The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People

NCT ID: NCT06087484

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-01-28

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 (Mindfulness Intervention for Emotional Disturbance) program has shown significant improvements in the mental health of patients with anxiety and depression. Meanwhile, if investigators 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.

Conditions

Emotional Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIED-I group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Waitlist control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Xinghua Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinghua Liu

Role: PRINCIPAL_INVESTIGATOR

School of Psychological and Cognitive Sciences, Peking University

Locations

Peking University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xing Ren

Role: CONTACT

1297995267@qq.com

13998397642

Xinghua Liu

Role: CONTACT

xinghua_liu@pku.edu.cn

13371669818

Facility Contacts

Xinghua Liu

Role: primary

xinghua_liu@pku.edu.cn

+86 13371669818

Other Identifiers

E20230922

Identifier Type: -

Identifier Source: org_study_id