Affect Labeling - Experimental Evaluation and Behavioral Intervention

NCT04826874 | Completed

• 1 other identifier: 2020-06427
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this project is to better understand the emotion regulating effect of labeling emotions (affecting labeling, AL) for individuals with self-perceived emotional regulation difficulties from both a clinical population and a non-clinical population, by using both self-assessment and psychophysiological testing of emotional activation. The main part of the project includes a brief intervention aiming to test the emotion-regulating effect of a short behavioral intervention to learn and practice AL. This two-week intervention, aims to improve the ability to regulate emotions, and to assess the benefits of emotion regulation strategies for individuals with and without a clinical diagnosis, but with self-perceived difficulties in emotion regulation. The second part of this study aims to conceptually replicate a previous basic research study on AL and its emotion-regulating effect in a experimental laboratory setting and to extend that replication to include a clinical group. The replication contributes to an indepth understanding of AL as an implicit emotion regulation strategy in the short term, i.e. as a strategy used directly in the emotionally charged situation, and expands that knowledge to also include the effect in individuals with a clinical diagnosis. Also, it provides the opportunity to evaluate the effect of the two week AL behavioral intervention using psychophysiological testing.

Conditions

Emotional Dysregulation

Keywords

Emotional Self-Regulation; Emotion Regulation; Affect labeling; Internet intervention

Outcome Measures

Primary Outcomes (1)

• Change in The Difficulties in Emotion Regulation Scale, DERS (Gratz & Roemer, 2004)

  Min 36, Max 180. Higher scores represents worse outcome

  At day 1 and at day 14 (+/- 5 days)

Secondary Outcomes (11)

• The Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

  At baseline and day 14 (+/- 5 days)

• The Generalized Anxiety Disorder 7-item Scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006).

  At baseline and day 14 (+/- 5 days)

• The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)

  At day 1 and day 14 (+/- 5 days)

• The Toronto Alexithymia Scale (TAS-20; Bagby et al., 1994).

  At baseline and day 14 (+/- 5 days)

• The Ruminative responses scale - Brooding and Reflection (RRS-BR; Treynor et al., 2003, Cronwall, 2019).

  At baseline and day 14 (+/- 5 days)

Study Arms (2)

Affect Labeling_direct

EXPERIMENTAL

Randomized to immediate two-week, internet delivered psychoeducative course in affect labeling

Behavioral: Affect labeling

Wait-list

NO INTERVENTION

Randomized to a two-week wait-list control

Interventions

Affect labeling BEHAVIORAL

Short behavioral intervention teaching affect labeling

Affect Labeling_direct

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sufficient skills in Swedish to be able to fill in self-assessment questionnaires.
• State at least a 3 (or higher) out of 10 regarding everyday difficulties with emotion regulation according to a scale created for this purpose: Do you feel that you currently have problems regulating your emotions? Circle the number that is best for you "(0 no problems at all, 10 Very severe problems.
• Answer "Yes, very much" or "Yes" to the following question: "Would you like to learn to regulate/manage your emotions better?" with the options "Yes, very much / Yes / Maybe, but doubtful if it is worth the effort, does not fit right now / No".

You may not qualify if:

• Psychiatric or somatic status that may prevent the participant from completing the experiment or require some form of care intervention the participant does not already undergo.
• Medium to high risk of suicide.
• Moderate to severe self-harming behavior.
• Blood phobia.
• Regular medication with benzodiazepines (including sleep medication, ex Stilnoct).
• Ongoing treatment with emotion regulation elements.
• To be part of the clinical group, the participant must state a diagnosis established by a medical professional in the last 5 years, which involves clinical difficulties with emotion regulation such as binge eating disorder, emotional instability, generalized anxiety, depression, social anxiety or ADHD, and does not plan to start, change or discontinue any psychosocial or pharmacological treatment within the next 4 weeks. The non-clinical group must not have been diagnosed or treated for mental illness in the last 5 years.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, department of clinical neuroscience

Stockholm, Stockholm County, 17177, Sweden

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Hanna Sahlin, Med Dr

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD

Model Details: within-individual and randomized control design

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: April 1, 2021
• Study Start: January 11, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

SE (1)