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Trial of Emotion Regulation for Inappropriate Anger Expression

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ClinicalTrials.gov Identifier: NCT03858296
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Johan Bjureberg, Karolinska Institutet

Brief Summary:

The overall aim of the project is to develop three internet-delivered cognitive behavior therapies for inappropriate anger expression to test the isolated and combined effects of two types of regulation strategies, emotional awareness and cognitive reappraisal. Treatments will be evaluated in a stratified single blind parallel randomized block design, along with a pooled interrupted time series design. Self-recruited adults with elevated levels of anger will be stratified based on baseline level of anger. The particular aims are to examine:

  1. the overall and separate effects of emotional awareness training, cognitive reappraisal training, and emotional awareness and cognitive reappraisal training on anger and aggression;
  2. whether treatment effects are differentially moderated by baseline levels of emotional awareness, cognitive reappraisal, anger control-in, and trait anger;
  3. whether the treatment effects are mediated by changes in emotional awareness, cognitive reappraisal, and anger control-in.

Condition or disease Intervention/treatment Phase
Inappropriate Anger Expression Behavioral: Internet-delivered emotional awareness training Behavioral: Internet-delivered Cognitive reappraisal training Behavioral: Internet-delivered awareness and reappraisal training Not Applicable

Detailed Description:
  1. Following the intention-to-treat principle, all primary data models will include all individuals as randomized. 3-month follow-up will be considered as the primary end-point. We will analyze both (1) overall treatment effect of all treatments (active treatment phase and 3-month follow-up compared to baseline) and (2) the relative efficacy for the emotional awareness training, cognitive reappraisal training, and emotional awareness and cognitive reappraisal training, respectively. We expect that, compared to a prolonged baseline phase, all treatments will result in greater improvements in on both primary and secondary outcomes. Further, we predict that the combined intervention will produce, on average, the strongest effects on primary and secondary outcomes relative to the separate interventions. We expect that cognitive reappraisal training will result in greater improvements relative to emotional awareness as a standalone treatment.
  2. Growth models that include the interaction terms between experimental conditions (contrast coded) and baseline levels of moderator variables (as continuous measures) will be utilized to examine moderated treatment effects. Significant interactions will be examined following recommendations for probing interactions in growth models.
  3. Weekly measurements of mediators will be analyzed with state-of-the-art methods for longitudinal mediation analysis, and we aim to to examine associations among process and outcome variables both within and between individuals as a function of condition and treatment phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Emotion Regulation for Inappropriate Anger Expression
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Emotional awareness
4 modules of emotional awareness training
Behavioral: Internet-delivered emotional awareness training
Emotional awareness training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.

Experimental: Cognitive reappraisal
4 modules cognitive reappraisal training
Behavioral: Internet-delivered Cognitive reappraisal training
Cognitive reappraisal training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.

Experimental: Awareness + reappraisal
4 modules emotional awareness and cognitive reappraisal training
Behavioral: Internet-delivered awareness and reappraisal training
Emotional awareness and cognitive reappraisal training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.




Primary Outcome Measures :
  1. State-Trait Anger Expression Inventory-2 (Subscales: Anger-out, Anger-in) [ Time Frame: Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended. ]
    Levels of State-trait anger Expression. The subscales Anger Expression-Out (range: 8-32), Anger Expression-In (range: 8-32), and State Anger (range: 15-60) will be used, with higher scores indicating more anger.


Secondary Outcome Measures :
  1. Emotion Regulation Questionnaire (Subscale: Reappraisal) [ Time Frame: Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended. ]
    Levels of reappraisal from the subscale Reappraisal (range: 6-35, with higher scores indicating more reappraisal).

  2. Five Facets Mindfulness Questionnaire (Subscales: Nonreactivity, Non-judging) [ Time Frame: Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended. ]
    Levels of nonreactivity to inner experiences (range: 6-30; with higher scores indicating more nonreactivity) nonjudging of experience (range: 5-25; with higher scores indicating more nonjudging).

  3. State-Trait Anger Expression Inventory-2 (Subscale: Anger control-in) [ Time Frame: Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended. ]
    Levels of anger control-in (range: 8-32; higher scores indicating more anger control-in).

  4. State-Trait Anger Expression Inventory-2 (Subscales: Trait anger, Anger control-out, State anger) [ Time Frame: Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended ]
    Levels of State-Trait Anger Expression. The subscales Trait Anger (range: 10-40; higher scores indicating more trait anger), Anger Control-Out (range: 8-32; higher scores indicating more anger control-out), State Anger (range: 15-60; higher scores indicating more anger control-in).

  5. Aggression Questionnaire [ Time Frame: Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended. Ranges from 0-87, with higher higher scores indicating more aggression problems. ]
    Levels of aggression (range 0-87). Higher scores indicate more aggression.

  6. Anger Rumination Scale [ Time Frame: Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended ]
    Levels of anger rumination (range: 19-76). Higher scores indicate more anger rumination.

  7. Five Facets Mindfulness Questionnaire [ Time Frame: Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended ]
    Levels of mindfulness (range: 29-145). Higher scores indicate more mindfulness.

  8. Emotion Regulation Questionnaire (Subscale Suppression) [ Time Frame: Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended. ]
    Levels of suppression (range: 1-28). Higher scores indicate more suppression.

  9. The Pittsburgh Sleep Quality Index [ Time Frame: Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended ]
    Sleep quality (range: 0-21). Higher scores indicate worse sleep quality.

  10. Perceived Stress Scale 10 item version [ Time Frame: Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended. ]
    Stress (range: 0-40). Higher scores indicate more negative stress.


Other Outcome Measures:
  1. Treatment Credibility Scale [ Time Frame: 1 week after treatment starts ]
    Treatment credibility and expectancy (range: 0-50) with higher scores indicating greater credibility/expectancy.

  2. Client satisfaction Questionnaire [ Time Frame: 4 weeks after treatment starts ]
    Levels of client treatment satisfaction (range: 8-32) with higher scores indicating more satisfaction.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • experience of inappropriate anger expression that leads to significant distress or interferes with daily life (based on the STAXI-II)

Exclusion Criteria:

  • risk for violent behavior that may harm others
  • prior convictions of violence/abuse
  • ongoing psychological treatment that may conflict with the offered treatment
  • change in psychotropic medication within 2 months prior to enrollment
  • severe psychiatric disorder, such as severe depression or risk of suicide
  • alcohol or drug problems
  • life circumstances that interfere with treatment (e.g., homeless)
  • pronounced language skill deficits and learning difficulties (as the treatment format assumes normal reading and writing skills)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858296


Contacts
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Contact: Johan Bjureberg, PhD +46(0)700009188 Johan.Bjureberg@ki.se

Locations
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Sweden
Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council Recruiting
Stockholm, Sweden, 113 64
Contact: Johan Bjureberg, PhD    +46(0)700009188    johan.bjureberg@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Johan Bjureberg, PhD Karolinska Institutet
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Responsible Party: Johan Bjureberg, Licenced Psychologist, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03858296    
Other Study ID Numbers: 2018/2253-31/5
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No