NCT04871386: stayhealthy

#Stayhealthy - Monitoring and Maintenance of Mental Health Under Conditions of Social Isolation During the Corona Crisis

Completed NA Last updated 4 May 2021

What this trial tests

NA trial testing Acceptance and commitment therapy (ACT) exercises in Mental Health Wellness 1 in 138 participants. Completed in 18 May 2020.

Timeline

15 April 2020

Primary endpoint
18 May 2020

18 May 2020

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	138
Start date	15 April 2020
Primary completion	18 May 2020
Estimated completion	18 May 2020
Sites	1 location across Germany

Drugs / interventions tested

• Acceptance and commitment therapy (ACT) exercises
• Positive psychology (PP) exercises

Conditions studied

• Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →

Sponsor

University Hospital Tuebingen

Who can join

Adults 18 to 70, any sex, with Mental Health Wellness 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID 19 pandemic challenges and their management: A review of medicines, vaccines, patents and clinical trials with emphasis on psychological health issues.
   Mohapatra S, Ayash Kumar P, Farooq U, Jain P, et al · · 2022 · cited 3× · PMID 35645588 · DOI 10.1016/j.jsps.2022.05.004
2. Move, connect and go outside! A randomized controlled trial of two online interventions and analysis of helpful coping strategies in COVID-19 "homestayers".
   Ehlis AC, Aas B, Kieckhäfer C, Schiepek G, et al · · 2025 · cited 1× · PMID 39414371 · DOI 10.1111/aphw.12603
3. The Impact of Government Lockdowns on the Mental Health of the General Population: A Systematic Review and Meta-analysis.
   Okazaki Y, Tsujimoto Y, Yamada K, Saka N, et al · · 2025 · PMID 40453305 · DOI 10.7759/cureus.83249