A Trial of Mindfulness Meditation for Chronic Insomnia

NCT03337061 | Withdrawn

• 1 other identifier: 174084
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy of mediation therapies on measures of sleep and arousal for people with chronic insomnia and with this the viability of smartphone delivered meditation based approaches at a population level.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• Change in Insomnia Severity (Insomnia Severity Index)

  Insomnia Severity Index (ISI): The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. This will be administered at baseline, after 8-weeks and at a 3 and 6-month follow-up. The index will be sent to by post and. It will take approximately 5 minutes to complete.

  8 weeks, 3 and 6 month follow-up

• Change in Actigraphy determined wake time (TWT)

  Actigraphy: Sleep onset latency (SOL) and wake after sleep onset (WASO) will be determined using wrist actigraphy. Participants will be provided with an actiwatch during the screening interview conducted at the beginning of the study. The actiwatch will be worn on the non-dominant arm 24 hours a day, except for while bathing, during the 2-week screening period. Additionally, the actiwatch will be worn for one week after the 8-week intervention and for one week prior to the 3 and 6-month follow-up. Participants will send the actiwatch to the investigator by post after each measurement period. The actiwatch will be sent to participants by post before the next measurement point; apart from the first time point where the participant will be given the actiwatch.

  2-week screening, 8-week intervention, 3 and 6-month follow-up

Secondary Outcomes (2)

• Review of mobile-based mindfulness meditation application for insomnia

  6 months

• Mindfulness (CAMS-R)

  Baseline, 8-weeks, 3 and 6-month follow-up

Study Arms (2)

Experimental (Mindfulness)

EXPERIMENTAL

This arm will receive mindfulness-based interventions through a mobile application

Other: Mindfulness Meditation

Control (Sleep Advice)

NO INTERVENTION

This is the control arm that will receive usual care

Interventions

Mindfulness Meditation OTHER

Mindfulness Meditation delivered through a mobile application

Experimental (Mindfulness)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18
• Meet the diagnostic criteria for an insomnia disorder. Defined as difficulty initiating or maintaining sleep despite adequate opportunity, with at least one symptom of an associated daytime impairment. Additional quantitative insomnia criteria following research recommendations include frequency (defined as sleep onset latency (SOL) or wake after sleep onset (WASO) \> 30 minutes at least 3 nights per week and for chronicity, defined as symptoms lasting \> 6 months.
• Have access to an iOS or Android smartphone or a desktop computer with Internet access
• Participants will be required to sign an informed consent form

You may not qualify if:

• Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study
• Uncontrolled psychiatric conditions requiring immediate treatment outside of the study, including current major depressive episode
• Comorbid sleep disorders including obstructive sleep apnea
• Current use of hypnotic or sedating medications for the purpose of insomnia
• Inadequate proficiency in English to complete the protocol
• Participation in other trials concurrently
• Regular meditation practice defined as equal to or more than 2x weekly for the past 30 days

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicholas Hart, MD

  Guys and St Thomas NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 8, 2017
• Study Start: May 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share