8-item version
Assesses the positive and negative aspects of committed action, defined as an individual's willingness to persist in goal-directed behavior. Cronbach's alpha ranged from .69 to .80
Measured: Change from baseline immediately after the intervention
The Overall Anxiety Severity and Impairment Scale (OASIS; Osma et al., 2022)
It is a five-item unidimensional scale designed to assess the severity of anxiety symptoms and associated functional impairment in specific situations or as a state measure. Cronbach's alpha was .94
Measured: Change from baseline immediately after the intervention
The Overall Depression Severity and Impairment Scale (ODSIS; Osma et al., 2022)
It is a five-item unidimensional scale designed to assess the severity of depressive symptoms and associated functional impairment as a state or in specific situations. Cronbach's alpha was .95
Measured: Change from baseline immediately after the intervention
Secondary outcomes (2)
The Overall Anxiety Severity and Impairment Scale (OASIS; Osma et al., 2022)
It is a five-item unidimensional scale designed to assess the severity of anxiety symptoms and associated functional impairment in specific situations or as a state measure. Cronbach's alpha was .94
Measured: Pre-session assessment (sessions 2-10)
The Overall Depression Severity and Impairment Scale (ODSIS; Osma et al., 2022)
It is a five-item unidimensional scale designed to assess the severity of depressive symptoms and associated functional impairment as a state or in specific situations. Cronbach's alpha was .95
Measured: Pre-session assessment (sessions 2-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Mar 2025
- Primary completion22 Jun 2025
- Study completion22 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Emotional DifficultiesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-experimental design with pretest-posttest measures and no control group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Miguel Flujas
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, State Research Agency, Spain, Ministry of Science and Innovation, Spain
- Responsible party
- Sponsor-investigator, Juan Miguel Flujas, Universidad de Almeria
- Investigators
- Inmaculada Gómez, Full Professor of Psychology, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911111
- Sponsor's protocol ID
- UALPsy003
- Other IDs
- PID2024-159026OB-I00
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not at the moment
Publications
Cobos-Sánchez, L., Flujas-Contreras, J. M., & Gómez, I. (2020). Willingness and Action Measure for Adolescents: psychometric validation in Spanish adolescents. Journal of Contextual Behavioral Science, 15, 46-51. https://doi.org/10.1016/j.jcbs.2019.11.006
Escoz-Rodríguez, I., Flujas-Contreras, J. M., & Gómez, I. (In press). Commitment Action Questionnaire (CAQ-8): Spanish validation in adolescents.
Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A., & del Barrio, V. (2015a). SENA. Sistema de Evaluación de Niños y Adolescentes. Manual de Aplicación, Corrección e Interpretación. TEA Ediciones.
Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A., & del Barrio, V. (2015b). SENA. Sistema de Evaluación de Niños y Adolescentes. Manual Técnico. TEA Ediciones.
Osma J, Martinez-Loredo V, Diaz-Garcia A, Quilez-Orden A, Peris-Baquero O. Spanish Adaptation of the Overall Anxiety and Depression Severity and Impairment Scales in University Students. Int J Environ Res Public Health. 2021 Dec 29;19(1):345. doi: 10.3390/ijerph19010345.
PubMed 35010602Gomez-Simon I, Penelo E, de la Osa N. Factor structure and measurement invariance of the Difficulties Emotion Regulation Scale (DERS) in Spanish adolescents. Psicothema. 2014;26(3):401-8. doi: 10.7334/psicothema2013.324.
PubMed 25069562Valdivia-Salas S, Martin-Albo J, Zaldivar P, Lombas AS, Jimenez TI. Spanish Validation of the Avoidance and Fusion Questionnaire for Youth (AFQ-Y). Assessment. 2017 Oct;24(7):919-931. doi: 10.1177/1073191116632338. Epub 2016 Feb 17.
