NCT03858296

Trial of Emotion Regulation for Inappropriate Anger Expression

Randomized Controlled Trial of Emotion Regulation for Inappropriate Anger Expression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

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.

Conditions

• Inappropriate Anger Expression

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2019-03-05
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2019-02-28
• Last updated: 2021-07-22

Locations

1 site across 1 country: Sweden