Emotional ProblemNCT04001140
Enhancement of Emotion Regulation Skills in Adolescents
A study testing Enhancement of emotion regulation skills in people with Emotional Problem and Behavior Problem, run by University of Cyprus at 1 site in Cyprus.
Trial summary
For the current study, a prevention program is developed and applied to enhance the emotion regulation skills of adolescents. Before and after the application of the prevention program, all participants will be assessed for their emotion regulation ability via questionnaires and a physiological examination in which… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Problem, Behavior Problem
- What is being tested?
- Enhancement of emotion regulation skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Nov 2018to 15 May 2020
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents who have a family member with addiction problems (drug or alcohol use, gambling)
- Adolescents who have a family member with psychological problems (e.g. depression, anxiety disorder, bipolar disorder, etc.)
- Adolescents from stressful family environments (domestic violence, maltreatment, divorce, mourning, etc.)
- Participants are literate in Greek.
Who cannot join
- Adolescents with severe addiction problems themselves (daily or weekly drugs use, such as cocaine, heroin, crystal meth, etc.)
- Adolescents with severe psychopathology (e.g. bipolar disorder, schizophrenia)
- Participants who are not literate in Greek.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancement of Emotion Regulation Skills in Vulnerable Adolescents at Risk for Addictions and Psychopathology Due to Risk Factors in the Family
For the current study, a prevention program is developed and applied to enhance the emotion regulation skills of adolescents. Before and after the application of the prevention program, all participants will be assessed for their emotion regulation ability via questionnaires and a physiological examination in which heart rate and skin conductance will be measured.
Read the detailed description
The purpose of this research is to assess whether a short-term group intervention can enhance the emotion regulation skills of adolescents, when the family environment experiences stressful situations, psychopathology or substance abuse. This study aims to increase intervention effectiveness by examining effective approaches to train a crucial mechanism involved in emotional and behavior problems, which is emotion regulation. This research aims to develop a prevention program focused on the enhancement of adolescents' emotion regulation. Before and after the prevention program, participants will answer questionnaires and do a 5 minute psychophysiology experiment to evaluate their emotion regulation ability with both subjective and objective approaches. This prevention program, which is short-term, entailing 7 sessions, synthesizes techniques from three therapeutic models: Cognitive-Behavioral Therapy, Dialectical-Behavioral Therapy and Acceptance and Commitment Therapy. A short-term intervention was formulated and will be tested in the current study, with which is considered an advancement from previous similar interventions because of this synthesis and specific focus on emotion regulation skills, the lack of which can be considered a transdiagnostic risk factor across many psychological conditions and outcomes, including substance use. The main purpose is to help adolescents to enhance their emotion regulation, with the ultimate goal to decrease their risk of developing addictions and other psychopathology.
According to some classic theories of emotion, each emotion triggers a discrete pattern of behaviour, physiology, thoughts and feelings (Mauss \& Robinson, 2009; Russell, 2003). This research will assess adolescents' emotion regulation through three dimensions: a) self-reported emotion reactivity (e.g. sensitivity, arousal/intensity and persistence), b) self-reported emotion regulation (e.g. self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance, planning, impulsivity, awareness and emotional clarity) and c) physiological (heart rate and skin conductance). These three dimensions will be assessed before and after the prevention program using relevant questionnaires and an experiment. The prevention program will focus on the enhancement of emotion regulation. However, it is expected that differences in the other two dimensions will also be found parallel to enhancement of emotion regulation skills.
Regarding the randomized control trial study, half of participants will take part in the intervention group and the other half in the waiting-list group. Participants will be divided into groups; each group of 5-10 adolescents (mixed male and female). Participants in the waiting-list group will receive the intervention when the intervention group finish the intervention. The questionnaires will be answered by all participants before and after the intervention and by those in the waiting list group. All participants will answer the questionnaires before and after a five week time interval during which the intervention will take place for the intervention group.
