Clinical trial NCT06056232: Mechanisms of Mindfulness Intervention: Distress Tolerance Dose Manipulation
Official title: Exploring the Mechanism of Mindfulness Intervention: Manipulating Distress the Dose of Tolerance Intervention Dose
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Distress
Emotional Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study hopes to:

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

Detailed description: Epidemiological findings in "The Lancet Psychiatry" indicated that anxiety disorders, including generalized anxiety disorder, panic disorder, and social anxiety disorder, are the most prevalent category of disorders in China, with a lifetime prevalence of 7.6%. Depression follows closely with a lifetime prevalence of 6.8%. With the outbreak of the COVID-19 pandemic in 2020, the prevalence of both anxiety and depressive disorders increased. However, the current availability of psychological intervention resources in China is inadequate to meet the demand. This underscores the critical importance of developing effective and efficient psychological intervention approaches, as well as investigating their effectiveness and mechanisms to optimize intervention strategies.

In recent years, mindfulness-based interventions (MBIs) have been increasingly applied to alleviate emotional distress in both clinical and non-clinical populations, with their efficacy widely supported. Additionally, numerous researchers have explored the mechanisms underlying mindfulness and MBIs, proposing various theories. One of the mechanisms frequently suggested by researchers is exposure. However, there has been limited direct investigation into the mechanisms of exposure and its related processes or abilities. Distress tolerance (DT) is closely associated with exposure and is considered a common etiological factor or transdiagnostic characteristic of emotional distress, including anxiety and depression. Nevertheless, few studies have explored the mechanisms of how mindfulness interventions alleviate emotional distress from the perspective of exposure and the transdiagnostic characteristics of anxiety and depression. This lack of research hampers our ability to obtain sufficient information to develop or enhance mindfulness-based intervention methods to assist individuals with emotional disorders or highly emotionally distressed subclinical populations.

This study is grounded in the critical role of DT in the generation and maintenance of emotional distress, as well as the mindfulness principle of approaching pain with awareness and acceptance (non-judgmental and non-reactive). It posits that DT might be a potential mechanism through which mindfulness interventions alleviate emotional distress. Following the criteria for establishing mechanisms, this research investigates this issue. Based on the current state of research, DT as a mechanism for MBIs to alleviate emotional distress meets the plausibility criterion and partially satisfies the strong association criterion and experimental manipulation criterion. However, further research is needed to assess its consistency criterion, temporal precedence criterion, and gradient criterion.

The current study primarily focuses on the experimental manipulation and gradient criteria. The aim is to examine whether the mechanism of DT meets the experimental manipulation and gradient criteria by adjusting the content of the mindfulness intervention for emotional distress (MIED) program, which can directly impact distress tolerance and manipulate the dosage of distress tolerance intervention.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes of Five Facet Mindfulness Questionnaire-short form during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Distress Tolerance Scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Discomfort Intolerance Scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Chinese Perceived Stress Scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of 10-item Kessler Psychological Distress Scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Overall Anxiety Severity and Impairment Scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Overall Depression Severity and Impairment Scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Beck Depression Inventory during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Beck Anxiety Inventory during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Athens Insomnia Scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Rumination during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Patient Health Questionnaire during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of behavioral inhibition system/behavioral activation system (BIS/BAS) scale during the intervention
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Changes of Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) scale during the intervention
timeFrame: 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:
measure: The Paced Auditory Serial Addition Task-Computerized (PASAT-C)
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
affiliation: School of Psychological and Cognitive Sciences, Peking University
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: