Trial of Emotion Regulation for Inappropriate Anger Expression

Inappropriate Anger Expression Clinical Trial

Official title:

Randomized Controlled Trial of Emotion Regulation for Inappropriate Anger Expression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858296
• Other study ID #: 2018/2253-31/5
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: July 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inappropriate Anger Expression

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Credibility Scale	Treatment credibility and expectancy (range: 0-50) with higher scores indicating greater credibility/expectancy.	1 week after treatment starts
Other	Client satisfaction Questionnaire	Levels of client treatment satisfaction (range: 8-32) with higher scores indicating more satisfaction.	4 weeks after treatment starts
Primary	State-Trait Anger Expression Inventory-2 (Subscales: Anger-out, Anger-in)	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.	Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.
Secondary	Emotion Regulation Questionnaire (Subscale: Reappraisal)	Levels of reappraisal from the subscale Reappraisal (range: 6-35, with higher scores indicating more reappraisal).	Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.
Secondary	Five Facets Mindfulness Questionnaire (Subscales: Nonreactivity, Non-judging)	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).	Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.
Secondary	State-Trait Anger Expression Inventory-2 (Subscale: Anger control-in)	Levels of anger control-in (range: 8-32; higher scores indicating more anger control-in).	Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.
Secondary	State-Trait Anger Expression Inventory-2 (Subscales: Trait anger, Anger control-out, State anger)	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).	Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended
Secondary	Aggression Questionnaire	Levels of aggression (range 0-87). Higher scores indicate more aggression.	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.
Secondary	Anger Rumination Scale	Levels of anger rumination (range: 19-76). Higher scores indicate more anger rumination.	Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended
Secondary	Five Facets Mindfulness Questionnaire	Levels of mindfulness (range: 29-145). Higher scores indicate more mindfulness.	Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended
Secondary	Emotion Regulation Questionnaire (Subscale Suppression)	Levels of suppression (range: 1-28). Higher scores indicate more suppression.	Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.
Secondary	The Pittsburgh Sleep Quality Index	Sleep quality (range: 0-21). Higher scores indicate worse sleep quality.	Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended
Secondary	Perceived Stress Scale 10 item version	Stress (range: 0-40). Higher scores indicate more negative stress.	Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.