NCT03722316

Brief Summary

Background: Exposure to nature has a positive impact on a multitude of health-related outcomes such as stress, attention, recovery after surgery, and overall well-being. There is growing interest in determining the impact of vicarious nature experiences delivered through multimedia platforms on the well-being of persons at high risk for poor psychosocial outcomes, as is the case in older adults diagnosed with mild cognitive impairment (MCI) or mild dementia. Objectives/Purpose: The primary purpose of this study is to assess the feasibility of providing an immersive nature-based multimedia experience to older adults with MCI or mild dementia. A secondary purpose is to identify the potential health benefits of this intervention. Methodology: A convenience sample of 40 older adults (65+ years old) with and without mild cognitive complaints will be recruited from a Los Angeles senior service partner. Participation will include three visits. The first visit will include the consent process, cognitive testing, and questionnaire completion. The second and third visits will consist of a video session followed immediately by a group discussion regarding the content in the videos. The two video sessions will be administered in a randomized and counterbalanced manner one week apart. One video involves a 15-minute immersive nature-based experience and the other includes a 15-minute clip that presents emotionally "neutral" educational content. Both sessions will be immediately followed by a group discussion of the content in the videos and how it relates to past experiences. Outcomes and Analysis: Process evaluation data associated with recruitment, screening eligibility, involvement of personnel, assessment administration, and retention will be collected to determine overall study feasibility. Additionally, selected assessments will be administered at each multimedia experience during key time points to examine potential short-term health benefits.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

October 23, 2018

Last Update Submit

March 23, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Percent of Participants Retained

    The primary outcome of this study is to determine feasibility of study procedures. Retention is one component of feasibility. Retention will be measured as the % completing both video-based visits. Data will be recorded in a testing log.

    Initiation of recruitment, through study completion. Average of 6 months.

  • Recruitment rate

    The primary outcome of this study is to determine feasibility of study procedures. Recruitment rate is one component of feasibility. Recruitment rate will be defined as the % (of number approached) recruited over the duration of the recruitment period. We will also note % recruited from various sources. Data will be recorded in a recruitment log.

    Initiation of recruitment, through study completion. Average of 6 months.

  • Frequency and type of implementation barriers

    The primary outcome of this study is to determine feasibility of study procedures. Implementation barriers is one component of feasibility. Implementation barriers will be defined as the perceived challenges to assessment and intervention delivery on the part of the investigative team. Data sources will include team meeting discussions and study logs made by investigators during implementation.

    Initiation of recruitment, through study completion. Average of 6 months.

  • Number of discussion questions used during group discussion

    The primary outcome of this study is to determine feasibility of study procedures. Intervention fidelity is one component of feasibility. Intervention fidelity will be subjectively determined by adherence to group discussion guides that are paired with the video-based intervention component. Data sources will include video recordings of the group discussion and investigator study notes.

    Day 1 and Day 2 - separated by one week

Secondary Outcomes (5)

  • Momentary affective state

    Day 1 and Day 2 - separated by one week

  • Working memory

    Day 1 and Day 2 - separated by one week

  • Heart rate variability

    Day 1 and Day 2 - separated by one week

  • Skin conductance activity

    Day 1 and Day 2 - separated by one week

  • Quality of social communication

    Day 1 and Day 2 - separated by one week

Study Arms (2)

MCI/Mild Dementia

EXPERIMENTAL

Twenty participants will be allocated to this arm if they demonstrate mild impairments in cognition based on a cognitive screening phase. Participants enrolled in this arm will be arranged in groups of 5. They will attend a paperwork visit and two video-viewing sessions (order is randomized) held approximately one week apart: (1) brief immersive nature-based video experience + group discussion and (2) comparison condition that includes presentation of a relatively "neutral," un-arousing documentary + group discussion. Each video lasts approximately 15 minutes. Using a semi-structured group discussion guide, participants will be prompted to talk about what they saw in the video and relate video content to their own lives and experiences.

Other: Immersive Nature VideoOther: Neutral Video

Healthy Older Adults

ACTIVE COMPARATOR

Participants are allocated to this arm if they demonstrate healthy cognition based on a cognitive screening phase. Participants enrolled in this arm will be arranged in groups of 5. They will attend a paperwork visit and two video-viewing sessions (order is randomized) held approximately one week apart: (1) brief immersive nature-based video experience + group discussion and (2) comparison condition that includes presentation of a relatively "neutral," un-arousing documentary + group discussion. Each video lasts approximately 15 minutes. Using a semi-structured group discussion guide, participants will be prompted to talk about what they saw in the video and relate video content to their own lives and experiences.

Other: Immersive Nature VideoOther: Neutral Video

Interventions

An approximately 15-minute digital nature experience using work by filmmaker Louie Schwartzberg-Visual Healing by Moving Art. Time-lapse, high-speed, and macro cinematography are incorporated within each video. Audiovisual content include vivid imagery of a variety of ecosystems and climates accompanied by calming instrumental music. Both the MCI/Mild dementia arm and the healthy older adult arm will experience this intervention.

Healthy Older AdultsMCI/Mild Dementia

This video will include clips from relatively non-arousing educational documentaries. Fifteen minutes of documentary content will be selected from a longer video, ensuring that the content remains as neutral as possible. Video selections were modeled after the work from Eryilmaz, Van De Ville, Schwartz, and Vuilleumier (2011) who identified very brief movie clips (i.e., \<1 minute) that were rated as neutral as opposed to frightful or enjoyable. Both the MCI/Mild dementia arm and the healthy older adult arm will experience this intervention.

Healthy Older AdultsMCI/Mild Dementia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Speaks and understands English
  • Mild cognitive impairment/mild dementia or normal cognition
  • Minor complaints with thinking or memory
  • Demonstrate the cognitive capacity to understand and consent to research procedures and to communicate his/her decision

You may not qualify if:

  • Self-reported phobias that could be triggered by nature-based videos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Front Porch Center for Innovation and Wellbeing

Glendale, California, 91203, United States

Location

University of Southern California

Los Angeles, California, 90089-9003, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Research

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 26, 2018

Study Start

January 14, 2019

Primary Completion

October 1, 2019

Study Completion

February 3, 2022

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations