NCT05220592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

January 20, 2022

Last Update Submit

February 1, 2022

Conditions

Keywords

RecoveryStressInternet-basedPreventionInterventionWork

Outcome Measures

Primary Outcomes (1)

  • 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 \[83\].

    Pre; 5 weeks

Secondary Outcomes (12)

  • Shirom-Melamed Burnout Questionnaire

    Pre; 5 weeks

  • Perceived Stress Scale

    Pre; 5 weeks

  • Karolinska Exhaustion Disorder Scale

    Pre; 5 weeks

  • Montgomery Åsberg Depression Rating Scale

    Pre; 5 weeks

  • Generalised Anxiety Disorder Scale

    Pre; 5 weeks

  • +7 more secondary outcomes

Other Outcomes (1)

  • Recovery Experiences Questionnaire

    6-month, 12-month

Study Arms (2)

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.

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.

Interventions

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.

Internet-based recovery training program (n=35)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Adjustment Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Gerhard Andersson, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 2, 2022

Study Start

February 15, 2018

Primary Completion

February 15, 2019

Study Completion

May 26, 2020

Last Updated

February 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

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

Time Frame
When published.
Access Criteria
On request or public.

Locations