Targeting Components of Distress Tolerance

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 Overview

• Status: Recruiting
• Conditions: Distress, Emotional
• Intervention / Treatment: Behavioral: Psychoeducation; Behavioral: Self-Efficacy; Behavioral: Willingness

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer C Veilleux, PhD; Phone Number: 479-575-5329; Email: jcveille@uark.edu

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72701
      • Recruiting
      • University of Arkansas - Fayetteville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Work or School that does not allow consistent access to phone (or is unsafe)
• No internet access for completing follow-up surveys

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Psychoeducational Control; Participants will receive psychoeducation only	Behavioral: Psychoeducation; Psychoeducation about the components and functions of emotion.
Experimental: Self-Efficacy (Only); 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.	Behavioral: Psychoeducation; Psychoeducation about the components and functions of emotion.; Behavioral: Self-Efficacy; Brief skills based psychotherapy session to increase perceived self-efficacy for withstanding distress, giving participants increased beliefs that they *can* do it.
Experimental: Willingness (Only); 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.	Behavioral: Psychoeducation; Psychoeducation about the components and functions of emotion.; Behavioral: Willingness; Brief skills based psychotherapy session to increase perceived willingness to engage with distress for withstanding distress, giving participants increased motivation to try.
Experimental: Combined Willingness and Self-Efficacy; 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.	Behavioral: Psychoeducation; Psychoeducation about the components and functions of emotion.; Behavioral: Self-Efficacy; Brief skills based psychotherapy session to increase perceived self-efficacy for withstanding distress, giving participants increased beliefs that they *can* do it.; Behavioral: Willingness; Brief skills based psychotherapy session to increase perceived willingness to engage with distress for withstanding distress, giving participants increased motivation to try.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.")	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.")	Assessed 5x/day via ecological momentary assessment
GAD-7	Symptoms of anxiety	Baseline, weekly for three weeks and then after one month followup
PHQ-9	symptoms of depression	Baseline, weekly for three weeks and then after one month followup
AUDIT	Alcohol misuse	Baseline, weekly for three weeks and then after one month followup
Binge Eating Disorder Scale	binge eating symptoms	Baseline, weekly for three weeks and then after one month followup
DSM Cross-Cutting Symptom Measure	symptoms of psychopathology	Baseline, weekly for three weeks and then after one month followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Life Scale (SWLS)	life satisfaction	Baseline, weekly for three weeks and then after one month followup
Self-Compassion Scale - Short	self-criticism and self-compassion	Baseline, weekly for three weeks and then after one month followup
State Loss of Interest and Pleasure Scale	anhedonia	Baseline, weekly for three weeks and then after one month followup
Rumination and Reflection Questionnaire	rumination and self-reflective tendencies	Baseline, weekly for three weeks and then after one month followup

Collaborators and Investigators

• Sponsor: University of Arkansas, Fayetteville

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1R15MH136626-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No