PubMed 26887809
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Adolescents With Emotional Difficulties Through Acceptance and Commitment Therapy: An Exploratory Case Series Study
- ClinicalTrials.gov ID
- NCT07911111
- Acronym / sponsor ID
- UALPsy003
- Conditions
- Emotional Difficulties
- Keywords
- Psychological flexibility, Emotion regulation, Adolescence, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Juan Miguel FlujasUniversity, hospital or other
- Collaborators
- European Regional Development Fund, State Research Agency, Spain, Ministry of Science and Innovation, Spain
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 22 Jun 2025 (actual)
- First posted
- 2 Nov 2026 (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.
This exploratory study aimed to describe pretest-posttest changes in emotional regulation difficulties, processes related to psychological flexibility, and anxiety and depressive symptoms in six adolescents who participated in a school-based intervention grounded in Acceptance and Commitment Therapy (ACT).
Detailed description
Background/objectives: Emotional regulation and psychological flexibility have been associated with greater well-being and a lower risk of psychological disorders. Therefore, they have been proposed as relevant variables in interventions with adolescents. This exploratory study aimed to describe pretest-posttest changes in emotional regulation difficulties, processes related to psychological flexibility, and anxiety and depressive symptoms in six adolescents who participated in a school-based intervention grounded in Acceptance and Commitment Therapy (ACT). Method: Six female adolescents aged 14-16 years participated in the study. A pre-experimental design with pretest-posttest assessments and no control group was employed. The intervention consisted of 10 weekly sessions and was delivered in person, while maintaining the naturally occurring groups established within the academic setting. Results: Statistically significant differences with large effect sizes were found in emotional regulation, experiential avoidance, and cognitive fusion (core processes of psychological inflexibility), along with a reduction in anxiety and depressive symptoms at posttest. At the individual level, significant decreases in experiential avoidance, cognitive fusion, and depressive symptoms were observed in a high percentage of participants. Discussion: These preliminary findings suggest that the protocol has potential for use with adolescents experiencing emotional difficulties.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-experimental design with pretest-posttest measures and no control group
| Arm | Type | Receives |
|---|---|---|
| Single-group | Experimental | Behavioral: An intervention protocol based on Acceptance and Commitment Therapy (ACT)Behavioral: An intervention protocol based on Acceptance and Commitment Therapy (ACT). This intervention aimed to improve difficulties in emotional regulation, processes associated with psychological flexibility, and anxiety and depressive symptoms through the use of ACT-specific metaphors and experiential exercises, combined with content from Dialectical Behavior Therapy (DBT). The intervention consisted of 10 weekly one-hour sessions, three of which were individual sessions (sessions 1, 5, and 10), while the remaining seven were conducted in a group format. The intervention was delivered face-to-face, respecting the naturally established groups within the academic setting. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 14-16 years.
- Not receiving psychological support before the intervention began.
- Scoring at or above the cut-off point (≥ 60) on the Emotional Problems Index of the self-report version of the Assessment System for Children and Adolescents (SENA; Fernández-Pinto et al., 2015) for secondary education.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| An intervention protocol based on Acceptance and Commitment Therapy (ACT)Also: Acceptance and Commitment Therapy (ACT)This intervention aimed to improve difficulties in emotional regulation, processes associated with psychological flexibility, and anxiety and depressive symptoms through the use of ACT-specific metaphors and experiential exercises, combined with content from Dialectical Behavior Therapy (DBT). The intervention consisted of 10 weekly one-hour sessions, three of which were individual sessions (sessions 1, 5, and 10), while the remaining seven were conducted in a group format. The intervention was delivered face-to-face, respecting the naturally established groups within the academic setting. | Behavioural | Single-group |
Primary outcome
The Difficulties in Emotion Regulation Scale (DERS; Gómez-Simón et al., 2014)
Time frame: Change from baseline immediately after the intervention
