Distress, EmotionalNCT06570603
Targeting Components of Distress Tolerance
A study testing Self-Efficacy, Willingness and Psychoeducation in people with Distress, Emotional, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn which aspects of distress intolerance (i.e., difficulties withstanding upsetting emotional states) are the most important for improving effective emotion regulation and associated mental health symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Emotional
- What is being tested?
- Self-Efficacy, Willingness and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English
- Uses Android or iPhone smartphone
- Depression Anxiety and Stress Scale (DASS-21) scores of 42 and higher
- Distress Intolerance Index (DII) scores of 3 or higher
Who cannot join
- Work or School that does not allow consistent access to phone (or is unsafe)
- No internet access for completing follow-up surveys
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas - Fayetteville
Fayetteville, Arkansas, 72701
About this study
The goal of this clinical trial is to learn which aspects of distress intolerance (i.e., difficulties withstanding upsetting emotional states) are the most important for improving effective emotion regulation and associated mental health symptoms.
The main questions it aims to answer are:
Read more
How are willingness to feel upset and self-efficacy for withstanding distress associated with different emotion regulation strategies used in daily life?
Does targeting willingness to feel upset and/or self-efficacy for withstanding distress help people use more effective emotion regulation strategies in daily life when they feel upset?
Are improvements in emotion regulation strategies in daily life associated with fewer symptoms of mental health problems over time?
Participants will:
Answer questions about their moods, willingness to feel upset, self-efficacy for withstanding distress and emotion regulation strategies for three weeks using a cell phone app
Undergo a willingness, self-efficacy, combined or psychoeducational control intervention in the lab
Be prompted to use the intervention skill via the cell phone app during the second week, after the intervention
Complete weekly reports of mental health symptoms
- Conditions
- Distress, Emotional
- Being tested
- Self-Efficacy, Willingness, Psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-EfficacyBehavioural
Brief skills based psychotherapy session to increase perceived self-efficacy for withstanding distress, giving participants increased beliefs that they *can* do it.
WillingnessBehavioural
Brief skills based psychotherapy session to increase perceived willingness to engage with distress for withstanding distress, giving participants increased motivation to try.
PsychoeducationBehavioural
Psychoeducation about the components and functions of emotion.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational Control | Placebo comparator | Participants will receive psychoeducation only Receives: Behavioral: Psychoeducation |
| Self-Efficacy (Only) | Experimental | Single session intervention focusing on increasing self-efficacy to manage distress. Will include brief psychoeducation about emotion, then a focus on agency and self-criticism, using stressors the participant provided from the previous week, with an aim to teach self-compassion skills that will improve self-efficacy. Receives: Behavioral: Self-Efficacy; Behavioral: Psychoeducation |
| Willingness (Only) | Experimental | Single session intervention focused on increasing willingness to allow distress. Will include brief psychoeducation about emotion, then a discussion of values and how allowing and experiencing emotions nourishes values, experiencing discomfort enhances growth. Will use stressors from the prior week as examples. Receives: Behavioral: Willingness; Behavioral: Psychoeducation |
| Combined Willingness and Self-Efficacy | Experimental | Single session intervention focused on increasing both willingness and self-efficacy. Will include brief psychoeducation about emotion, then a combination of using values and self-compassion to increase both allowing and self-efficacy. Receives: Behavioral: Self-Efficacy; Behavioral: Willingness; Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement behaviors
Emotion regulation strategies reflective of engagement; these are new items developed for this study and are not from an established scale. All items will be rated from 0 (not at all) to 6 (extremely). There will be 7 items assessing labeling ("I'm using emotion words to describe how I feel right now"), processing ("I'm reflecting on or writing about my feelings"), sharing ("I'm sharing how I feel with another person"), physical feeling ("I'm intentionally feeling my feelings in my body"), curiously considering ("I'm curiously considering how my feelings came about"), defusion ("I'm observing my feelings without getting 'stuck' in them"), and importance ("I'm trying to think about how this current situation maps on to what matters.")
