Mechanisms of Mindfulness Intervention: Distress Tolerance Dose Manipulation

NCT06056232 | Unknown

• 1 other identifier: E20230919
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study hopes to:

1. 1.explore whether an increase in the dosage of distress tolerance intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress.
2. 2.explore whether distress tolerance mediates the effects of mindfulness intervention on alleviating emotional distress.

Conditions

Emotional Distress; Emotional Disorder

Outcome Measures

Primary Outcomes (15)

• Changes of Five Facet Mindfulness Questionnaire-short form during the intervention

  The Five Facet Mindfulness Questionnaire is a self-reported questionnaire measuring mindfulness levels. Scores range from 39 to 195, with higher scores indicating higher levels of mindfulness.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Distress Tolerance Scale during the intervention

  Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Discomfort Intolerance Scale during the intervention

  Discomfort Intolerance Scale is used to measure Discomfort Intolerance. Scores range from 0 to 25, with higher scores indicating higher levels of discomfort intolerance.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Chinese Perceived Stress Scale during the intervention

  The Chinese Perceived Stress Scale is a self-reported questionnaire measuring stress. Scores range from 0 to 56, with higher scores indicating higher levels of stress.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of 10-item Kessler Psychological Distress Scale during the intervention

  The 10-item Kessler Psychological Distress Scale is a self-reported questionnaire measuring distress. Scores range from 10 to 50, with higher scores indicating higher levels of distress.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Overall Anxiety Severity and Impairment Scale during the intervention

  The Overall Anxiety Severity and Impairment Scale is a self-reported questionnaire measuring anxiety. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Overall Depression Severity and Impairment Scale during the intervention

  The Overall Depression Severity and Impairment Scale is a self-reported questionnaire measuring depression. Scores range from 0 to 20, with higher scores indicating higher levels of depression.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Beck Depression Inventory during the intervention

  Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Beck Anxiety Inventory during the intervention

  Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Athens Insomnia Scale during the intervention

  The Athens Insomnia Scale is a self-reported questionnaire measuring sleepy quality. Scores range from 0 to 24, with lower scores indicating higher levels of sleep quality.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Rumination during the intervention

  the Rumination subscale, extracted from the Rumination-Reflection Questionnaire, contains 12 items. Scores range from 5 to 60, with higher scores indicating higher levels of rumination.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention

  Chinese version of the Brief Experiential Avoidance Questionnaire scale is used to measure experiential avoidance. Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Patient Health Questionnaire during the intervention

  he Patient Health Questionnaire is a self-reported questionnaire consisting of 18 items designed to measure the degree of being troubled by various common physical symptoms. Scores range from 0 to 30. 0\~4 scores: no physical symptoms; 5\~9 scores: mild physical symptoms; 10\~14 scores: moderate physical symptoms; 15\~30 scores: severe physical symptoms.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of behavioral inhibition system/behavioral activation system (BIS/BAS) scale during the intervention

  The BIS/BAS scale is a self-report questionnaire consisting of 18 items designed to assess the intensity of two motivational systems, namely the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS). Scores on this scale can vary between 18 and 72, with elevated scores indicative of a greater tendency to avoid aversive outcomes and pursue goal-oriented outcomes.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

• Changes of Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) scale during the intervention

  The Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) is a self-report questionnaire that aims to measure Interoceptive Awareness. Scores range from 0 to 165. Higher scores indicate higher ability or tendency in several domains including Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-regulation, Body Listening, and Trusting.

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

Secondary Outcomes (1)

• The Paced Auditory Serial Addition Task-Computerized (PASAT-C)

  at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups

Study Arms (3)

MIED group

EXPERIMENTAL

Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces the nature and law of anxiety, depression, and other emotions, the source of anxiety, depression, and other emotional distress, and the strategies and methods to alleviate emotional distress. These exercises, knowledge, and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression, and other emotional problems.

Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-normal version

MIED+DT group

EXPERIMENTAL

The increase in distress tolerance dosage involves incorporating additional psychoeducational content related to distress tolerance and corresponding exercises to enhance distress tolerance within the MIED (Mindfulness Intervention for Emotional Distress) program.

Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-increase distress tolerance

MIED-DT group

EXPERIMENTAL

The decrease in distress tolerance dosage entails reducing exercises related to distress tolerance within the MIED, such as interoceptive exposure exercises and challenging tasks.

Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-decrease distress tolerance

Interventions

Mindfulness Intervention for Emotional Distress(MIED)-normal version BEHAVIORAL

Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces the nature and law of anxiety, depression, and other emotions, the source of anxiety, depression, and other emotional distress, and the strategies and methods to alleviate emotional distress. These exercises, knowledge and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression and other emotional problems.

MIED group

Mindfulness Intervention for Emotional Distress(MIED)-increase distress tolerance BEHAVIORAL

Increase the intervention dose of distress tolerance in Mindfulness Intervention for Emotional Distress (MIED). For example, including more emotion exposure tasks, materials from Facing Your Feelings.

MIED+DT group

Mindfulness Intervention for Emotional Distress(MIED)-decrease distress tolerance BEHAVIORAL

Decrease the intervention dose of distress tolerance in Mindfulness Intervention for Emotional Distress (MIED). For example, including less emotion exposure tasks and interoceptive exposure tasks.

MIED-DT group

Eligibility Criteria

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

You may qualify if:

• Age 18-65;
• Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
• If taking medication, haven't changed for at least 4 weeks before intervention onset and no change in medicine is expected;
• Voluntary participation in this study and sign an informed consent form.

You may not qualify if:

• Subjects who have participated in mindfulness-based projects (especially MIED), and/or the current frequency of meditation practice is more than once a week;
• Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder, and generalized developmental disorder;
• Subjects at risk of suicide.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanjuan Li

CONTACT

+86 15992425499; Lyjanice@stu.pku.edu.cn

Study Design

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

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: October 5, 2023
• Primary Completion: December 8, 2023
• Study Completion: March 10, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)