Clinical trial NCT04036565: The Sunlight Exposure Therapy on the Improvement of Depression and Quality of Life in Post-stroke Patients
Official title: The Sunlight Improves Depression in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Depression
Keywords: Sunlight
depression
daily active function
stroke
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-07-29
Enrollment: 46
Sex: ALL
Minimum age (years): 24
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants had to be verified one-month post-stroke patients in stable condition, with an NIHSS score of not more than 15 (minor or moderate stroke).

Brief summary: Chronic diseases has been the leading causes of death in 2015 to 2017 based on the National database. In particular, cerebrovascular disease was the third in 2015, the fourth in 2016 and 2017. In the Statistical Office of the Ministry of Health and Welfare (2016, 2017,2018). Previous studies have suggested that nearly 30% of the stroke victims present with signs of depression within the first 5 years of illness. Since post-stroke depression significantly affects the patient both physically and psychologically, the emotional disturbances impede the progress and effectiveness of rehabilitation. Regarding the non-pharmacological treatment of melancholia, the phototherapy has been used to treat psychological, behavioral or emotional disorders with satisfactory outcomes.Furthermore, many studies has suggested that artificial light should mimic natural sunlight to reach optimal effect. The benefit of sunlight in human wellbeing has been well documented, therefore we intend to utilize sunlight therapy for stroke patients in order to improve their physical and mental health.

Detailed description: This study is an experimental interventional study for two groups with pretest and posttest analysis. The subjects of the study met the inclusion criteria and were recruited by intention sampling method. They were randomly assigned to the experimental group and the control groups. This is a single-blind study with sunlight exposure as intervention. Appropriate clothing, skin protection measures were given. The calf portion of feet, forearms and hands were exposed to sunlight for at least 30 minutes per day, at least 14 days of exposure with intensity at least 10000lux over duration of 4 weeks. A total of 46 patients were recruited and 4 have lost follow up. 21 patients from each group have completed the study. The research tools include: depression status (Taiwanese depression scale,TDS), physical activity function (Barthel Index), the severity of cognitive function (mini-mental state examination,MMSE) and severity of stroke (National institutes of health stroke scale,NIHSS). Each patient was evaluated 3 times during the study: on the day of enrollment (pre-test), 2 to 4 weeks since enrollment (1st post-test) and 6-8 weeks after enrollment (2nd post-test). Statistical analysis was performed with the following variables: depression, cognitive function (MMSE), severity of stroke (NIHSS) and the Barthel Index for daily function.

The participants in the experimental and control groups were subjected to a pre-test measurement after they were recruited. For the experimental group, the first post-test measurements were taken right after the participants completed the sunlight therapy (two to four weeks after the start of the intervention), and the second post-test measurements were taken one month after the intervention was completed (six to eight weeks after the start of the intervention). For the control group, the first and second post-test measurements were taken two and six weeks, respectively, after they started receiving standard care.

At the start of intervention, the researchers conducting this study instructed the experimental group to fill out a sunshine exposure duration record sheet. The participants used symbols on the record sheet to indicate the day's weather, such as sunny, partly sunny, and cloudy and rainy. Sunshine records were excluded on cloudy and rainy days, while records were taken on partly sunny days with sufficient sunshine, and participants had to expose themselves outdoors to the sun in an outdoor environment; they were not allowed to expose themselves to the sun from an indoor environment through glass. Participants had to take appropriate protective measures on their own beforehand, such as wearing breathable clothing, visors or sunglasses, and applying sunblock. Throughout the implementation of the sunlight therapy, participants were allowed to rest and drink in shady areas if they had any discomforts (dizziness, hyperthermia), so as to avoid overexposure to sunlight. If they had a burning skin sensation or itchy skin, they were allowed to rinse their skin with cold water, iced water, or ice cubes, or to apply ice cubes on their skin for three to five minutes, so as to lower their skin temperature and alleviate skin allergies. They were advised to call for a medical examination or to contact the researchers if their symptoms persisted.

Eligibility criteria: Inclusion Criteria:

* Participants also had to meet at least two of the Diagnostic and Statistical Manual(DSM)-IV diagnosis criteria for minor depression, dejection, or dysthymia, and had to be conscious and capable of expressing themselves. Participants had to be aged 20 or above, able to converse in or be literate in Mandarin or Taiwanese, and agree, after being asked to provide consent, to participate in this study.

Exclusion Criteria:

* Patients with a NIHSS score higher than 16 (severe stroke); patients with stroke caused by cancer metastasis; stroke patients with cancer comorbidity; and patients who were on dialysis, pregnant, mentally-challenged, or suffering from severe cognitive disabilities.

Primary outcomes:
measure: depression status (Taiwanese depression scale, TDS)
timeFrame: 8-12weeks
measure: physical activity function (Barthel Index)
timeFrame: 8-12weeks
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 8-12weeks
Other outcomes:
measure: cognitive status (mini-mental state examination,MMSE).
timeFrame: 8-12weeks
Locations:
city: Taipei
country: Taiwan
facility: Su-Jen Wang
Study officials:
affiliation: School of Nursing, National Taipei University of Nursing and Health Sciences.
name: Miao-Yen Chen
role: STUDY_DIRECTOR
References:
citation: West A, Jennum P, Simonsen SA, Sander B, Pavlova M, Iversen HK. Impact of naturalistic lighting on hospitalized stroke patients in a rehabilitation unit: Design and measurement. Chronobiol Int. 2017;34(6):687-697. doi: 10.1080/07420528.2017.1314300. Epub 2017 Apr 21.