Measured: Assessed 5x/day via ecological momentary assessment
Disengagement behaviors
Emotion regulation strategies reflective of disengagement, some of which were modified from a momentary experiential avoidance measure (Hershenberg et al., 2017). All items will be rated from 0 (not at all) to 6 (extremely).Items will assess distraction ("Trying to distract myself from my feelings'), thought suppression ("Trying to push unwanted thoughts out of my mind."), discounting ("I'm telling myself I shouldn't be feeling the way I'm feeling"), expressive suppression ("I'm trying to control my feelings by not expressing them"), procrastination ("I'm intentionally putting of an unpleasant task until later"), denial ("I'm trying to 'turn off' the feelings that I don't want to feel"), and reduce importance ("Trying to think about the current situation as unimportant to me.")
Measured: Assessed 5x/day via ecological momentary assessment
GAD-7
Symptoms of anxiety
Measured: Baseline, weekly for three weeks and then after one month followup
PHQ-9
symptoms of depression
Measured: Baseline, weekly for three weeks and then after one month followup
AUDIT
Alcohol misuse
Measured: Baseline, weekly for three weeks and then after one month followup
Binge Eating Disorder Scale
binge eating symptoms
Measured: Baseline, weekly for three weeks and then after one month followup
DSM Cross-Cutting Symptom Measure
symptoms of psychopathology
Measured: Baseline, weekly for three weeks and then after one month followup
Secondary outcomes (4)
Satisfaction with Life Scale (SWLS)
life satisfaction
Measured: Baseline, weekly for three weeks and then after one month followup
Self-Compassion Scale - Short
self-criticism and self-compassion
Measured: Baseline, weekly for three weeks and then after one month followup
State Loss of Interest and Pleasure Scale
anhedonia
Measured: Baseline, weekly for three weeks and then after one month followup
Rumination and Reflection Questionnaire
rumination and self-reflective tendencies
Measured: Baseline, weekly for three weeks and then after one month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start3 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer C Veilleux, University of Arkansas, Fayetteville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570603
- Sponsor's protocol ID
- 1R15MH136626-01
- Status last verified
- Apr 2025
- First submitted
- 7 May 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Components of Distress Tolerance
- ClinicalTrials.gov ID
- NCT06570603
- Acronym / sponsor ID
- 1R15MH136626-01
- Conditions
- Distress, Emotional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 Aug 2024 (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 goal of this clinical trial is to learn which aspects of distress intolerance (i.e., difficulties withstanding upsetting emotional states) are the most important for improving effective emotion regulation and associated mental health symptoms.
The main questions it aims to answer are:
How are willingness to feel upset and self-efficacy for withstanding distress associated with different emotion regulation strategies used in daily life?
Does targeting willingness to feel upset and/or self-efficacy for withstanding distress help people use more effective emotion regulation strategies in daily life when they feel upset?
Are improvements in emotion regulation strategies in daily life associated with fewer symptoms of mental health problems over time?
Participants will:
Answer questions about their moods, willingness to feel upset, self-efficacy for withstanding distress and emotion regulation strategies for three weeks using a cell phone app
Undergo a willingness, self-efficacy, combined or psychoeducational control intervention in the lab
Be prompted to use the intervention skill via the cell phone app during the second week, after the intervention
Complete weekly reports of mental health symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational Control | Placebo comparator | Behavioral: PsychoeducationParticipants will receive psychoeducation only |
| Self-Efficacy (Only) | Experimental | Behavioral: Self-Efficacy, Behavioral: PsychoeducationSingle session intervention focusing on increasing self-efficacy to manage distress. Will include brief psychoeducation about emotion, then a focus on agency and self-criticism, using stressors the participant provided from the previous week, with an aim to teach self-compassion skills that will improve self-efficacy. |
| Willingness (Only) | Experimental | Behavioral: Willingness, Behavioral: PsychoeducationSingle session intervention focused on increasing willingness to allow distress. Will include brief psychoeducation about emotion, then a discussion of values and how allowing and experiencing emotions nourishes values, experiencing discomfort enhances growth. Will use stressors from the prior week as examples. |
| Combined Willingness and Self-Efficacy | Experimental | Behavioral: Self-Efficacy, Behavioral: Willingness, Behavioral: PsychoeducationSingle session intervention focused on increasing both willingness and self-efficacy. Will include brief psychoeducation about emotion, then a combination of using values and self-compassion to increase both allowing and self-efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fluent in English
- Uses Android or iPhone smartphone
- Depression Anxiety and Stress Scale (DASS-21) scores of 42 and higher
- Distress Intolerance Index (DII) scores of 3 or higher
Key exclusion criteria (2 listed)
- Work or School that does not allow consistent access to phone (or is unsafe)
- No internet access for completing follow-up surveys
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 |
|---|---|---|
| Self-EfficacyBrief skills based psychotherapy session to increase perceived self-efficacy for withstanding distress, giving participants increased beliefs that they *can* do it. | Behavioural | Combined Willingness and Self-Efficacy, Self-Efficacy (Only) |
| WillingnessBrief skills based psychotherapy session to increase perceived willingness to engage with distress for withstanding distress, giving participants increased motivation to try. | Behavioural | Combined Willingness and Self-Efficacy, Willingness (Only) |
| PsychoeducationPsychoeducation about the components and functions of emotion. | Behavioural | Combined Willingness and Self-Efficacy, Psychoeducational Control, Self-Efficacy (Only), Willingness (Only) |
Primary outcome
Engagement behaviors
Time frame: Assessed 5x/day via ecological momentary assessment
Emotion regulation strategies reflective of engagement; these are new items developed for this study and are not from an established scale. All items will be rated from 0 (not at all) to 6 (extremely). There will be 7 items assessing labeling ("I'm using emotion words to describe how I feel right now"), processing ("I'm reflecting on or writing about my feelings"), sharing ("I'm sharing how I feel with another person"), physical feeling ("I'm intentionally feeling my feelings in my body"), curiously considering ("I'm curiously considering how my feelings came about"), defusion ("I'm observing my feelings without getting 'stuck' in them"), and importance ("I'm trying to think about how this current situation maps on to what matters.")
Disengagement behaviors
Time frame: Assessed 5x/day via ecological momentary assessment
Emotion regulation strategies reflective of disengagement, some of which were modified from a momentary experiential avoidance measure (Hershenberg et al., 2017). All items will be rated from 0 (not at all) to 6 (extremely).Items will assess distraction ("Trying to distract myself from my feelings'), thought suppression ("Trying to push unwanted thoughts out of my mind."), discounting ("I'm telling myself I shouldn't be feeling the way I'm feeling"), expressive suppression ("I'm trying to control my feelings by not expressing them"), procrastination ("I'm intentionally putting of an unpleasant task until later"), denial ("I'm trying to 'turn off' the feelings that I don't want to feel"), and reduce importance ("Trying to think about the current situation as unimportant to me.")
GAD-7
Time frame: Baseline, weekly for three weeks and then after one month followup
Symptoms of anxiety
PHQ-9
Time frame: Baseline, weekly for three weeks and then after one month followup
symptoms of depression
AUDIT
Time frame: Baseline, weekly for three weeks and then after one month followup
Alcohol misuse
Binge Eating Disorder Scale
Time frame: Baseline, weekly for three weeks and then after one month followup
binge eating symptoms
DSM Cross-Cutting Symptom Measure
Time frame: Baseline, weekly for three weeks and then after one month followup
symptoms of psychopathology
4 secondary outcomes
Satisfaction with Life Scale (SWLS)
Time frame: Baseline, weekly for three weeks and then after one month followup
Self-Compassion Scale - Short
Time frame: Baseline, weekly for three weeks and then after one month followup
State Loss of Interest and Pleasure Scale
Time frame: Baseline, weekly for three weeks and then after one month followup
Rumination and Reflection Questionnaire
Time frame: Baseline, weekly for three weeks and then after one month followup
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Efficacy, Willingness and Psychoeducation in people with Distress, Emotional, run by University of Arkansas, Fayetteville at 1 site in United States.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Jul 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer C Veilleux, PhD (479-575-5329, jcveille@uark.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement behaviors (time frame: Assessed 5x/day via ecological momentary assessment). The study lists 7 primary outcomes in all. 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 10 Jul 2025.