Physiological assessment of emotion processing will be of a 5 minutes duration, during an emotional imagery task, and participants participate twice -before and after the intervention for the intervention group, and two times with 5 weeks in between for the waiting-list group. The experiment will begin after a rest period which includes relaxation in the absence of any stimuli for 2 minutes (baseline) during which heart rate (HR) and skin conductance (SC) will be measured. Afterwards, participants will be asked to imagine six pre-standardized emotional scenarios, which three of them focusing on anger and three on fear situations, appropriate for their age. Participants will be given specific instructions on how to regulate their emotional responses to each scenario. Participants are given written instructions as to how they are to regulate elicited emotions during the different scenarios. Three different sets of emotion regulation instructions will be given to all participants: no guidance, acceptance and cognitive reappraisal. Participants will memorize each scenario prior to engaging in imagery and have to recall the scene as vividly as possible when each trial begins as prompted by the researcher. The duration of each imagery trial for each scenario is 30 seconds. Physiological measurements will be recorded during each scenario. More specifically, heart rate and skin conductance will be measured. Once this pre-intervention assessment is completed, the 7 sessions of group intervention will follow. In addition, at the end of each session participants will set a goal relevant to the skills which they have just learnt to practice at home as homework. For example, if the content of the session is the anger management, participants goal will be to start recognize their emotions and try to calm using different ways, and then when they are ready to express their emotions and try to find a functional solution.
- Conditions
- Emotional Problem, Behavior Problem
- Being tested
- Enhancement of emotion regulation skills
- Keywords
- Emotion regulation, Prevention program, Adolescents, Physiological measurements, Internalizing problems, Externalizing problems
- Medical subject headings
- Mental Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancement of emotion regulation skillsBehavioural
Also called Cognitive-behavioral and dialectical-behavioral therapy
Regarding the intervention, 7 sessions will be carried out. The main purpose is to help adolescents to enhance their emotion regulation, with the ultimate goal to decrease their risk of developing addictions and other psychopathology.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention group will take part in the sessions of the intervention, in which they learn different skills for the purpose of emotion regulation. All participants will complete the questionnaires and take part in the experiment again. This group prevention program, which is short-term, entailing 7 sessions, synthesizes techniques from three therapeutic models: Cognitive-Behavioral Therapy, Dialectical-Behavioral Therapy and Acceptance and Commitment Therapy. Receives: Behavioral: Enhancement of emotion regulation skills |
| Waiting-list group | No intervention | The waiting-list group will receive the intervention 7 weeks after the intervention group finishes. The intervention group will finish the research in week 7, while the waiting-list group will start to attend the intervention. They will complete the questionnaires and the experiment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in difficulties of emotion regulation
Self-reported measures for adolescents' emotion regulation skills: Difficulties in Emotion Regulation Scale (Gratz \& Roemer, 2004). It is a brief, 36-item self-report questionnaire designed to assess multiple aspects of emotional dysregulation. Each item is rated on a 1 to 5 scale (1 =almost never and 4 = almost always). Higher scores suggest greater problems with emotion regulation. This questionnaire assesses six sub-scales: acceptance, goals, impulsivity, awareness, strategies and clarity.
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Changes in enhancement of emotion regulation skills
Self-reported measures for adolescents' emotion regulation: Cognitive Emotion Regulation Questionnaire (Garnefski, Kraaij, \& Spinhoven, 2002). It is a 36-item questionnaire, consisting of 9 conceptually distinct subscales (Self-blame, Other-blame, Rumination, Catastrophizing, Putting into Perspective, Positive Refocusing, Positive Reappraisal, Acceptance and Planning). Each item is rated on a 1 to 5 scale (1 =almost never and 4 = almost always). Individual subscale scores are obtained by summing up the scores belonging to the particular subscale (ranging from 4 to 20). The higher the subscale score, the more a specific cognitive strategy is used.
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Changes in heart rate
Experiment: measured through heart rate
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Psychophysiological changes in skin conductance
Experiment: measured through skin conductance
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Secondary outcomes (6)
Depression symptoms
Changes in the self-reported measure Youth Self-Report sub-scores of depression symptoms. This screening tool contains 13 questions to assess the depression symptoms, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater emotional problems.
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Anxiety symptoms
Changes in the self-reported measure Youth Self-Report sub-scores of anxiety symptoms. This screening tool contains 6 questions to assess the anxiety symptoms, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater anxiety problems.
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Aggression problems
Changes in the self-reported measure Youth Self-Report sub-scores of conduct disorder. This tool contains 15 questions to assess the conduct disorder, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater conduct problems.
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Attention-Deficit/Hyperactivity Disorder symptoms
Changes in the self-reported measure Youth Self-Report sub-scores of attention deficit/ hyperactivity disorder. This tool contains 7 questions to assess the attention deficit/ hyperactivity disorder, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater problems with attention deficit/ hyperactivity disorder.
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Change in Nicotine Dependence
Change in the Fagerstrom Test of Nicotine Dependence averaged scores. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use and dependence. Higher scores suggest nicotine dependence.
