Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871386
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2021-01-28
Brief Title:
Stayhealthy - Monitoring and Maintenance of Mental Health Under Conditions of Social Isolation During the Corona Crisis
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Stayhealthy - Monitoring Und Erhalt Der Psychischen Gesundheit Unter Bedingungen Sozialer Isolation während Der Corona-Krise
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
stayhealthy
Brief Summary:
The COVID-19 pandemic has led to a global health crisis with so far over 21 million registered cases and more than 700000 deaths worldwide In order to slow down the rate of new infections millions of people have been directed to stay at home thereby accepting severe restrictions of social contact and personal freedom to move With fear of infection and economical loss as additional burdens the current conditions have led to a significant increase in psychological distress and risk for the onset of mental disorders among the general population Empirical evidence on effective measures to support mental health in COVID-19 homestayers is lacking
In the present study the investigators therefore used a randomized controlled trial RCT design to investigate the effects of two online intervention programs derived either from the field of positive psychology PP or acceptance and commitment therapy ACT with a third group of participants writing an online diary only control group Furthermore over the entire study period individual daily coping strategies were collected A total of 138 adult German homestayers participated in the RCT with two weeks of daily interventions during the first lock-down period in Germany April 19th to May 3rd 2020 Measures of stress mental health depression anxiety and subjective well-being subjective vitality overall well-being were collected at baseline at the end of the two-week intervention period and another 14 days after that follow-up
In the present study the investigators therefore used a randomized controlled trial RCT design to investigate the effects of two online intervention programs derived either from the field of positive psychology PP or acceptance and commitment therapy ACT with a third group of participants writing an online diary only control group Furthermore over the entire study period individual daily coping strategies were collected A total of 138 adult German homestayers participated in the RCT with two weeks of daily interventions during the first lock-down period in Germany April 19th to May 3rd 2020 Measures of stress mental health depression anxiety and subjective well-being subjective vitality overall well-being were collected at baseline at the end of the two-week intervention period and another 14 days after that follow-up
Detailed Description:
A total of 138 individuals - recruited via university-wide emails and social media - completed the baseline questionnaire and agreed to participate in the study Inclusion criteria were an age between 18 and 70 years knowledge of the German language as well as conditions of increased social isolation at the beginning of the study The latter criterion was operationalized by only including individuals who were currently staying mostly at home due to the Corona crisis home office quarantine measures stay-at-home orders with no or only very few direct contacts outside of their own household The only relevant exclusion criterion was an acute diagnosis within the last 3 months of a mental disorder by a medical professional
Procedure A link in the invitation email of the study led to the online platform SoSciSurvey where participants received information about the study standards of data security gave informed consent to participate and filled out pre-measures t1 Upon completion all participants who met the inclusion criteria were randomly assigned to one of three groups ACT PP control group and received their personal login credentials to the online platform Synergetic Navigation System SNS ccsysde Version 3754 36 37-39 which was used to administer daily questionnaires and intervention programs In order to keep the changing societal situation constant for all participants the study protocol started on April 19th 2020 for all three groups For a period of 14 days the two intervention groups received a daily prompt at 6 AM via email that their exercise of the day was accessible in the SNS In order to read the exercise instructions participants had to log into their account via app or web browser Every day a new exercise appeared in the system The intervention period with daily email prompts ended after 14 days
In the evening at 530 PM all three groups received an email notification to fill in their daily review questionnaire online diary every day over the entire study period of 28 days On day 14 all participants received an email notification to fill in the post measures t2 available in their SNS account On day 28 all participants received a notification to fill in the follow-up measures t3
Questionnaires and testing material
At t1 baseline assessment participants were asked for information regarding general demographics their personal living situation social situation and current status of health Moreover participants were asked to indicate the influence of the Corona crisis on their personal lives as well as the adequacy of political measures taken to meet the Corona crisis on visual analogue scales 1 not at all - 100 very much
The following outcome measures were assessed to evaluate the impact of the time spent in relative isolation under conditions of increased stress due to the Corona crisis and potential buffering effects of the interventions General stress level was assessed using the German version of the stress module of the patient health questionnaire PHQ-D as a measure of depression we used the nine items of the depression module of the patient health questionnaire PHQ-9 anxiety over the last two weeks was assessed using the 10-item German short version of the State-Trait-Anxiety Inventory trait version referenced to the last two weeks additionally five items measuring participants general subjective vitality were included to measure the influence of social distancing on a dynamic feeling of energy and psychosomatic well-being overall well-being was assessed using five items of the World Health Organization Well-being Index WHO-5
Online diary and assessment of coping strategies All participants received a daily review questionnaire which contained two open questions instructing participants to write down 1 relevant events during the day and 2 things that had helped them in coping positively with the current situation Participants from the intervention groups were also asked to indicate whether they had carried out the intervention that day yesno
Interventions see Interventions section
Procedure A link in the invitation email of the study led to the online platform SoSciSurvey where participants received information about the study standards of data security gave informed consent to participate and filled out pre-measures t1 Upon completion all participants who met the inclusion criteria were randomly assigned to one of three groups ACT PP control group and received their personal login credentials to the online platform Synergetic Navigation System SNS ccsysde Version 3754 36 37-39 which was used to administer daily questionnaires and intervention programs In order to keep the changing societal situation constant for all participants the study protocol started on April 19th 2020 for all three groups For a period of 14 days the two intervention groups received a daily prompt at 6 AM via email that their exercise of the day was accessible in the SNS In order to read the exercise instructions participants had to log into their account via app or web browser Every day a new exercise appeared in the system The intervention period with daily email prompts ended after 14 days
In the evening at 530 PM all three groups received an email notification to fill in their daily review questionnaire online diary every day over the entire study period of 28 days On day 14 all participants received an email notification to fill in the post measures t2 available in their SNS account On day 28 all participants received a notification to fill in the follow-up measures t3
Questionnaires and testing material
At t1 baseline assessment participants were asked for information regarding general demographics their personal living situation social situation and current status of health Moreover participants were asked to indicate the influence of the Corona crisis on their personal lives as well as the adequacy of political measures taken to meet the Corona crisis on visual analogue scales 1 not at all - 100 very much
The following outcome measures were assessed to evaluate the impact of the time spent in relative isolation under conditions of increased stress due to the Corona crisis and potential buffering effects of the interventions General stress level was assessed using the German version of the stress module of the patient health questionnaire PHQ-D as a measure of depression we used the nine items of the depression module of the patient health questionnaire PHQ-9 anxiety over the last two weeks was assessed using the 10-item German short version of the State-Trait-Anxiety Inventory trait version referenced to the last two weeks additionally five items measuring participants general subjective vitality were included to measure the influence of social distancing on a dynamic feeling of energy and psychosomatic well-being overall well-being was assessed using five items of the World Health Organization Well-being Index WHO-5
Online diary and assessment of coping strategies All participants received a daily review questionnaire which contained two open questions instructing participants to write down 1 relevant events during the day and 2 things that had helped them in coping positively with the current situation Participants from the intervention groups were also asked to indicate whether they had carried out the intervention that day yesno
Interventions see Interventions section
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None