It is a 36-item scale designed to assess emotion regulation strategies. It comprises six subscales: awareness, impulse control, non-acceptance, goal-directed behavior, emotional clarity, and access to emotion regulation strategies. Cronbach's alpha ranged from .62 to .88
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y; Valdivia-Salas et al., 2016)
Time frame: Change from baseline immediately after the intervention
It consists of 17 items comprising two factors: experiential avoidance and cognitive fusion (core processes of psychological inflexibility). Cronbach's alpha ranged from .76 to .87
The Willingness and Action Measure for Children and Adolescents (WAM-C/A; Cobos-Sánchez et al., 2020)
Time frame: Change from baseline immediately after the intervention
It consists of 14 items and assesses psychological flexibility through two subscales: willingness to remain in contact with unpleasant experiences and values-based action. Cronbach's alpha ranged from .72 to .81
The Committed Action Questionnaire (CAQ-8; Escoz-Rodríguez et al., in press) in its 8-item version
Time frame: Change from baseline immediately after the intervention
Assesses the positive and negative aspects of committed action, defined as an individual's willingness to persist in goal-directed behavior. Cronbach's alpha ranged from .69 to .80
The Overall Anxiety Severity and Impairment Scale (OASIS; Osma et al., 2022)
Time frame: Change from baseline immediately after the intervention
It is a five-item unidimensional scale designed to assess the severity of anxiety symptoms and associated functional impairment in specific situations or as a state measure. Cronbach's alpha was .94
The Overall Depression Severity and Impairment Scale (ODSIS; Osma et al., 2022)
Time frame: Change from baseline immediately after the intervention
It is a five-item unidimensional scale designed to assess the severity of depressive symptoms and associated functional impairment as a state or in specific situations. Cronbach's alpha was .95
2 secondary outcomes
The Overall Anxiety Severity and Impairment Scale (OASIS; Osma et al., 2022)
Time frame: Pre-session assessment (sessions 2-10)
The Overall Depression Severity and Impairment Scale (ODSIS; Osma et al., 2022)
Time frame: Pre-session assessment (sessions 2-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- BackgroundCobos-Sánchez, L., Flujas-Contreras, J. M., & Gómez, I. (2020). Willingness and Action Measure for Adolescents: psychometric validation in Spanish adolescents. Journal of Contextual Behavioral Science, 15, 46-51. https://doi.org/10.1016/j.jcbs.2019.11.006
- BackgroundEscoz-Rodríguez, I., Flujas-Contreras, J. M., & Gómez, I. (In press). Commitment Action Questionnaire (CAQ-8): Spanish validation in adolescents.
- BackgroundFernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A., & del Barrio, V. (2015a). SENA. Sistema de Evaluación de Niños y Adolescentes. Manual de Aplicación, Corrección e Interpretación. TEA Ediciones.
- BackgroundFernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A., & del Barrio, V. (2015b). SENA. Sistema de Evaluación de Niños y Adolescentes. Manual Técnico. TEA Ediciones.
- Background: PubMed 35010602Osma J, Martinez-Loredo V, Diaz-Garcia A, Quilez-Orden A, Peris-Baquero O. Spanish Adaptation of the Overall Anxiety and Depression Severity and Impairment Scales in University Students. Int J Environ Res Public Health. 2021 Dec 29;19(1):345. doi: 10.3390/ijerph19010345.
- Background: PubMed 25069562Gomez-Simon I, Penelo E, de la Osa N. Factor structure and measurement invariance of the Difficulties Emotion Regulation Scale (DERS) in Spanish adolescents. Psicothema. 2014;26(3):401-8. doi: 10.7334/psicothema2013.324.
- Background: PubMed 26887809Valdivia-Salas S, Martin-Albo J, Zaldivar P, Lombas AS, Jimenez TI. Spanish Validation of the Avoidance and Fusion Questionnaire for Youth (AFQ-Y). Assessment. 2017 Oct;24(7):919-931. doi: 10.1177/1073191116632338. Epub 2016 Feb 17.
- Individual participant dataSharing planned: No. Not at the moment
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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.
Inmaculada Gómez, Full Professor of Psychology principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An intervention protocol based on Acceptance and Commitment Therapy (ACT) in people with Emotional Difficulties, run by Juan Miguel Flujas at 1 site 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 0 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: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difficulties in Emotion Regulation Scale (DERS; Gómez-Simón et al., 2014) (time frame: Change from baseline immediately after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07911111, which also lists 7 linked publications.
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 2 Nov 2026.