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Change in alcohol consumption
Change in the Alcohol Use Disorders Identification Test averaged scores
Measured: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Nov 2018
- Primary completion15 May 2020 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Emotional ProblemStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiana Theodorou, University of Cyprus
- Investigators
- Christiana Theodorou, MSc., Principal investigator, University of CyprusGeorgia Panayiotou, Ph.D., Study director, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001140
- Sponsor's protocol ID
- UCyprus
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldin PR, Moodie CA, Gross JJ. Acceptance versus reappraisal: Behavioral, autonomic, and neural effects. Cogn Affect Behav Neurosci. 2019 Aug;19(4):927-944. doi: 10.3758/s13415-019-00690-7.
PubMed 30656602Milyavsky M, Webber D, Fernandez JR, Kruglanski AW, Goldenberg A, Suri G, Gross JJ. To reappraise or not to reappraise? Emotion regulation choice and cognitive energetics. Emotion. 2019 Sep;19(6):964-981. doi: 10.1037/emo0000498. Epub 2018 Sep 20.
PubMed 30234328Smith EN, Romero C, Donovan B, Herter R, Paunesku D, Cohen GL, Dweck CS, Gross JJ. Emotion theories and adolescent well-being: Results of an online intervention. Emotion. 2018 Sep;18(6):781-788. doi: 10.1037/emo0000379. Epub 2017 Dec 21.
PubMed 29265838Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.
PubMed 12212647Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
PubMed 16300724Sloan DM, Kring AM. Measuring changes in emotion during psychotherapy: conceptual and methodological issues. Clinical Psychology: Science and Practice 14: 307-322, 2007.
Southam-Gerow MA. Emotion regulation in children and adolescents. New York: the Guilford Press, 2013.
Gratz KL, Roemer L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26: 41-54, 2004.
Thompson RJ, Dizen M, Berenbaum H. The Unique Relations between Emotional Awareness and Facets of Affective Instability. J Res Pers. 2009 Oct 1;43(5):875-879. doi: 10.1016/j.jrp.2009.07.006.
PubMed 20190861Feldman-Barrett L, Gross JJ, Christensen TC, Benvenuto M. Knowing what you're feeling and knowing what to do about it: mapping the relation between emotion differentiation and emotion regulation. Cognition and Emotion 15: 713-724, 2001.
Marchesi C, Fonto S, Balista C, Cimmino C, Maggini C. Relationship between alexithymia and panic disorder: a longitudinal study to answer an open question. Psychother Psychosom. 2005;74(1):56-60. doi: 10.1159/000082028.
PubMed 15627858Leahy RL. A model of emotional schemas. Cognitive and Behavioral Practice 9: 177-190, 2002.
Salovey P, Mayer JD, Goldman SL, Turvey C, Palfai TP. Emotional attention, clarity, and repair: exploring emotional intelligence using the trait meta-mood scale. In JW Pennebaker (Ed.), Emotion, disclosure, and health (pp. 125-154). Washington, DC: American Psychological Association, 1995.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Emotion Regulation Skills in Vulnerable Adolescents at Risk for Addictions and Psychopathology Due to Risk Factors in the Family
- ClinicalTrials.gov ID
- NCT04001140
- Acronym / sponsor ID
- UCyprus
- Conditions
- Emotional Problem, Behavior Problem
- Keywords
- Emotion regulation, Prevention program, Adolescents, Physiological measurements, Internalizing problems, Externalizing problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 27 Jun 2019 (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.
For the current study, a prevention program is developed and applied to enhance the emotion regulation skills of adolescents. Before and after the application of the prevention program, all participants will be assessed for their emotion regulation ability via questionnaires and a physiological examination in which heart rate and skin conductance will be measured.
Detailed description
The purpose of this research is to assess whether a short-term group intervention can enhance the emotion regulation skills of adolescents, when the family environment experiences stressful situations, psychopathology or substance abuse. This study aims to increase intervention effectiveness by examining effective approaches to train a crucial mechanism involved in emotional and behavior problems, which is emotion regulation. This research aims to develop a prevention program focused on the enhancement of adolescents' emotion regulation. Before and after the prevention program, participants will answer questionnaires and do a 5 minute psychophysiology experiment to evaluate their emotion regulation ability with both subjective and objective approaches. This prevention program, which is short-term, entailing 7 sessions, synthesizes techniques from three therapeutic models: Cognitive-Behavioral Therapy, Dialectical-Behavioral Therapy and Acceptance and Commitment Therapy. A short-term intervention was formulated and will be tested in the current study, with which is considered an advancement from previous similar interventions because of this synthesis and specific focus on emotion regulation skills, the lack of which can be considered a transdiagnostic risk factor across many psychological conditions and outcomes, including substance use. The main purpose is to help adolescents to enhance their emotion regulation, with the ultimate goal to decrease their risk of developing addictions and other psychopathology.
