Brief Online Cognitive Behavioral Therapy for Indian Expatriates with Excessive Worry: a Pilot Feasibility Study (Worry-exp)

September 22, 2024 updated by: Nitya Jayaram-Lindstrom, Karolinska Institutet

Pilot Study Testing an Online-delivered Psychological Intervention for Indian Expatriates in Sweden Who Experience Dysfunctional Worry

Background: Expatriates may face challenges through distance from support systems, cultural adjustments, and language barriers, which may be associated with anxiety and elevated worry, particularly in times of ongoing global crises. Brief online cognitive-behavioral therapy (ICBT) is effective for treating excessive worry but has not been adapted for expatriate communities in Sweden.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study aimed to investigate the feasibility, acceptability, and preliminary treatment effects of a five-week, therapist-guided, culturally adapted ICBT program. The program targeted excessive worry related to ongoing global crises among Indian expatriates.

Study Type

Interventional

Enrollment (Actual)

24

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

  • Sweden
      • Stockholm, Sweden, 17177
        • Centre for Psychiatry Research, Karolinska Institutet, Stockholm Healthcare Services

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • identifying as Indian expatriate currently living in Sweden
  • self-reported dysfunctional worry, defined as worrying several times a day and the worry being experienced as difficult to control
  • age ≥ 18 years;
  • able to provide digital informed consent
  • having daily access to a device with internet connection.

Exclusion Criteria:

  • non-English speaking
  • self-reported severe depression (>28 points on the Montgomery Åsberg Depression Rating Scale (MADRS-S; (Svanborg & Åsberg, 1994)
  • suicidal risk (5 points on item 9 on the MADRS-S).

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief online CBT targeting excessive worry
The treatment in this trial was based on an online CBT intervention developed by Wahlund et al. (2021) for dysfunctional worry during the COVID-19 pandemic. Originally designed for the Swedish population, the intervention was translated to English and adapted for Indian expatriates in Sweden, addressing broader global crises, including military conflicts and climate change.
Behavioral: Brief online CBT targeting excessiv worry
The intervention with a focus on excessive worry lasted five weeks and was delivered through five online modules with therapist support. Modules covered psychoeducation, problem-solving, reducing excessive media consumption, detached mindfulness, and shifting focus from worry. The final module offered relapse prevention strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder Scale-7 (GAD-7)
Time Frame: Baseline to post-treatment (5 weeks)
The GAD-7 is a 7-item self-report tool used to assess generalized anxiety disorder severity. It scores symptoms like worry and restlessness over the past two weeks on a scale of 0 to 3, with a total score of 0-21. Scores categorize anxiety as mild, moderate, or severe.
Baseline to post-treatment (5 weeks)
Generalized Anxiety Disorder Scale-7 (GAD-7)
Time Frame: Baseline to 1-month follow-up ( 9 weeks)
The GAD-7 is a 7-item self-report tool used to assess generalized anxiety disorder severity. It scores symptoms like worry and restlessness over the past two weeks on a scale of 0 to 3, with a total score of 0-21. Scores categorize anxiety as mild, moderate, or severe.
Baseline to 1-month follow-up ( 9 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
Time Frame: Baseline to post-treatment (5 weeks)
The MADRS-S is a 9-item self-report scale for assessing depression severity. Each item is scored 0 to 6, with higher scores reflecting more severe symptoms like mood, sleep, and concentration issues.
Baseline to post-treatment (5 weeks)
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
Time Frame: Baseline to 1-month follow-up ( 9 weeks)
The MADRS-S is a 9-item self-report scale for assessing depression severity. Each item is scored 0 to 6, with higher scores reflecting more severe symptoms like mood, sleep, and concentration issues.
Baseline to 1-month follow-up ( 9 weeks)
Work and Social Adjustment Scale (WSAS)
Time Frame: Baseline to post-treatment (5 weeks)
The WSAS is a 5-item self-report scale measuring how mental health issues affect work, home tasks, social life, and relationships. Higher scores indicate greater impairment.
Baseline to post-treatment (5 weeks)
Work and Social Adjustment Scale (WSAS)
Time Frame: Baseline to 1-month follow-up ( 9 weeks)
The WSAS is a 5-item self-report scale measuring how mental health issues affect work, home tasks, social life, and relationships. Higher scores indicate greater impairment.
Baseline to 1-month follow-up ( 9 weeks)
Insomnia Severity Index
Time Frame: Baseline to post-treatment (5 weeks)
The Insomnia Severity Index (ISI) is a 7-item scale assessing insomnia severity, including sleep issues and daytime impact. Higher scores indicate more severe insomnia.
Baseline to post-treatment (5 weeks)
Insomnia Severity Index
Time Frame: Baseline to 1-month follow-up ( 9 weeks)
The Insomnia Severity Index (ISI) is a 7-item scale assessing insomnia severity, including sleep issues and daytime impact. Higher scores indicate more severe insomnia.
Baseline to 1-month follow-up ( 9 weeks)
Client Satisfaction Questionnaire CSQ
Time Frame: Baseline to post-treatment (5 weeks)

The Patient Satisfaction Questionnaire (PSQ) is a self-report tool that measures patients' satisfaction with healthcare services. It covers aspects like quality of care, communication, convenience, and overall experience. Higher scores indicate greater satisfaction.

The Patient Satisfaction Questionnaire (PSQ) is a self-report tool that measures patients' satisfaction with intervention. It covers aspects like quality of care, communication, convenience, and overall experience. Higher scores indicate greater satisfaction.

he Patient Satisfaction Questionnaire (PSQ) measures patients' satisfaction with healthcare, focusing on care quality, communication, and convenience. Higher scores show greater satisfaction.
Baseline to post-treatment (5 weeks)
Adverse events
Time Frame: Baseline to post-treatment (5 weeks)
Adverse events for participating in the intervention may include increased anxiety, emotional distress, or frustration. Patients rate the severity and duration of these events on a scale from 0 to 3.
Baseline to post-treatment (5 weeks)
Adverse events
Time Frame: Baseline to 1-month follow-up ( 9 weeks)
Adverse events for participating in the intervention may include increased anxiety, emotional distress, or frustration. Patients rate the severity and duration of these events on a scale from 0 to 3.
Baseline to 1-month follow-up ( 9 weeks)
Adherence to treatment
Time Frame: From baseline to treatment (5 weeks)
Treatment completion was defined as a participant successfully finishing at least four out of the five treatment modules (described below) included returning the associated homework assignment linked to each module. This level was set as modules 1-4 provide the core components of the treatment.
From baseline to treatment (5 weeks)

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Nitya Jayaram-Lindström, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2022

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Worry-exp
  • 000 (Other Identifier: YCTG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

GDPR is not allowing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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