- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05220592
Learning How to Recover From Stress - Pilot RCT
Learning How to Recover From Stress: Results From an Internet-based Randomized Controlled Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Östergötland
-
Linköping, Östergötland, Sweden, 58183
- Department of Behavioral Sciences and Learning, Linköping University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- iStress4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Adjustment Disorders
-
University of ArizonaCompletedStress | Stress, Psychological | Stress Reaction | Adjustment | Adjustment, Emotional | Adjustment, Social
-
Université du Québec a MontréalCiusss de L'Est de l'Île de Montréal; PhysioExtra; EnergirCompletedAdjustment Disorders | Depression Anxiety Disorder | Adjustment Disorder With Anxious Mood | Adjustment Disorder With Depressed MoodCanada
-
Tel-Aviv Sourasky Medical CenterUnknownAdjustment Disorder
-
VistaGen Therapeutics, Inc.CompletedAdjustment Disorder With Anxious MoodUnited States
-
CHU de Quebec-Universite LavalLaval University; Canadian Cancer Society (CCS); Centre de recherche en cancérologie... and other collaboratorsUnknownCreating Meaning Following Cancer: An Intervention to Improve Existential and Global Quality of LifeAdjustment Disorder | Non-metastatic CancerCanada
-
Odense University HospitalRigshospitalet, Denmark; University of Southern DenmarkEnrolling by invitationAdjustment Disorder With Work InhibitionDenmark
-
The Chicago LighthouseRecruitingDepression, Anxiety | Visual Impairment | Adjustment Disorder With Anxious Mood | Blindness, Acquired | Vision Loss | Blindness and Low Vision | Adjustment | Adjustment Disorder With Depressed MoodUnited States
-
University of BernSwiss Accident Insurance Fund SUVACompletedMental Disorder | Adjustment Disorders | Adjustment Impairment | AccidentSwitzerland
-
University of California, IrvineMassachusetts Institute of Technology (MIT)Recruiting
-
Cambridge Health AllianceThe Arnold P. Gold Foundation; The Arthur Vining Davis FoundationsCompletedDepression | Anxiety | Adjustment Disorder | Stress Related DisorderUnited States
Clinical Trials on Internet-based recovery training program
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
University of Colorado, DenverNational Institute of Mental Health (NIMH)CompletedHIV Infections | Sexually Transmitted DiseasesUnited States
-
VA Office of Research and DevelopmentRecruitingPeripheral Artery DiseaseUnited States
-
Bout Me HealingCompletedSubstance Use Disorder (SUD) | Anxiety Disorder GeneralizedUnited States
-
Children's Hospital Medical Center, CincinnatiU.S. Department of EducationCompletedTraumatic Brain InjuryUnited States
-
Uppsala UniversityCompletedDepression | Cancer | AnxietySweden
-
University of LeipzigUnknown
-
Children's Hospital Medical Center, CincinnatiChildren's Hospital Colorado; Nationwide Children's Hospital; MetroHealth Medical... and other collaboratorsCompletedTraumatic Brain InjuryUnited States
-
Umeå UniversityUppsala UniversityCompleted
-
University of BernUniversity of ZurichCompleted