Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06087484 |
| Other study ID # |
E20230922 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 16, 2023 |
| Est. completion date |
January 28, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Peking University |
| Contact |
Xing Ren |
| Phone |
13998397642 |
| Email |
1297995267[@]qq.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Exploring the Effectiveness of a mindfulness intervention for Insomniacs with Emotional
Distress Comparing the intervention effects of two mindfulness interventions
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.
