Trial of Emotion Regulation for Inappropriate Anger Expression

NCT ID: NCT03858296

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2020-03-16

Brief Summary

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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

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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

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Inappropriate Anger Expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Emotional awareness

4 modules of emotional awareness training

Group Type EXPERIMENTAL

Internet-delivered emotional awareness training

Intervention Type BEHAVIORAL

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

Cognitive reappraisal

4 modules cognitive reappraisal training

Group Type EXPERIMENTAL

Internet-delivered Cognitive reappraisal training

Intervention Type BEHAVIORAL

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

Awareness + reappraisal

4 modules emotional awareness and cognitive reappraisal training

Group Type EXPERIMENTAL

Internet-delivered awareness and reappraisal training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Johan Bjureberg

Licenced Psychologist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan Bjureberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Centre for Psychiatry Research Karolinska Institutet and Stockholm County Council

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Bjureberg J, Ojala O, Berg A, Edvardsson E, Kolbeinsson O, Molander O, Morin E, Nordgren L, Palme K, Sarnholm J, Wedin L, Ruck C, Gross JJ, Hesser H. Targeting maladaptive anger with brief therapist-supported internet-delivered emotion regulation treatments: A randomized controlled trial. J Consult Clin Psychol. 2023 May;91(5):254-266. doi: 10.1037/ccp0000769. Epub 2022 Nov 21.

Reference Type DERIVED
PMID: 36409100 (View on PubMed)

Other Identifiers

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2018/2253-31/5

Identifier Type: -

Identifier Source: org_study_id

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