Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment

NCT ID: NCT04364191

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2022-08-30

Brief Summary

Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment. To address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. The findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.

Conditions

Mild Cognitive Impairment; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention Arm

Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.

Group Type: EXPERIMENTAL

Multicomponent Behavioral Sleep Intervention for Insomnia

Intervention Type: BEHAVIORAL

The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.

Control Arm

Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).

Group Type: ACTIVE_COMPARATOR

Active Control

Intervention Type: BEHAVIORAL

The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.

Interventions

Multicomponent Behavioral Sleep Intervention for Insomnia

The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.

Intervention Type: BEHAVIORAL

Active Control

The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 1) age 55 and older
• 2) mild cognitive impairment (MCI) The Telephone Interview for Cognitive Status 13-item modified (TICS-M) version will be used to screen participants for eligibility in the study. We will include participants with TICS-M scores of 28-36, based off ranges and optimal cutpoints determined in various studies.
• 3) have insomnia symptoms a)answer yes to "Do you have trouble falling asleep, staying asleep, awakening too early, or have unrefreshing sleep" and b) have subjective sleep diary evidence of insomnia, with an average sleep onset latency >30 min or wakefulness after sleep onset of >60 min during the one week pre-treatment assessment
• 4) live in the community
• 5) speak English as primary language

Exclusion Criteria

• 1) Presence of moderate to severe cognitive impairment defined as TICS score <28
• 2) Visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting a number at 24 point font
• 3) Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
• 4) Presence of an acute medical or psychiatric condition which, in the judgement of the research team, would interfere with the subject's ability to realistically follow the study protocol

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23NR018487

Identifier Type: NIH

Identifier Source: secondary_id

View Link

832826

Identifier Type: -

Identifier Source: org_study_id