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

NCT04871386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-05-04

No results posted yet for this study

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).

Conditions

  • Mental Health Wellness 1

Interventions

BEHAVIORAL

Acceptance and commitment therapy (ACT) exercises

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.

BEHAVIORAL

Positive psychology (PP) exercises

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.

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Ann-Christine Ehlis, PhD · University Hospital Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2020-05-18
Completion
2020-05-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871386 on ClinicalTrials.gov