Learning How to Recover From Stress - Pilot RCT

February 1, 2022 updated by: Gerhard Andersson, Linkoeping University

Learning How to Recover From Stress: Results From an Internet-based Randomized Controlled Pilot Trial

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Östergötland
      • Linköping, Östergötland, Sweden, 58183
        • Department of Behavioral Sciences and Learning, Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Internet-based recovery training program (n=35)
The iRTP was based on recovery experiences (psychological detachment, relaxation, mastery, and control), converted into a recovery training intervention inspired by Hahn et al. (2011). The iRTP comprised five modules distributed over five weeks, with modules lasting 60-120 minutes per week.
The iRTP was based on recovery experiences (psychological detachment, relaxation, mastery, and control), converted into a recovery training intervention, and inspired by Hahn et al. (2011). The iRTP comprised five modules distributed over five weeks, with modules lasting 60-120 minutes per week. Each module contained psycho education, worksheets, images, cases, audio and video files, and homework assignments.
NO_INTERVENTION: Wait-list control group (n=34)
Wait-list control group received equal and parallell assessment and eligibility procedure as the experimental conditions. Wait-list control group gained access to iCBT/W-iCBT program after the six months follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Experiences Questionnaire
Time Frame: Pre; 5 weeks
The 16-item Recovery Experience Questionnaire (REQ) includes four factors, representing four different recovery experiences; (i) psychological detachment (ii) relaxation, (iii) mastery and (iv) control. The questionnaire is answered on a 5-point Likert scale, and has been validated in a Swedish population showing excellent internal consistency, α=0.92 [83].
Pre; 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shirom-Melamed Burnout Questionnaire
Time Frame: Pre; 5 weeks
The Shirom-Melamed Burnout Questionnaire (SMBQ), is a 22-item scale (graded 1-7) used to assess different aspects of chronic stress and burnout (Physical Fatigue, Cognitive weariness, Tension, and Listlessness). This scale correlates significantly with other well established questionnaires measuring burnout, e.g., Maslach Burnout Inventory. The SMBQ has an internal consistency reliability (Cronbach's alpha) of .92..
Pre; 5 weeks
Perceived Stress Scale
Time Frame: Pre; 5 weeks
Perceived stress was measured with the 10-item version of the Perceived Stress Scale (PSS-14), translated into Swedish. The PSS-10 is designed to measure the degree to which situations in one's life are appraised as stressful. The Swedish version of PSS has an internal consistency reliability (Cronbach's alpha) of .82 and split-half reliability estimate of .84.
Pre; 5 weeks
Karolinska Exhaustion Disorder Scale
Time Frame: Pre; 5 weeks
Karolinska Exhaustion Disorder Scale (KEDS-9) is a 9-item questionnaire measuring symptoms of chronic stress, fatigue and exhaustion. The instrument is answered on a 7-point scale, with a scale range of 0-54. A cut-off score of 19 was shown to discriminate between healthy subjects and patients with chronic stress and exhaustion. KEDS-9 has satisfactory reliability, Cronbach's alpha of .94.
Pre; 5 weeks
Montgomery Åsberg Depression Rating Scale
Time Frame: Pre; 5 weeks
We used the Montgomery Åsberg Depression Rating Scale self-assessment, MADRS-S to measure symptoms of depression. MADRS-S consists of nine items measuring different symptoms of depression and each symptom is rated on a six-point scale. The instrument has good reliability and has been validated as an internet-based measure. In a comparative study the MADRS-S correlated highly (r = .87) with the Beck Depression Inventory, indicating acceptable convergent validity.
Pre; 5 weeks
Generalised Anxiety Disorder Scale
Time Frame: Pre; 5 weeks
Generalized Anxiety Disorder 7-item Scale (GAD-7) is an instrument assessing excessive worry and generalized anxiety disorder. GAD-7 had good internal consistency reliability (α = .83), test-retest reliability (r = .83), as well as criterion, construct, factorial, and procedural validity. A cut-off score of 10 has been suggested to discriminates between healthy subjects and patients with generalized anxiety disorder.
Pre; 5 weeks
Insomnia Severity Index
Time Frame: Pre; 5 weeks
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that measures individuals perceptions of their insomnia and the severity of problems with delayed sleep onset, sleep maintenance, and early morning awakenings. ISI exhibits adequate internal consistency measures (α =.74), and is a sensitive measure to detect changes in perceived sleep difficulties. It has previously been validated as an internet-based measure.
Pre; 5 weeks
Alcohol Use Disorders Identification Test
Time Frame: Pre; 5 weeks
The Alcohol Use Disorders Identification Test (AUDIT) was used to assess potential alcohol dependence or abuse. In a study of the psychometric properties of the Swedish version of AUDIT, both internal and test-retest reliabilities were satisfactory. A cut-off of <14 points on the AUDIT indicating risk of overconsumption of alcohol.
Pre; 5 weeks
Work Experience Measurement Scale
Time Frame: Pre; 5 weeks
The Work Experience Measurement Scale (WEMS) is an instrument measuring the experience of work from a health resource perspective. WEMS consists of 32 items measuring job satisfaction in five different domains (supportive work conditions, internal work experience, autonomy, time experience, management, process of change) on a six-point scale. Cronbach's alpha on the WEMS has been reported to be in the interval of .85-.96.
Pre; 5 weeks
Work Ability Index
Time Frame: Pre; 5 weeks
Work Ability Index (WAI) is an instrument for assessing health status and work ability among employees. The WAI comprises of different scales, with scores ranging from 7 to 49 points. Studies have suggested that 7-27 points = poor; 28-36 points = moderate; 37-43 points = good; and 44-49 points indicates excellent work ability. Analyses of reliability indicates satisfactory internal consistency, α-levels ranging from .79 to .80.
Pre; 5 weeks
International Physical Activity Questionnaire
Time Frame: Pre; 5 weeks
The International Physical Activity Questionnaire (IPAQ) is a 10-item self-assessment questionnaire (short version) that aims to measure physical activity and inactivity. Participants are asked to rate all their physical activity (according to intensity level, e.g., walking, moderately strenuous activities, and very strenuous activities) and inactivity (i.e., sedentary time) in minutes over the previous seven days. The IPAQ has demonstrated acceptable reliability, test-retest reliability, and criterion validity (accelerometer) in various contexts and languages.
Pre; 5 weeks
Brunnsviken Brief Quality of Life Inventory
Time Frame: Pre; 5 weeks
The Brunnsviken Brief Quality of Life Inventory (BBQ) measures quality of life within six domains: self-respect; values; leisure time; learning; creativity; and friends. The instrument uses a five-point scale, with a scale range of 0-96. Each domain is assessed according to its importance and contentment. BBQ has satisfactory internal consistency reliability (α=.68) and test-retest reliability (r=.89).
Pre; 5 weeks
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry
Time Frame: Pre; 6 months
TiC-P has been used in several studies for economic evaluations of healthcare consumption and productivity loss in mental health. Sickness absence were conceptualized as the self-rated number of days during the past three months absent from work while being physically or mentally ill.
Pre; 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Experiences Questionnaire
Time Frame: 6-month, 12-month
Primary outcome
6-month, 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2018

Primary Completion (ACTUAL)

February 15, 2019

Study Completion (ACTUAL)

May 26, 2020

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (ACTUAL)

February 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once published data will be made available on request via repository.

IPD Sharing Time Frame

When published.

IPD Sharing Access Criteria

On request or public.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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