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Maladaptive Anger InhibitioneCREATNCT06697587

Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT) for Maladaptive Anger Inhibition - A Pilot Study

A study testing Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT) in people with Maladaptive Anger Inhibition, run by Örebro University, Sweden at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Habitual suppression of intense anger, commonly known as maladaptive anger inhibition, is a widespread issue related to various adverse outcomes. These include, for instance, diminished social support, reduced relationship quality, increased risk for coronary heart disease, and heightened susceptibility to chronic and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Maladaptive Anger Inhibition
What is being tested?
Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSweden
Study dates
17 Jan 2024to 13 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Experience of maladaptive anger inhibition as indicated by a score on the upper quartile on the Anger Expression-In scale from State-Trait Anger Expression Inventory-2 (STAXI-2).

Who cannot join

  • Risk for violence and harm to others.
  • Prior convictions of violence/abuse.
  • Ongoing psychological treatment.
  • Change in psychotropic medication within 2 months prior to enrollment.
  • Severe psychiatric disorder, such as severe depression or psychotic disorder
  • Ongoing substance use.
Show all 9Show fewer
  • Life circumstances that interfere with treatment.
  • Suicidal ideation.
  • Not able to read and write in Swedish or learning difficulties (the treatment-format requires normal literacy skills).

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Örebro University

    Örebro

Other trials in Sweden

About this study

Habitual suppression of intense anger, commonly known as maladaptive anger inhibition, is a widespread issue related to various adverse outcomes. These include, for instance, diminished social support, reduced relationship quality, increased risk for coronary heart disease, and heightened susceptibility to chronic and temporary pain conditions. Developing effective psychological treatments may be one key approach to alleviate the distress experienced amongst these individuals.

The overall goal of this pilot study is to further develop and enhance a previously evaluated treatment protocol for maladaptive anger (Bjureberg et al., 2023) to more effectively target maladaptive anger inhibition. The specific goals are:

  1. To assess the feasibility and acceptability of the study (operationalized as number of completed modules and measurements, reported negative events and patient experience).
  2. To assess outcome variability and estimate the relative effect of the treatment in reducing maladaptive anger inhibition. Maladaptive anger inhibition was operationalized as high levels of trait anger suppression (main outcome), anger rumination (secondary outcome) as well as low levels assertive expression of anger (secondary outcome). Secondary aims (to be reported in secondary papers)
  3. To assess and explore participants' qualitative experiences of maladaptive anger inhibition.
  4. To explore within-subjects emotion dynamics using daily assessments.
Read the detailed description
  1. Treatment feasibility and acceptability will be assessed by measuring treatment retention and adherence (operationalized as number of drop-outs, completed modules, homework assignments, and assessments), treatment credibility and satisfaction (using questionnaires), number of reported adverse events and patient experiences following treatment (see below for details).
  2. Following the intention to treat principle data will be analyzed using all participants that were included in the treatment. Preliminary treatment efficacy will be determined by assessing the phase effect of the treatment for each respective outcome (trait anger suppression, anger rumination, and anger assertiveness). More specifically, an interrupted time series design will be used to compare the difference in effect between the treatment phase and a prolonged baseline phase, each consisting of 4 assessments (totaling 8 measurement points). The primary phase effects will be evaluated at treatment termination. Moreover, we will also explore whether treatment effects are maintained at the 3-month follow-up.
  3. A subset of 10 consenting participants will be invited to post-treatment interviews. Participants will chosen so as to ensure representation across demographic and clinical variables such as age, gender, and whether they improved or not on the main outcome (trait anger suppression). Interviews will both focus on treatment experiences (goal 1) and participants' qualitative experiences of maladaptive anger inhibition (goal 3).
  4. Participants will complete two bursts of 7 days of daily measures of anger and anger regulation strategies, one burst before treatment and one after). These daily measurements will be used to explore within-subject emotion dynamics by comparing emotion dynamics before and after the treatment using dynamic structural equation modeling (DSEM) as our analytical method.

Assessment procedure:

Participants will undergo intensive assessment throughout the project. Participants will complete 1 screening assessment followed by 4 weeks of weekly baseline assessments, with one of the weeks including daily assessments (burst 1). Following the baseline phase, participants will enroll in a 4-week online treatment with weekly assessments. After treatment, participants will undergo 1 week of daily assessments (burst 2) and a 3-month follow-up.

Being tested
Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT)Behavioural

    eCREAT features psychoeducational content on anger management, practical exercises, and homework assignments, all supported by an online therapist who provides text-based feedback. The protocol builds on a previously evaluated protocol for maladaptive anger (ClinicalTrials.gov; ID: NCT03858296) with added focus on anger inhibition.

    eCREAT is based on the two-stage model of maladaptive anger inhibition (Burns et al., 2008), which posits that suppressed anger may rebound and return as angry fantasies and ruminations. To address these core mechanisms, the treatment includes training on adaptive anger processing and expression and strategies for disrupting anger ruminations. These added treatment components are based on established protocols for depressive rumination, and assertive expression of emotion, adapted for an anger context. Additionally, the treatment also focuses on how to flexibly shift between different emotion regulation strategies depending on contextual demands.

Study groups in NCT06697587
Study groupRoleWhat they receive
eCREATExperimentaleCREAT consists of four guided internet modules delivered over four weeks (one each week), see "intervention description" below for further details.
Receives: Behavioral: Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. State-Trait Anger Expression Inventory-2, Anger-Expression In scale (STAXI-2; AX-I)

    Used to assess symptom severity of maladaptive anger inhibition. The AX-I scale has 8 items, each rated on a 4 point, with higher scores reflecting higher degree of anger inhibition. Self-rated.

    Measured: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.

Secondary outcomes (13)
  1. Behavioral Anger Response Questionnaire, Assertion scale (BARQ; assertion)

    Used to assess the level of assertive expression of anger. The assertion scale has 6 items, each rated on a 5-point scale, with higher scores indicating greater anger assertion. Self-rated.

    Measured: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.

  2. Anger Rumination Scale (ARS)

    Used to assess levels anger rumination. The scale has 19 items, each rated on a 4-point scale, with higher scores indicating greater levels of anger rumination. Self-rated.

    Measured: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.

  3. Self-Critical Rumination Scale (SCRS)

    Used to assess levels of self-critical rumination. The scale has 10 items, each rated on a 4-point scale, with higher scores indicating greater levels of self-critical rumination. Self-rated.

    Measured: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.

  4. Thought Suppression Inventory - Revised, Suppression attempts scale (TSI; Suppression attempts)

    Used to assess levels of thought suppression, adapted for measuring suppression of angry thoughts. The suppression attempts scale has 7 items, each rated on a 5-point scale, with higher scores indicating greater levels of attempts to suppress angry thoughts. Self-rated.

    Measured: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.

  5. Emotion Regulation Questionnaire (ERQ)

    Used to assess the degree of usage of cognitive reappraisal and expressive suppression, as two emotion regulation strategies. ERQ consists of 10 items divided on two scales that measure cognitive reappraisal (6 items) and expressive suppression (4 items) respectively. Each item is rated on a 7-point scale, with higher scores indicating greater usage of either cognitive reappraisal or expressive suppression. Self-rated.

    Measured: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.

  6. Five Facets Mindfulness Questionnaire (FFMQ)

    Used to assess the degree of usage of different facets of mindfulness to regulate emotions. FFMQ consists of 29 items and the following scales, each measuring different facets of mindfulness: Observing, Describing, Acting with Awareness, Nonjudging, and Nonreactivity. Each item is rated on a 5-point scale, with higher scores reflecting greater usage of that specific mindfulness facet. Self-rated.

    Additional info about time frame: In this study the Describing and Nonjudging scales were assessed at each assessment point whereas the Acting with Awareness, and Nonreactivity scales were only assessed at screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up. The observing scale was not included in this study.

