StrokeNCT04036565
The Sunlight Exposure Therapy on the Improvement of Depression and Quality of Life in Post-stroke Patients
An observational study of Stroke and Depression, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 24 to 85 years
- Conditions the study is for
- Stroke, Depression
- What is being tested?
- sunlight therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Oct 2017to 23 Apr 2018
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sunlight Improves Depression in Stroke Patients
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.
Read the 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.
- Conditions
- Stroke, Depression
- Being tested
- sunlight therapy
- Keywords
- Sunlight, depression, daily active function, stroke
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunlight therapyBehavioural
Exposed to sunlight for at least 30 minutes per day, at least 14 days of exposure duration of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: sunlight therapy | |
| The control group | Standard care.The first and second post-test measurements were taken two and six weeks, respectively, after they started receiving standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression status (Taiwanese depression scale, TDS)
change depression status. Assess the feeling of body and mood within 7 days. Those who are above 19 will be considered as those with severe depression. 15-18 is divided into depression points to the critical point. 9-14 is divided into emotional ups and downs.
Measured: 8-12weeks
physical activity function (Barthel Index)
improved physical activity function. The total score of the scale is between 0 to 100 points. The higher the score, the better the activity Can be re-evaluated at different times, compare the difference in scores to determine whether daily life function is progressing or regressing
Measured: 8-12weeks
Secondary outcomes (1)
National Institute of Health Stroke Scale (NIHSS)
change stroke severity. The total score of the scale is between 0 to 38 points stroke severity was categorized as minor (NIHSS = 0 to 6), moderate (NIHSS = 7 to 15), and severe (NIHSS = 16 to 38)
Measured: 8-12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start9 Oct 2017
- Primary completion23 Apr 2018
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Miao-Yen Chen, Study director, School of Nursing, National Taipei University of Nursing and Health Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036565
- Sponsor's protocol ID
- 2017-09-001CC
- Status last verified
- Aug 2019
- First submitted
- 26 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sunlight therapy intervention: The sun had to be bright and visible during the day, with an illuminance of 10,000 lux and above (Chang et al., 2011). Participants were required to employ appropriate protective measures when directly exposing their forearms or calves under the sun for an accumulated minimum of 30 minutes per day, for a total of 14 days in four weeks.
Publications
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.
PubMed 28430522
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sunlight Improves Depression in Stroke Patients
- ClinicalTrials.gov ID
- NCT04036565
- Acronym / sponsor ID
- 2017-09-001CC
- Conditions
- Stroke, Depression
- Keywords
- Sunlight, depression, daily active function, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | – | Behavioral: sunlight therapyThe 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). |
| The control group | – | –Standard care.The first and second post-test measurements were taken two and six weeks, respectively, after they started receiving standard care. |
Who may qualify
- Ages
- 24 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunlight therapyExposed to sunlight for at least 30 minutes per day, at least 14 days of exposure duration of 4 weeks. | Behavioural | The experimental group |
Primary outcome
depression status (Taiwanese depression scale, TDS)
Time frame: 8-12weeks
change depression status. Assess the feeling of body and mood within 7 days. Those who are above 19 will be considered as those with severe depression. 15-18 is divided into depression points to the critical point. 9-14 is divided into emotional ups and downs.
physical activity function (Barthel Index)
Time frame: 8-12weeks
improved physical activity function. The total score of the scale is between 0 to 100 points. The higher the score, the better the activity Can be re-evaluated at different times, compare the difference in scores to determine whether daily life function is progressing or regressing
1 secondary outcome
National Institute of Health Stroke Scale (NIHSS)
Time frame: 8-12weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Results publication: PubMed 28430522West 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.
- Individual participant dataSharing planned: Undecided. Sunlight therapy intervention: The sun had to be bright and visible during the day, with an illuminance of 10,000 lux and above (Chang et al., 2011). Participants were required to employ appropriate protective measures when directly exposing their forearms or calves under the sun for an accumulated minimum of 30 minutes per day, for a total of 14 days in four weeks.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miao-Yen Chen study director
School of Nursing, National Taipei University of Nursing and Health Sciences.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Depression, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression status (Taiwanese depression scale, TDS) (time frame: 8-12weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04036565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.