#Stayhealthy - Monitoring and Maintenance of Mental Health Under Conditions of Social Isolation During the Corona Crisis
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      The COVID-19 pandemic has led to a global health crisis with, so far, over 21 million
      registered cases and more than 700.000 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).
    

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: ccsys.de, Version 3.7.54; 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 5.30 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 (yes/no).

      Interventions: see Interventions section
    

Intervention name(s): Acceptance and commitment therapy (ACT) exercises; Positive psychology (PP) exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The ACT group received 14 (partially succeeding) daily exercises, with each of the following categories being focused twice: Acceptance, contact with the present moment, cognitive defusion, self as context, personal values and committed action. The exercises consisted of metaphors and questions for self-reflection, explanations about emotions and thoughts with techniques to handle them differently, as well as a body scan.; The PP group received 14 daily exercises that were derived from positive psychology interventions that have been proven effective in alleviating clinical symptoms and increasing subjective well-being. In detail, these were: Identifying positive emotions and ways to increase them; Enhancing pleasure from daily activities; Writing a gratitude letter; Identifying and appreciating three personal traits; Receiving a letter of support from one's future self; Taking different perspectives on one's current situation; Envisioning a perfect day; Identifying energy boosters and drainers; Identifying 3 character strengths and using one in a new way; Life review: Writing a legacy; Identifying the positive relationships in one's life; Doing an act of kindness; Three good things; and Coping with failure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: anxiety; stress; depression; COVID-19; Corona virus