An interventional study of Immersive Nature Video and Neutral Video in Mild Dementia and Mild Cognitive Impairment, sponsored by University of Southern California. Terminated at 2 sites in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 25 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
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Exclusion Criteria:
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 Video · Other: Neutral Video
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 Video · Other: Neutral Video
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 and Day 2 - separated by one week
Momentary affective state
Participants' acute affective state will be assessed using the Multidimensional Mood Questionnaire (MDMQ) - English translation (Steyer, Schwenkmezger, Notz, \& Eid, 1994). This 24-item questionnaire addresses degrees of unpleasantness, sleepiness, and restlessness. Items are rated on a 5-point Likert scale ranging from "not at all" to "very much." Subscale items are summed, with higher scores indicated greater well-being.
Time frame: Day 1 and Day 2 - separated by one week
Working memory
Working memory will be assessed using a single 2-back test (visual only) administered using a tablet application. In this task, participants will be presented with a digit (0 - 9) that they must temporarily memorize and then indicate if a future stimulus is the same as that digit presented 1 trial previously.
Time frame: Day 1 and Day 2 - separated by one week
Heart rate variability
Heart rate will be defined using blood volume pulse signal captured by the E4 empatica wrist monitor.
Time frame: Day 1 and Day 2 - separated by one week
Skin conductance activity
Stress/excitement will be defined using skin conductivity changes captured by the E4 empatica wrist monitor.
Time frame: Day 1 and Day 2 - separated by one week
Quality of social communication
Video recordings of group discussions will be made to capture social behaviors including communication and interaction. Recordings will subsequently be analyzed using the Holden Communication Scale (Holden \& Woods, 1995). This 12-item instrument that addresses factors including conversation, awareness, pleasure, humor, and responsiveness, will be completed by research personnel who will watch and analyze video recordings of each session. Higher scores indicate more impairment with social behavior. The Holden Communication Scale has been determined a valid and reliable assessment for communication ability in persons with dementia (Strøm, Engedal, Benth, \& Grov, 2016).
Time frame: Day 1 and Day 2 - separated by one week
Plan to share: Undecided
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