Emotional DysregulationAL_ERNCT04826874
Affect Labeling - Experimental Evaluation and Behavioral Intervention
A study testing Affect labeling in people with Emotional Dysregulation, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Dysregulation
- What is being tested?
- Affect labeling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2023to 1 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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".
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, department of clinical neuroscience
Stockholm, Stockholm County, 17177
About this study
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.
Read the detailed description
Main study: AFFECT LABELING - DAILY EXERCISE IN PUTTING WORDS ON EMOTIONS DESIGN AND PROCEDURE This clinical study is a randomized, wait-list controlled design with repeated measurements. Participants are randomized at inclusion between being directly offered a 14-day course to train AL and waiting two weeks before beginning the intervention. Participants are blind to this randomization and do not know that they are in the waitlist condition, in order to avoid nocebo effects. The randomization is done 1: 1, and stratified by clinical categorization (participants with or without a psychiatric diagnosis).
The course is given via a secure web platform (BASS4) in which the participant also makes all their assessments, and interacts with the study material and their course leader (clinical psychologist or master level psychology students).
Intervention - web course in affect labeling The intervention is given as a two week internet-delivered course in using AL with the guidance of a course leader (licensed psychologist or psychologist assistant under supervision). The course is divided into two modules where module 1 contains a) Psychoeducation about different emotions and its function, b) Information about AL and its potential emotion-regulating effect, c) Instruction on how to use AL in everyday life and d) Planning of daily short exercises in naming emotions. Daily registration with multiple choice answers is introduced to help the practice of AL. All assessments are web-based and reminders are sent to the participants' cellphone. The course leader is active in providing feedback on the exercises and planning.
Module 2 is largely a continuation of module 1 where any obstacles and other difficulties are discussed in order to increase the chance of active practice in AL, and continued daily practice. Module 3 is a brief summary of what has been taught and is made available to the participant after post-assessment.
Laboratory sub-study: Participants will also participate in a laboratory-based study where the emotion regulating effect of AL will be compared with distraction or passive viewing while being exposed to emotionally provocative visual stimuli. Participants are exposed to 3 blocks of 8 images and questions about the images ("trials") with equal numbers of negative and neutral valence in three conditions: instruction to "Watch", instruction to use AL and instruction to use Distraction. The instructions and pictures are given in a randomized, balanced order. Before each block, a 3-second instruction is displayed that indicates whether the participant should use "Watch", "AL" or "Distraction" for all 8 images in the block.
All participants will carry out the laboratory sub-study on two occasions: before and after the 14 day period it takes for the individuals who directly receives the web-based course in AL to complete it.
- Conditions
- Emotional Dysregulation
- Being tested
- Affect labeling
- Keywords
- Emotional Self-Regulation, Emotion Regulation, Affect labeling, Internet intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect labelingBehavioural
Short behavioral intervention teaching affect labeling
| Study group | Role | What they receive |
|---|---|---|
| Affect Labeling_direct | Experimental | Randomized to immediate two-week, internet delivered psychoeducative course in affect labeling Receives: Behavioral: Affect labeling |
| Wait-list | No intervention | Randomized to a two-week wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Difficulties in Emotion Regulation Scale, DERS (Gratz & Roemer, 2004)
Min 36, Max 180. Higher scores represents worse outcome
Measured: At day 1 and at day 14 (+/- 5 days)
Secondary outcomes (11)
The Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Min 0, Max 27. Higher scores represents worse outcome
Measured: At baseline and day 14 (+/- 5 days)
The Generalized Anxiety Disorder 7-item Scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006).
Min 0, Max 21. Higher scores represents worse outcome
Measured: At baseline and day 14 (+/- 5 days)
The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Two sub scales: Cognitive reappraisal: Min 6 Max 42. Higher scores represents higher use of reappraisal. Suppression: Min 4 Max 28. Higher scores represents more use of suppression.
Measured: At day 1 and day 14 (+/- 5 days)
The Toronto Alexithymia Scale (TAS-20; Bagby et al., 1994).
Min 20, Max 100. Higher scores represents worse outcome
Measured: At baseline and day 14 (+/- 5 days)
The Ruminative responses scale - Brooding and Reflection (RRS-BR; Treynor et al., 2003, Cronwall, 2019).
Min 10 Max 40. Higher scores represents worse outcome
Measured: At baseline and day 14 (+/- 5 days)
the Client Satisfaction Questionnaire, 8 item (CSQ-8; Attkisson & Zwick, 1982).
Min 8 Max 32 Higher scores represents better outcome
Measured: At day 14 (+/- 5 days)
Levels of expected emotional upset
9-degree Likert scale. Min 1 (Not upset at all) Max 9 (Very upset).
Measured: At day 1 and day 14 (+/- 5 days)
Change in skin conductance response between three different emotion regulation conditions
changes in skin conductance, mean (micro-Siemens (μS)) between the different emotion regulation conditions
Measured: 3*8*5 seconds at Day 1 and at Day 14 (+/-5 days)
Change in Heart Rate Variability (HRV) (micro-Siemens (μS)) averaged over a 5 sec time window, and repeated 8 times per condition, ie. 8*5 seconds repeated 3 times.
Heart Rate Variability is a measure which indicates the variation in your heartbeats within a specific timeframe.
Measured: At day 1 and at day 14 (+/- 5 days)
Change in The Affect Labeling Questionnaire, ALQ (Sahi, et al. (in prep)
Min 12, Max 60. Higher scores represents better outcome
Measured: At day 1 and at day 14 (+/- 5 days)
Change in Experienced emotional upset (Time frame: averaged over a 5 sec time window, repeated 24 times during the experiment)
9-degree Likert scale. Min 1 (Not upset at all) Max 9 (Very upset).
