Adjustment DisordersNCT05220592
Learning How to Recover From Stress - Pilot RCT
A study testing Internet-based recovery training program in people with Adjustment Disorders, run by Linkoeping University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adjustment Disorders
- What is being tested?
- Internet-based recovery training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2018to 26 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- <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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: 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.
Read the 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.
- Conditions
- Adjustment Disorders
- Being tested
- Internet-based recovery training program
- Keywords
- Recovery, Stress, Internet-based, Prevention, Intervention, Work
- Medical subject headings
- Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based recovery training programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based recovery training program (n=35) | Experimental | 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. Receives: Behavioral: Internet-based recovery training program |
| Wait-list control group (n=34) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recovery Experiences Questionnaire
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].
Measured: Pre; 5 weeks
Secondary outcomes (12)
Shirom-Melamed Burnout Questionnaire
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..
Measured: Pre; 5 weeks
Perceived Stress Scale
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.
Measured: Pre; 5 weeks
Karolinska Exhaustion Disorder Scale
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.
Measured: Pre; 5 weeks
Montgomery Åsberg Depression Rating Scale
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.
Measured: Pre; 5 weeks
Generalised Anxiety Disorder Scale
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.
Measured: Pre; 5 weeks
Insomnia Severity Index
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.
Measured: Pre; 5 weeks
Alcohol Use Disorders Identification Test
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.
Measured: Pre; 5 weeks
Work Experience Measurement Scale
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.
Measured: Pre; 5 weeks
Work Ability Index
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.
Measured: Pre; 5 weeks
International Physical Activity Questionnaire
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.
Measured: Pre; 5 weeks
Brunnsviken Brief Quality of Life Inventory
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).
Measured: Pre; 5 weeks
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry
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.
Measured: Pre; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start15 Feb 2018
- Primary completion15 Feb 2019
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjustment DisordersStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220592
- Sponsor's protocol ID
- iStress4
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once published data will be made available on request via repository.
Publications
Asplund RP, Carvallo F, Christensson H, Videsater E, Haggman A, Ljotsson B, Carlbring P, Andersson G. Learning how to recover from stress: Results from an internet-based randomized controlled pilot trial. Internet Interv. 2023 Oct 17;34:100681. doi: 10.1016/j.invent.2023.100681. eCollection 2023 Dec.
PubMed 38023967
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning How to Recover From Stress: Results From an Internet-based Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05220592
- Acronym / sponsor ID
- iStress4
- Conditions
- Adjustment Disorders
- Keywords
- Recovery, Stress, Internet-based, Prevention, Intervention, Work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Internet-based recovery training program (n=35) | Experimental | Behavioral: Internet-based recovery training programThe 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. |
| Wait-list control group (n=34) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based recovery training programThe 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. | Behavioural | Internet-based recovery training program (n=35) |
Primary outcome
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].
12 secondary outcomes
Shirom-Melamed Burnout Questionnaire
Time frame: Pre; 5 weeks
Perceived Stress Scale
Time frame: Pre; 5 weeks
Karolinska Exhaustion Disorder Scale
Time frame: Pre; 5 weeks
Montgomery Åsberg Depression Rating Scale
Time frame: Pre; 5 weeks
Generalised Anxiety Disorder Scale
Time frame: Pre; 5 weeks
Insomnia Severity Index
Time frame: Pre; 5 weeks
Alcohol Use Disorders Identification Test
Time frame: Pre; 5 weeks
Work Experience Measurement Scale
Time frame: Pre; 5 weeks
Work Ability Index
Time frame: Pre; 5 weeks
International Physical Activity Questionnaire
Time frame: Pre; 5 weeks
Brunnsviken Brief Quality of Life Inventory
Time frame: Pre; 5 weeks
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry
Time frame: Pre; 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Derived from this study: PubMed 38023967Asplund RP, Carvallo F, Christensson H, Videsater E, Haggman A, Ljotsson B, Carlbring P, Andersson G. Learning how to recover from stress: Results from an internet-based randomized controlled pilot trial. Internet Interv. 2023 Oct 17;34:100681. doi: 10.1016/j.invent.2023.100681. eCollection 2023 Dec.
- Individual participant dataSharing planned: Yes. Once published data will be made available on request via repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based recovery training program in people with Adjustment Disorders, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery Experiences Questionnaire (time frame: Pre; 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.