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Clinical Trials/NCT06969053
NCT06969053RecruitingNot Applicable

Evaluation of Mindfulness Intervention Therapy in Treating Chronic Insomnia (CI) With Comorbid Anxiety

Xuanwu Hospital, Beijing1 site in 1 country70 target enrollmentStarted: November 1, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
70
Locations
1
Primary Endpoint
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
8 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosed with Insomnia Disorder according to DSM-5 criteria.
  • •Pittsburgh Sleep Quality Index (PSQI) total score >
  • •Age 8 years or older.
  • •Educational level of at least junior high school.
  • •Voluntarily agree to participate and provide written informed consent.
  • •Presence of anxiety symptoms, defined as Hamilton Anxiety Rating Scale (HAMA) score ≥ 14.

Exclusion Criteria

  • •Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
  • •Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
  • •Pregnant or breastfeeding women.
  • •Currently undergoing any psychological therapy.

Arms & Interventions

MIT + SHE

Experimental

Intervention: Mindfulness Intervention Therapy plus Sleep Hygiene Education (Behavioral)

SHE only

Active Comparator

Intervention: Sleep Hygiene Education (Behavioral)

Outcomes

Primary Outcomes

The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks

Time Frame: Baseline, 6 weeks

The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

Secondary Outcomes

  • The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months.)
  • The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
  • The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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