According to some classic theories of emotion, each emotion triggers a discrete pattern of behaviour, physiology, thoughts and feelings (Mauss \& Robinson, 2009; Russell, 2003). This research will assess adolescents' emotion regulation through three dimensions: a) self-reported emotion reactivity (e.g. sensitivity, arousal/intensity and persistence), b) self-reported emotion regulation (e.g. self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance, planning, impulsivity, awareness and emotional clarity) and c) physiological (heart rate and skin conductance). These three dimensions will be assessed before and after the prevention program using relevant questionnaires and an experiment. The prevention program will focus on the enhancement of emotion regulation. However, it is expected that differences in the other two dimensions will also be found parallel to enhancement of emotion regulation skills.
Regarding the randomized control trial study, half of participants will take part in the intervention group and the other half in the waiting-list group. Participants will be divided into groups; each group of 5-10 adolescents (mixed male and female). Participants in the waiting-list group will receive the intervention when the intervention group finish the intervention. The questionnaires will be answered by all participants before and after the intervention and by those in the waiting list group. All participants will answer the questionnaires before and after a five week time interval during which the intervention will take place for the intervention group.
Physiological assessment of emotion processing will be of a 5 minutes duration, during an emotional imagery task, and participants participate twice -before and after the intervention for the intervention group, and two times with 5 weeks in between for the waiting-list group. The experiment will begin after a rest period which includes relaxation in the absence of any stimuli for 2 minutes (baseline) during which heart rate (HR) and skin conductance (SC) will be measured. Afterwards, participants will be asked to imagine six pre-standardized emotional scenarios, which three of them focusing on anger and three on fear situations, appropriate for their age. Participants will be given specific instructions on how to regulate their emotional responses to each scenario. Participants are given written instructions as to how they are to regulate elicited emotions during the different scenarios. Three different sets of emotion regulation instructions will be given to all participants: no guidance, acceptance and cognitive reappraisal. Participants will memorize each scenario prior to engaging in imagery and have to recall the scene as vividly as possible when each trial begins as prompted by the researcher. The duration of each imagery trial for each scenario is 30 seconds. Physiological measurements will be recorded during each scenario. More specifically, heart rate and skin conductance will be measured. Once this pre-intervention assessment is completed, the 7 sessions of group intervention will follow. In addition, at the end of each session participants will set a goal relevant to the skills which they have just learnt to practice at home as homework. For example, if the content of the session is the anger management, participants goal will be to start recognize their emotions and try to calm using different ways, and then when they are ready to express their emotions and try to find a functional solution.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Enhancement of emotion regulation skillsThe intervention group will take part in the sessions of the intervention, in which they learn different skills for the purpose of emotion regulation. All participants will complete the questionnaires and take part in the experiment again. This group prevention program, which is short-term, entailing 7 sessions, synthesizes techniques from three therapeutic models: Cognitive-Behavioral Therapy, Dialectical-Behavioral Therapy and Acceptance and Commitment Therapy. |
| Waiting-list group | No intervention | –The waiting-list group will receive the intervention 7 weeks after the intervention group finishes. The intervention group will finish the research in week 7, while the waiting-list group will start to attend the intervention. They will complete the questionnaires and the experiment. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents who have a family member with addiction problems (drug or alcohol use, gambling)
- Adolescents who have a family member with psychological problems (e.g. depression, anxiety disorder, bipolar disorder, etc.)
- Adolescents from stressful family environments (domestic violence, maltreatment, divorce, mourning, etc.)
- Participants are literate in Greek.
Key exclusion criteria (3 listed)
- Adolescents with severe addiction problems themselves (daily or weekly drugs use, such as cocaine, heroin, crystal meth, etc.)
- Adolescents with severe psychopathology (e.g. bipolar disorder, schizophrenia)
- Participants who are not literate in Greek.
