Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
A Single Center Pilot Study to Evaluate Real Time Passive and Active High-Frequency Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
연구 개요
상세 설명
The novel method being tested in this study for assessing mood and cognition in participants with MDD was wearable technology. This study looked at the correlation of mood and cognition outcomes on wearable technology with traditional objective neuropsychological cognitive function tests and self-reported mood outcomes.
The study enrolled approximately 30 patients. Participants were provided with a watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
All participants prompted to complete cognitive and mood assessments on 3 occasions across the day. Two occasions (morning and afternoon) comprised assessment of cognition, and the final assessment in the evening constituted a review of the day focusing on self-reported depressed mood.
This single-center trial was conducted in United Kingdom. The overall time to participate in this study was 6 weeks. Participants took part up to 5 study visits (1 in-person on-site visit, 3 web-based and 1 at home visit) assessing performance on traditional objective neuropsychological cognitive function tests and self-reported measures of depression symptom severity and social function.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
London, 영국
- Takeda Investigative Site
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Has MDD as the primary psychiatric diagnosis.
- Has been treated previously with at least 1 antidepressant (monotherapy).
- Has scores on Participant Health Questionnaire-9 items (PHQ-9) ≥5 and PHQ-9 ≤15 at Screening
Exclusion Criteria:
- Has a significant risk of suicide according to the investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening.
- Has a history of only responding to either combination or augmentation therapy in the current episode and has had been treated for more than a year without any period of remission.
Has 1 or more of the following:
- Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Participants With Major Depressive Disorder (MDD)
Participants with MDD were provided with an Apple watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks.
|
개입 없음
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Days on Which Daily N-back Sessions Were Completed
기간: Baseline up to Week 6
|
The cognitive assessment n-back test was completed on the wearable technology (Apple watch) on 3 occasions across the day in the morning, afternoon and evening.
|
Baseline up to Week 6
|
|
Percentage of Days on Which Daily Mood Assessment Tests Were Completed
기간: Baseline up to Week 6
|
The Daily Mood assessments were completed on the wearable technology (Apple watch) once per day in the afternoon or evening.
|
Baseline up to Week 6
|
|
Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) Tests: Spatial Working Memory Between Errors (SWMBE) and Spatial Working Memory Strategy (SWMS)
기간: Baseline up to Week 6
|
The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated. CANTAB tests consists of a battery of neuropsychological tests. Spatial Working Memory (SWM) assessed retention of spatial data, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. SWMBE=cumulative number of times participant went back to box that a token was previously removed per each successful study. Lower score was better. SWMS=number of unique boxes participant searched in two 6 and 8 box trials. Total of 4 trial scores ranged from 4-28. Lower score indicated better performance. Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided as a value +1=positive correlation to -1=negative correlation. 0=no correlation. |
Baseline up to Week 6
|
|
Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP)
기간: Baseline up to Week 6
|
The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated. CANTAB tests consists of a battery of neuropsychological tests. RVP measures sustained attention. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits. RVPA=measure of sensitivity to the target, regardless of response tendency (expected range is 0.00 to 1.00). Speed of Processing (RVPMDL)=The mean response latency during assessment sequence blocks where the participant responded correctly. Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided a value +1=positive correlation to -1=negative correlation. 0=no correlation. |
Baseline up to Week 6
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
개입 없음에 대한 임상 시험
-
Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
-
Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로
-
Guangzhou Women and Children's Medical Center아직 모집하지 않음NEC - 괴사성 장염
-
Monash UniversityThe Alfred; Melbourne Sexual Health Centre모병매독중국, 호주, 남아프리카, 영국
-
IRCCS San Raffaele모집하지 않고 적극적으로