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Completed

NCT Number: NCT03858296

Trial of Emotion Regulation for Inappropriate Anger Expression

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 expression-out, anger expression-out, anger control-in, and trait anger; 3. whether the treatment effects are mediated by changes in emotional awareness, cognitive reappraisal, and anger control-in.

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Key information

Conditions

Inappropriate Anger Expression

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

Stockholm, 113 64, Sweden

About this study

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet-delivered emotional awareness training

Behavioral

Emotional awareness training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.

Internet-delivered Cognitive reappraisal training

Behavioral

Cognitive reappraisal training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.

Internet-delivered awareness and reappraisal training

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Randomized Controlled Trial of Emotion Regulation for Inappropriate Anger Expression

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2019
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.