The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People

NCT06087484 | Unknown

• 1 other identifier: E20230922
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring the Effectiveness of a mindfulness intervention for Insomniacs with Emotional Distress Comparing the intervention effects of two mindfulness interventions

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (6)

• 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• 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

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• . 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.

  pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

• 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.

  pre-intervention; after the 3rd week intervention; after the 7-week intervention; one month after intervention

• 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

  pre-intervention; after the 3rd week intervention; after the 7-week intervention;one month after intervention

Study Arms (2)

MIED-I group

EXPERIMENTAL

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.

Behavioral: Mindfulness Intervention for Emotional Distress and Insomnia (MIED-I)

Waitlist control group

NO INTERVENTION

Interventions

Mindfulness Intervention for Emotional Distress and Insomnia (MIED-I) BEHAVIORAL

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

MIED-I 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:

• \- 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

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

Xing Ren

CONTACT

13998397642; 1297995267@qq.com

Xinghua Liu

CONTACT

13371669818; xinghua_liu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: October 16, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 28, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)