    Measured: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up (see description for details).

  7. Aggression Questionnaire (AQ)

    Used to assess level of aggression. AQ consists of 29 items and the following scales: verbal aggression, physical aggression, hostility and anger. For this study we only used the verbal aggression, physical aggression, and hostility scales. Each item is rated on a 4-point scale, with higher score reflecting greater levels of aggression. Self-rated.

    Measured: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.

  8. Indirect Aggression Scale for perpetrators (IAS-A)

    Used to assess three dimensions of passive aggression. IAS-A consists of 25 items and the following scales: social exclusion, malicious humor and guilt induction. Each item is rated on a 5-point scale, with higher scores representing greater use of passively aggressive behavior. Self-rated.

    Measured: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.

  9. Perth Alexithymia Questionnaire-Short Form (PAQ-S)

    Used to assess difficulties with identifying and describing emotional experiences (i.e., Alexithymia). PAQ-S consists of 6 items, each item israted on a 7-point scale, with higher scores representing greater problems with Alexithymia. Self-rated.

    Measured: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.

  10. Difficulties with Emotion Regulation Scale-16 (DERS-16)

    Used to assess difficulties with regulating emotions. DERS consists of 16 items and the following scales: clarity, goals, impulse, emotion regulation, and nonacceptance. Each item is rated on a 5-point scale, with higher scores representing greater difficulties with regulating emotions. Self-rated.

    Measured: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up

  11. Symptom Scale-8 (SSS-8)

    Used to assess somatic symptoms and pain burden. SSS-8 consist of 8 items, each item is rated on a 5-point scale, with higher scores representing greater degree of pain problems. Self-rated.

    Measured: Screening, treatment week 4 (post), and at the 3-month follow-up.

  12. Affective Control Scale, fear of anger subscale (ACS)

    Used to assess fear of anger. The fear of anger scale consists of 8 items, each rated on a 7-point scale, with higher scores indicating greater fear of anger.

    Measured: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.

  13. State-Trait Anger Expression Inventory-2, Anger-Expression Out scale, and trait anger (STAXI-2; AX-O;T-ANG)

    Used to assess symptom severity of maladaptive expressions of anger and frequency of anger experiences (i.e., trait anger). The anger-expression out scale consists of 8 items, each rated on a 4-point scale with higher scores indicating greater problems with anger expression. The trait anger scale consists of 10 items, each rated on a 4-points scale, with higher scores indicating greater frequency of anger experiences. Self-rated.

    Measured: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start17 Jan 2024
  3. Primary completion13 Aug 2024
  4. Study completion13 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697587
Sponsor's protocol ID
20230417601
Acronym
eCREAT
Status last verified
Jan 2025
First submitted
18 Nov 2024
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) cannot be publicly available according to national (Swedish) and European Union legislation and thus cannot be published in an open repository. However, if granted by the ethical review board in Stockholm, Sweden, aggregated data could be made available upon request.

Publications

  • 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.

    PubMed 36409100
  • Burns JW, Quartana PJ, Bruehl S. Anger inhibition and pain: conceptualizations, evidence and new directions. J Behav Med. 2008 Jun;31(3):259-79. doi: 10.1007/s10865-008-9154-7. Epub 2008 May 23.

    PubMed 18498056
  • Larsson J, Ojala O, Bjureberg J, Sederstrom P, Hvass O, Bjork P, Lidskog S, Hesser H. Online emotion regulation treatment for maladaptive anger inhibition - an open-label pilot with a pooled interrupted time series design. Cogn Behav Ther. 2025 Aug 4:1-16. doi: 10.1080/16506073.2025.2542355. Online ahead of print.

    PubMed 40757961

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT) in people with Maladaptive Anger Inhibition, run by Örebro University, Sweden at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State-Trait Anger Expression Inventory-2, Anger-Expression In scale (STAXI-2; AX-I) (time frame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06697587, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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