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The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People

Primary Purpose

Emotional Distress

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mindfulness Intervention for Emotional Distress and Insomnia (MIED-I)
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Distress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Subjects with scores greater than 21 on the Kessler Psychological Distress Scale, and Pittsburgh sleep quality index scores greater than 5, Insomnia severity index's scores greater than 8 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.

Sites / Locations

  • Peking University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MIED-I group

Waitlist control group

Arm Description

provide standard audio instructions for mindfulness exercises, introduce 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 sleep problems counseling and treatment, and their application in daily life can help alleviate anxiety, depression and insomnia.

Outcomes

Primary Outcome Measures

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.
Weekly 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
Weekly 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.
. Weekly 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.
Weekly changes of Insomnia severity index during the intervention
The ISI is a self-report scale used to detect the severity of insomnia, with scores ranging from 0 to 28; the higher the score, the more severe the insomnia.
Weekly changes of Pittsburgh sleep quality index during the intervention
The Pittsburgh Sleep Index is a self-measured scale used to measure the quality of sleep over the past month, higher the score, the poorer the quality of sleep

Secondary Outcome Measures

Full Information

First Posted
October 12, 2023
Last Updated
October 12, 2023
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT06087484
Brief Title
The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People
Official Title
The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
January 23, 2024 (Anticipated)
Study Completion Date
January 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Exploring the Effectiveness of a mindfulness intervention for Insomniacs with Emotional Distress Comparing the intervention effects of two mindfulness interventions
Detailed Description
Insomnia is a term used to refer to "not sleeping well," which can include difficulty falling asleep at night, excessive dreaming, frequent awakenings that make it difficult to fall asleep, waking up too early, and other symptoms of dissatisfaction with the length and quality of sleep. Some scholars believe that insomnia also belongs to a type of emotional disorder. Although few studies have been able to definitively describe insomniacs' responses to negative emotions, insomniacs inhibit or avoid efforts to suppress emotional experiences in relation to sleep disorders, and insomnia has been associated with the use of sleep-related safety behaviors, which are a form of avoidant coping that maintains symptoms by reinforcing maladaptive belief. Also, 40% of insomniacs have comorbid psychiatric disorders. Longitudinal studies have shown that anxiety and depression present with sleep problems are more severe and also increase the risk of illness. Thus, the relationship between sleep problems and anxiety and depression may be bidirectional. For example, the close association between insomnia and depression may be due to the fact that sleep and mood regulation share underlying pathophysiological mechanisms, and there may be some neuroendocrine similarities between insomnia and depression. All of this evidence suggests that insomnia and comorbid psychiatric disorders can lead to a vicious cycle of reciprocal causation and, at the same time, are likely to respond to the same therapeutic interventions. In such a context, SCT, SRT, and CBT-I therapies that solely target insomnia symptoms may not bring more benefits to patients beyond insomnia symptom relief and do not address the cycle between insomnia and anxiety and depression. Therefore, the development and availability of alternative treatment modalities can improve insomnia patients' access to psychotherapy, as well as the overall efficiency of treatment. There is now a large body of evidence that various forms of positive mindfulness-based interventions can be effective in improving sleep quality and alleviating insomnia symptoms, and can thus be an adjunct to sleep therapy, but there is still room for improvement. The original positive thought-based intervention programs for insomnia, such as MBSR, MBCT, and MBT-I, are all conducted offline, etc., and are susceptible to a variety of additional factors. As an emerging intervention program for insomnia, the number of therapists who can master MBT-I is even more limited. There is preliminary evidence that the MIED (Mood Intervention for Emotional Disturbance) program has shown significant improvements in the mental health of patients with anxiety and depression. Meanwhile, if we follow the above scholars' analysis of insomnia, which is also a type of emotional disorder, then through the MIED program, participants can relieve both anxiety and depression and insomnia, which is more cost-effective than the previous program that only focuses on insomnia. which is more cost-effective than the previous positive thinking intervention program for insomnia only. This study proposes to develop a special version of the original MIED program, the Mindfulness Intervention for Emotional Distress and Insomnia (MIED-I). Adding part of the original CBT-I, the gold standard for insomnia treatment, this part of the adjustment will be mainly reflected in the psycho-education for insomnia, while keeping the basic framework of the original four strategies of MIED and the corresponding explanations and exercises unchanged, but at the same time, more directly to solve the main insomnia disturbances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIED-I group
Arm Type
Experimental
Arm Description
provide standard audio instructions for mindfulness exercises, introduce 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 sleep problems counseling and treatment, and their application in daily life can help alleviate anxiety, depression and insomnia.
Arm Title
Waitlist control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Intervention for Emotional Distress and Insomnia (MIED-I)
Intervention Description
The MIED-I program integrates the rationales and practices from the Unified Protocol for Treatment of Emotional Disorders (UP) and Mindfulness based Interventions. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from Mindfulness based intervention (MBIs).Also, a portion of the CBT-I will be added to the course to provide psychoeducation for insomnia. Variables that have been shown to be effective in interventions for insomnia in past studies, such as awareness, non-responsiveness, and self-compassion, will also be added to better alleviate insomnia symptoms
Primary Outcome Measure Information:
Title
Changes of Five Facet Mindfulness Questionnaire-short form during the intervention
Description
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.
Time Frame
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Title
Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
Description
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
Time Frame
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Title
Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
Description
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.
Time Frame
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Title
. Weekly changes of Overall Depression Severity and Impairment Scale during the intervention
Description
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.
Time Frame
pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Title
Weekly changes of Insomnia severity index during the intervention
Description
The ISI is a self-report scale used to detect the severity of insomnia, with scores ranging from 0 to 28; the higher the score, the more severe the insomnia.
Time Frame
pre-intervention; after the 3rd week intervention; after the 7-week intervention; one month after intervention
Title
Weekly changes of Pittsburgh sleep quality index during the intervention
Description
The Pittsburgh Sleep Index is a self-measured scale used to measure the quality of sleep over the past month, higher the score, the poorer the quality of sleep
Time Frame
pre-intervention; after the 3rd week intervention; after the 7-week intervention;one month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Subjects with scores greater than 21 on the Kessler Psychological Distress Scale, and Pittsburgh sleep quality index scores greater than 5, Insomnia severity index's scores greater than 8 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xing Ren
Phone
13998397642
Email
1297995267@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghua Liu
Phone
13371669818
Email
xinghua_liu@pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinghua Liu
Organizational Affiliation
School of Psychological and Cognitive Sciences, Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100871
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinghua Liu
Phone
+86 13371669818
Email
xinghua_liu@pku.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People

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