NCT04001140

Brief 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 heart rate and skin conductance will be measured.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

April 9, 2020

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

June 14, 2019

Last Update Submit

April 7, 2020

Conditions

Keywords

Emotion regulationPrevention programAdolescentsPhysiological measurementsInternalizing problemsExternalizing problems

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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

    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

    Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)

  • Anxiety symptoms

    Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)

  • Aggression problems

    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

    Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)

  • Change in Nicotine Dependence

    Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Cognitive-behavioral and dialectical-behavioral therapy
Intervention group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cyprus

Nicosia, 2109, Cyprus

Location

Related Publications (13)

  • 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.

    PMID: 30656602BACKGROUND
  • Milyavsky 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.

    PMID: 30234328BACKGROUND
  • Smith 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.

    PMID: 29265838BACKGROUND
  • Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.

    PMID: 12212647BACKGROUND
  • Hayes 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.

    PMID: 16300724BACKGROUND
  • Sloan DM, Kring AM. Measuring changes in emotion during psychotherapy: conceptual and methodological issues. Clinical Psychology: Science and Practice 14: 307-322, 2007.

    BACKGROUND
  • Southam-Gerow MA. Emotion regulation in children and adolescents. New York: the Guilford Press, 2013.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20190861BACKGROUND
  • Feldman-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
  • 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.

    PMID: 15627858BACKGROUND
  • Leahy RL. A model of emotional schemas. Cognitive and Behavioral Practice 9: 177-190, 2002.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Christiana Theodorou, MSc.

    University of Cyprus

    PRINCIPAL INVESTIGATOR
  • Georgia Panayiotou, Ph.D.

    University of Cyprus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 27, 2019

Study Start

November 1, 2018

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

April 9, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations