Targeting Components of Distress Tolerance

NCT06570603 | Recruiting DMC

• 1 other identifier: 1R15MH136626-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Distress, Emotional

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Satisfaction with Life Scale (SWLS)

  Baseline, weekly for three weeks and then after one month followup

• Self-Compassion Scale - Short

  Baseline, weekly for three weeks and then after one month followup

• State Loss of Interest and Pleasure Scale

  Baseline, weekly for three weeks and then after one month followup

• Rumination and Reflection Questionnaire

  Baseline, weekly for three weeks and then after one month followup

Study Arms (4)

Psychoeducational Control

PLACEBO COMPARATOR

Participants will receive psychoeducation only

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.

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.

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.

Behavioral: Self-Efficacy; Behavioral: Willingness; Behavioral: Psychoeducation

Interventions

Self-Efficacy BEHAVIORAL

Brief skills based psychotherapy session to increase perceived self-efficacy for withstanding distress, giving participants increased beliefs that they \*can\* do it.

Combined Willingness and Self-Efficacy; Self-Efficacy (Only)

Willingness BEHAVIORAL

Brief skills based psychotherapy session to increase perceived willingness to engage with distress for withstanding distress, giving participants increased motivation to try.

Combined Willingness and Self-Efficacy; Willingness (Only)

Psychoeducation BEHAVIORAL

Psychoeducation about the components and functions of emotion.

Combined Willingness and Self-Efficacy; Psychoeducational Control; Self-Efficacy (Only); Willingness (Only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead

Study Sites (1)

University of Arkansas - Fayetteville

Fayetteville, Arkansas, 72701, United States

RECRUITING

Central Study Contacts

Jennifer C Veilleux, PhD

CONTACT

479-575-5329; jcveille@uark.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: August 26, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-04

Locations

US (1)