Clinical trial NCT06697587: Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT) for Maladaptive Anger Inhibition - A Pilot Study
Official title: Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT) for Maladaptive Anger Inhibition - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maladaptive Anger Inhibition
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2024-11-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* 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).

Primary outcomes:
measure: State-Trait Anger Expression Inventory-2, Anger-Expression In scale (STAXI-2; AX-I)
timeFrame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.
Secondary outcomes:
measure: Behavioral Anger Response Questionnaire, Assertion scale (BARQ; assertion)
timeFrame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.
measure: Anger Rumination Scale (ARS)
timeFrame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.
measure: Self-Critical Rumination Scale (SCRS)
timeFrame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.
measure: Thought Suppression Inventory - Revised, Suppression attempts scale (TSI; Suppression attempts)
timeFrame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.
measure: Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up (see description for details).
measure: Aggression Questionnaire (AQ)
timeFrame: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.
measure: Indirect Aggression Scale for perpetrators (IAS-A)
timeFrame: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.
measure: Perth Alexithymia Questionnaire-Short Form (PAQ-S)
timeFrame: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.
measure: Difficulties with Emotion Regulation Scale-16 (DERS-16)
timeFrame: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up
measure: Symptom Scale-8 (SSS-8)
timeFrame: Screening, treatment week 4 (post), and at the 3-month follow-up.
measure: Affective Control Scale, fear of anger subscale (ACS)
timeFrame: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.
measure: State-Trait Anger Expression Inventory-2, Anger-Expression Out scale, and trait anger (STAXI-2; AX-O;T-ANG)
timeFrame: Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.
Other outcomes:
measure: Demographic information
timeFrame: Screening
measure: Mini International Neuropsychiatric Interview (MINI
timeFrame: Screening
measure: Risk for Violence Interview (RVI)
timeFrame: Screening
measure: Treatment Credibility Scale (TCS)
timeFrame: Treatment week 2
measure: Client Satisfaction Questionnaire -8 (CSQ-8)
timeFrame: Treatment week 4 (post)
measure: Questionnaire on adverse events experienced during internet-therapy
timeFrame: Treatment week 4 (post), and at 3-month follow-up.
measure: Patient adherence
timeFrame: Treatment week 1-4
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Hugo Hesser, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.