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 |
|---|---|---|
| Enhancement of emotion regulation skillsAlso: Cognitive-behavioral and dialectical-behavioral therapyRegarding the intervention, 7 sessions will be carried out. The main purpose is to help adolescents to enhance their emotion regulation, with the ultimate goal to decrease their risk of developing addictions and other psychopathology. | Behavioural | Intervention group |
Primary outcome
Changes in difficulties of emotion regulation
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Self-reported measures for adolescents' emotion regulation skills: Difficulties in Emotion Regulation Scale (Gratz \& Roemer, 2004). It is a brief, 36-item self-report questionnaire designed to assess multiple aspects of emotional dysregulation. Each item is rated on a 1 to 5 scale (1 =almost never and 4 = almost always). Higher scores suggest greater problems with emotion regulation. This questionnaire assesses six sub-scales: acceptance, goals, impulsivity, awareness, strategies and clarity.
Changes in enhancement of emotion regulation skills
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Self-reported measures for adolescents' emotion regulation: Cognitive Emotion Regulation Questionnaire (Garnefski, Kraaij, \& Spinhoven, 2002). It is a 36-item questionnaire, consisting of 9 conceptually distinct subscales (Self-blame, Other-blame, Rumination, Catastrophizing, Putting into Perspective, Positive Refocusing, Positive Reappraisal, Acceptance and Planning). Each item is rated on a 1 to 5 scale (1 =almost never and 4 = almost always). Individual subscale scores are obtained by summing up the scores belonging to the particular subscale (ranging from 4 to 20). The higher the subscale score, the more a specific cognitive strategy is used.
Changes in heart rate
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Experiment: measured through heart rate
Psychophysiological changes in skin conductance
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Experiment: measured through skin conductance
6 secondary outcomes
Depression symptoms
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Anxiety symptoms
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Aggression problems
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Attention-Deficit/Hyperactivity Disorder symptoms
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Change in Nicotine Dependence
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Change in alcohol consumption
Time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Background: PubMed 30656602Goldin PR, Moodie CA, Gross JJ. Acceptance versus reappraisal: Behavioral, autonomic, and neural effects. Cogn Affect Behav Neurosci. 2019 Aug;19(4):927-944. doi: 10.3758/s13415-019-00690-7.
- Background: PubMed 30234328Milyavsky M, Webber D, Fernandez JR, Kruglanski AW, Goldenberg A, Suri G, Gross JJ. To reappraise or not to reappraise? Emotion regulation choice and cognitive energetics. Emotion. 2019 Sep;19(6):964-981. doi: 10.1037/emo0000498. Epub 2018 Sep 20.
- Background: PubMed 29265838Smith EN, Romero C, Donovan B, Herter R, Paunesku D, Cohen GL, Dweck CS, Gross JJ. Emotion theories and adolescent well-being: Results of an online intervention. Emotion. 2018 Sep;18(6):781-788. doi: 10.1037/emo0000379. Epub 2017 Dec 21.
- Background: PubMed 12212647Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.
- Background: PubMed 16300724Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
- BackgroundSloan DM, Kring AM. Measuring changes in emotion during psychotherapy: conceptual and methodological issues. Clinical Psychology: Science and Practice 14: 307-322, 2007.
- BackgroundSoutham-Gerow MA. Emotion regulation in children and adolescents. New York: the Guilford Press, 2013.
- BackgroundGratz KL, Roemer L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26: 41-54, 2004.
- Background: PubMed 20190861Thompson RJ, Dizen M, Berenbaum H. The Unique Relations between Emotional Awareness and Facets of Affective Instability. J Res Pers. 2009 Oct 1;43(5):875-879. doi: 10.1016/j.jrp.2009.07.006.
- BackgroundFeldman-Barrett L, Gross JJ, Christensen TC, Benvenuto M. Knowing what you're feeling and knowing what to do about it: mapping the relation between emotion differentiation and emotion regulation. Cognition and Emotion 15: 713-724, 2001.
- Background: PubMed 15627858Marchesi C, Fonto S, Balista C, Cimmino C, Maggini C. Relationship between alexithymia and panic disorder: a longitudinal study to answer an open question. Psychother Psychosom. 2005;74(1):56-60. doi: 10.1159/000082028.
- BackgroundLeahy RL. A model of emotional schemas. Cognitive and Behavioral Practice 9: 177-190, 2002.
- Individual participant dataSharing planned: No
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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.
Christiana Theodorou, MSc. principal investigator
University of Cyprus
Georgia Panayiotou, Ph.D. study director
University of Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancement of emotion regulation skills in people with Emotional Problem and Behavior Problem, run by University of Cyprus at 1 site in Cyprus.
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 4 inclusion and 3 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 9 Apr 2020. 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 Cyprus. 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?
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?
Changes in difficulties of emotion regulation (time frame: Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)). 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?
On the ClinicalTrials.gov record for NCT04001140, which also lists 13 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 9 Apr 2020.