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

NCT04871386 | Completed

• 1 other identifier: 228/2020BO2
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

anxiety; stress; depression; COVID-19; Corona virus

Outcome Measures

Primary Outcomes (10)

• General stress level (change from baseline/day 1 to post-measurement/day 14)

  General stress level was assessed using the German version of the stress module of the patient health questionnaire (PHQ-). It measures the degree of impairment (not at all, a little, very much; 0-2) in the past four weeks due to nine different sources of stress (assessed by 10 items), such as health worries (item 1), stress due to care issues for family members (item 5), stress at work or in school (item 6), financial concerns (item 7) or having nobody to talk (item 8).

  change from baseline/day 1 to post-measurement/day 14

• General stress level (change from post-measurement/day 14 to follow-up/day 28)

  General stress level was assessed using the German version of the stress module of the patient health questionnaire (PHQ-). It measures the degree of impairment (not at all, a little, very much; 0-2) in the past four weeks due to nine different sources of stress (assessed by 10 items), such as health worries (item 1), stress due to care issues for family members (item 5), stress at work or in school (item 6), financial concerns (item 7) or having nobody to talk (item 8).

  change from post-measurement/day 14 to follow-up/day 28

• Symptoms of depression (change from baseline/day 1 to post-measurement/day 14)

  As a measure of depression, we used the nine items of the depression module of the patient health questionnaire (PHQ-9). The instrument assesses impairment (not at all, on some days, more than half of the days, almost every day; 0-3) due to symptoms such as loss of interest and joy in one's activities (item 1) or fatigue and low energy (item 4) over the last two weeks.

  change from baseline/day 1 to post-measurement/day 14

• Symptoms of depression (change from post-measurement/day 14 to follow-up/day 28)

  As a measure of depression, we used the nine items of the depression module of the patient health questionnaire (PHQ-9). The instrument assesses impairment (not at all, on some days, more than half of the days, almost every day; 0-3) due to symptoms such as loss of interest and joy in one's activities (item 1) or fatigue and low energy (item 4) over the last two weeks.

  change from post-measurement/day 14 to follow-up/day 28

• Anxiety (change from baseline/day 1 to post-measurement/day 14)

  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). The frequency of feelings of calmness (item 3, reversed), lack of self-confidence (item 6), negative thoughts (item 9), feelings of nervousness and unrest (item 10) etc. were rated on an 8-point scale from "almost never" to "almost always" (1-8; due to technical problems, item 7 is missing from this scale).

  change from baseline/day 1 to post-measurement/day 14

• Anxiety (change from post-measurement/day 14 to follow-up/day 28)

  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). The frequency of feelings of calmness (item 3, reversed), lack of self-confidence (item 6), negative thoughts (item 9), feelings of nervousness and unrest (item 10) etc. were rated on an 8-point scale from "almost never" to "almost always" (1-8; due to technical problems, item 7 is missing from this scale).

  change from post-measurement/day 14 to follow-up/day 28

• Subjective vitality (change from baseline/day 1 to post-measurement/day 14)

  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. Participants rated their agreement to statements regarding their general feelings of vitality and aliveness on a 7-point Likert scale from "not at all" to "a lot" (1-7).

  change from baseline/day 1 to post-measurement/day 14

• Subjective vitality (change from post-measurement/day 14 to follow-up/day 28)

  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. Participants rated their agreement to statements regarding their general feelings of vitality and aliveness on a 7-point Likert scale from "not at all" to "a lot" (1-7).

  change from post-measurement/day 14 to follow-up/day 28

• Overall well-being (change from baseline/day 1 to post-measurement/day 14)

  Overall well-being was assessed using five items of the World Health Organization Well-being Index (WHO-5). Participants needed to determine on a 6-point Likert scale to what extent the items regarding the person's happy mood, calmness, feelings of energy, feelings of recovery in the morning and interest in daily activities had applied during the last two weeks (at no point in time - all the time; 0-5).

  change from baseline/day 1 to post-measurement/day 14

• Overall well-being (change from post-measurement/day 14 to follow-up/day 28)

  Overall well-being was assessed using five items of the World Health Organization Well-being Index (WHO-5). Participants needed to determine on a 6-point Likert scale to what extent the items regarding the person's happy mood, calmness, feelings of energy, feelings of recovery in the morning and interest in daily activities had applied during the last two weeks (at no point in time - all the time; 0-5).

  change from post-measurement/day 14 to follow-up/day 28

Secondary Outcomes (2)

• Coping strategies

  Daily for 14 consecutive days

• Daily questionnaire

  Daily for 14 consecutive days

Study Arms (3)

Acceptance and commitment therapy (ACT)

EXPERIMENTAL

14 consecutive days of exercises (prompted via email every morning) derived from acceptance and commitment therapy (ACT); the instructions were text-based, contained a brief introduction to the general goal and the exercise of the day; the exercises were designed to be completable individually in 20 minutes. Additionally: completion of a daily review questionnaire ("online diary") including two open questions (Relevant events during the day? Helpful things for coping positively with the current situation?)

Behavioral: Acceptance and commitment therapy (ACT) exercises

Positive psychology intervention (PP)

EXPERIMENTAL

14 consecutive days of exercises (prompted via email every morning) derived from positive psychology (PP) interventions; the instructions were text-based, contained a brief introduction to the general goal and the exercise of the day; the exercises were designed to be completable individually in 20 minutes. Additionally: completion of a daily review questionnaire ("online diary") including two open questions (Relevant events during the day? Helpful things for coping positively with the current situation?)

Behavioral: Positive psychology (PP) exercises

Control group

NO INTERVENTION

completion of a daily review questionnaire ("online diary") including two open questions (Relevant events during the day? Helpful things for coping positively with the current situation?); no additional intervention

Interventions

Acceptance and commitment therapy (ACT) exercises BEHAVIORAL

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.

Acceptance and commitment therapy (ACT)

Positive psychology (PP) exercises BEHAVIORAL

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.

Positive psychology intervention (PP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• knowledge of the German language
• conditions of increased social isolation at the beginning of the study (only individuals were included 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)

You may not qualify if:

• acute diagnosis (within the last 3 months) of a mental disorder by a medical professional

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; COVID-19

Interventions

Exercise; Psychology, Positive

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychology; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Ann-Christine Ehlis, PhD

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: May 4, 2021
• Study Start: April 15, 2020
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-01

Locations

DE (1)