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Recruiting NCT06570603

Targeting Components of Distress Tolerance

No phase Interventional Distress, Emotional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-Efficacy, Willingness, Psychoeducation.
Who it may be relevant to
Registry conditions: Distress, Emotional. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • 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.
  • Behavioral Psychoeducation
    Psychoeducation about the components and functions of emotion.

Primary outcome measures

  • Engagement behaviors [Time frame: Assessed 5x/day via ecological momentary assessment]
  • Disengagement behaviors [Time frame: Assessed 5x/day via ecological momentary assessment]
  • GAD-7 [Time frame: Baseline, weekly for three weeks and then after one month followup]
  • PHQ-9 [Time frame: Baseline, weekly for three weeks and then after one month followup]
  • AUDIT [Time frame: Baseline, weekly for three weeks and then after one month followup]
  • Binge Eating Disorder Scale [Time frame: Baseline, weekly for three weeks and then after one month followup]
  • DSM Cross-Cutting Symptom Measure [Time frame: Baseline, weekly for three weeks and then after one month followup]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Arkansas - Fayetteville — Fayetteville

Identifiers

NCT: NCT06570603 · 1R15MH136626-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