Measured: At day 1 and day 14 (+/- 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start11 Jan 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- within-individual and randomized control design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Sahlin, Karolinska Institutet
- Investigators
- Hanna Sahlin, Med Dr, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826874
- Sponsor's protocol ID
- 2020-06427
- Acronym
- AL_ER
- Status last verified
- Apr 2025
- First submitted
- 15 Mar 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affect Labeling - Experimental Evaluation and Behavioral Intervention
- ClinicalTrials.gov ID
- NCT04826874
- Acronym / sponsor ID
- AL_ER / 2020-06427
- Conditions
- Emotional Dysregulation
- Keywords
- Emotional Self-Regulation, Emotion Regulation, Affect labeling, Internet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main study: AFFECT LABELING - DAILY EXERCISE IN PUTTING WORDS ON EMOTIONS DESIGN AND PROCEDURE This clinical study is a randomized, wait-list controlled design with repeated measurements. Participants are randomized at inclusion between being directly offered a 14-day course to train AL and waiting two weeks before beginning the intervention. Participants are blind to this randomization and do not know that they are in the waitlist condition, in order to avoid nocebo effects. The randomization is done 1: 1, and stratified by clinical categorization (participants with or without a psychiatric diagnosis).
The course is given via a secure web platform (BASS4) in which the participant also makes all their assessments, and interacts with the study material and their course leader (clinical psychologist or master level psychology students).
Intervention - web course in affect labeling The intervention is given as a two week internet-delivered course in using AL with the guidance of a course leader (licensed psychologist or psychologist assistant under supervision). The course is divided into two modules where module 1 contains a) Psychoeducation about different emotions and its function, b) Information about AL and its potential emotion-regulating effect, c) Instruction on how to use AL in everyday life and d) Planning of daily short exercises in naming emotions. Daily registration with multiple choice answers is introduced to help the practice of AL. All assessments are web-based and reminders are sent to the participants' cellphone. The course leader is active in providing feedback on the exercises and planning.
Module 2 is largely a continuation of module 1 where any obstacles and other difficulties are discussed in order to increase the chance of active practice in AL, and continued daily practice. Module 3 is a brief summary of what has been taught and is made available to the participant after post-assessment.
Laboratory sub-study: Participants will also participate in a laboratory-based study where the emotion regulating effect of AL will be compared with distraction or passive viewing while being exposed to emotionally provocative visual stimuli. Participants are exposed to 3 blocks of 8 images and questions about the images ("trials") with equal numbers of negative and neutral valence in three conditions: instruction to "Watch", instruction to use AL and instruction to use Distraction. The instructions and pictures are given in a randomized, balanced order. Before each block, a 3-second instruction is displayed that indicates whether the participant should use "Watch", "AL" or "Distraction" for all 8 images in the block.
All participants will carry out the laboratory sub-study on two occasions: before and after the 14 day period it takes for the individuals who directly receives the web-based course in AL to complete it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- within-individual and randomized control design
| Arm | Type | Receives |
|---|---|---|
| Affect Labeling_direct | Experimental | Behavioral: Affect labelingRandomized to immediate two-week, internet delivered psychoeducative course in affect labeling |
| Wait-list | No intervention | –Randomized to a two-week wait-list control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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".
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affect labelingShort behavioral intervention teaching affect labeling | Behavioural | Affect Labeling_direct |
Primary outcome
Change in The Difficulties in Emotion Regulation Scale, DERS (Gratz & Roemer, 2004)
Time frame: At day 1 and at day 14 (+/- 5 days)
Min 36, Max 180. Higher scores represents worse outcome
11 secondary outcomes
The Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time frame: At baseline and day 14 (+/- 5 days)
The Generalized Anxiety Disorder 7-item Scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006).
Time frame: At baseline and day 14 (+/- 5 days)
The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Time frame: At day 1 and day 14 (+/- 5 days)
The Toronto Alexithymia Scale (TAS-20; Bagby et al., 1994).
Time frame: At baseline and day 14 (+/- 5 days)
The Ruminative responses scale - Brooding and Reflection (RRS-BR; Treynor et al., 2003, Cronwall, 2019).
Time frame: At baseline and day 14 (+/- 5 days)
the Client Satisfaction Questionnaire, 8 item (CSQ-8; Attkisson & Zwick, 1982).
Time frame: At day 14 (+/- 5 days)
Levels of expected emotional upset
Time frame: At day 1 and day 14 (+/- 5 days)
Change in skin conductance response between three different emotion regulation conditions
Time frame: 3*8*5 seconds at Day 1 and at Day 14 (+/-5 days)
Change in Heart Rate Variability (HRV) (micro-Siemens (μS)) averaged over a 5 sec time window, and repeated 8 times per condition, ie. 8*5 seconds repeated 3 times.
Time frame: At day 1 and at day 14 (+/- 5 days)
Change in The Affect Labeling Questionnaire, ALQ (Sahi, et al. (in prep)
Time frame: At day 1 and at day 14 (+/- 5 days)
Change in Experienced emotional upset (Time frame: averaged over a 5 sec time window, repeated 24 times during the experiment)
Time frame: At day 1 and day 14 (+/- 5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Sahlin, Med Dr principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affect labeling in people with Emotional Dysregulation, run by Karolinska Institutet 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 3 inclusion and 7 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 9 Apr 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?
Change in The Difficulties in Emotion Regulation Scale, DERS (Gratz & Roemer, 2004) (time frame: At day 1 and at day 14 (+/- 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.