Clinical trial NCT05220592: Learning How to Recover From Stress - Pilot RCT
Official title: Learning How to Recover From Stress: Results From an Internet-based Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Disorders
Keywords: Recovery
Stress
Internet-based
Prevention
Intervention
Work
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2022-02-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a two-armed controlled trial in which an internet-based recovery training program (iRTP) was compared with a wait-list control group (WLC). The study followed Consolidated Standards of Reporting Trials (CONSORT) guidelines (Schulz et al., 2010) and was conducted between February 2018 and May 2019. Since this was a pilot trial, no power calculation and estimates of sample size were conducted.
Primary purpose: PREVENTION

Brief summary: This randomized, controlled pilot trial evaluated the efficacy of a brief internet-based recovery training intervention targeting distressed employees. This pilot trial is one of the first to examine a brief recovery training program's efficacy, suggesting that employees across a wide range of professions could learn how to recover from elevated stress symptoms. This type of accessible and brief recovery intervention might shape the future of stress prevention, but more research is needed with larger samples before further conclusions can be drawn.

Detailed description: In recent years, work-related stress and burnout have received more attention, with a higher prevalence observed within the working population. Today, every fourth employee has experienced stress during most of their working days. Employees exposed to prolonged stress in their work situations experience more strain and suffer from poor well-being; higher risk of severe health implications, such as coronary artery disease; and problems in work participation, such as sickness absences, including long-term sick leave.

Empirical research suggests that recovery from work is important in reducing the negative effects on employees from stress and strain, as well as preserving their well-being and work performance. Recovery refers to the restoration processes during which a person's stress level returns to its pre-stress level. Recovery as a process refers to the activities and experiences that elicit change in stress and strain indicators. Recovery as an outcome captures a person's psychological or physiological state reached after a recovery period (e.g., at the end of a workday). Confirmatory factor analysis has proposed four distinct experiences in recovering from work processes: psychological detachment; relaxation; mastery; and control. Extant studies confirm that these experiences are related positively to well-being indicators such as the Recovery Experience Questionnaire.

Although extensive research has been devoted to stress intervention programs, and evidence suggest that these are effective in reducing stress within the working population, few studies have evaluated interventions aimed at stress prevention, e.g., by removing stressors and/or enhancing well-being factors, such as recovery. Most stress interventions have focused on reducing participants' cognitive, emotional, and behavioral symptoms when coping with stress. However, some promising results on stress prevention have been observed from recovery training programs.

Despite the evidence on the efficacy of stress management interventions and some promising results from recovery training interventions , only a small percentage of distressed employees actually receive stress interventions. This calls for further development and evaluation of interventions that are accessible and has the potential in preventing chronic stress in the working population.

The internet has the potential to disseminate interventions broadly, and a growing body of literature has demonstrated internet-based stress interventions' efficacy, with small to moderate effects on outcomes from stress, burnout, insomnia, depression, and anxiety.

The present, controlled pilot study aim to examine the efficacy of a brief, five-week, internet-based recovery training program for employees experiencing elevated symptoms of stress and/or a stress-related disorder burnout in a randomized, controlled pilot trial. We hypothesize that the internet-based recovery program would produce greater improvements in recovery experiences (primary outcome) compared with a wait-list control group. We also hypothesize that the intervention group will differ with regard to important health-related (perceived stress, burnout, exhaustion, depression, alcohol consumption, and quality of life) and work-related (work experience, work ability, sickness absences) outcomes. Finally, we investigate whether the initially achieved changes in the intervention group would remain stable at six- and 12-month follow-ups.

Eligibility criteria: Inclusion Criteria:

All participants were volunteers. To be eligible for the study, each participant had to fulfill the following criteria:

* at least 18 years old; (ii) fluent in Swedish
* have access to a computer or handheld device with internet access
* currently be employed
* \>14 points on the Perceived Stress Scale
* \<5 points on the Shirom Melamed Burnout Questionnaire (SMBQ)
* \<20 points on the Montgomery Åsberg Depression Rating Scale-Self-Rated (MADRS-S)
* \<21 points on the Insomnia Severity Index (ISI)
* \<14 points on the Alcohol Use Disorders Identification Test (AUDIT).

Exclusion Criteria:

Participants were excluded from the study if they:

* currently were in treatment for stress or burnout;
* currently were suffering from bipolar disorder, psychosis, post-traumatic stress disorder (PTSD), eating disorders, substance abuse, severe forms of depression, anxiety disorder or personality disorders as assessed in a telephone interview (MINI)
* suicidal ideation based on Item 9 on the MADRS-S.
* If on medication (e.g., antidepressants or sleep medication) this should be held constant medication constant during the study period.

Primary outcomes:
measure: Recovery Experiences Questionnaire
timeFrame: Pre; 5 weeks
Secondary outcomes:
measure: Shirom-Melamed Burnout Questionnaire
timeFrame: Pre; 5 weeks
measure: Perceived Stress Scale
timeFrame: Pre; 5 weeks
measure: Karolinska Exhaustion Disorder Scale
timeFrame: Pre; 5 weeks
measure: Montgomery Åsberg Depression Rating Scale
timeFrame: Pre; 5 weeks
measure: Generalised Anxiety Disorder Scale
timeFrame: Pre; 5 weeks
measure: Insomnia Severity Index
timeFrame: Pre; 5 weeks
measure: Alcohol Use Disorders Identification Test
timeFrame: Pre; 5 weeks
measure: Work Experience Measurement Scale
timeFrame: Pre; 5 weeks
measure: Work Ability Index
timeFrame: Pre; 5 weeks
measure: International Physical Activity Questionnaire
timeFrame: Pre; 5 weeks
measure: Brunnsviken Brief Quality of Life Inventory
timeFrame: Pre; 5 weeks
measure: Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry
timeFrame: Pre; 6 months
Other outcomes:
measure: Recovery Experiences Questionnaire
timeFrame: 6-month, 12-month
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: