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

Not Applicable

Completed

• Conditions: Excessive Worry
• Interventions: Behavioral: Brief online CBT targeting excessiv worry

• Registration Number: NCT06609395
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

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 Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-22
• Last Update Submitted: 2024-09-22
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brief online CBT targeting excessive worry	Brief online CBT targeting excessiv 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.

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder Scale-7 (GAD-7)	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.

Secondary Outcome Measures

Name	Time	Method
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)	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.
Work and Social Adjustment Scale (WSAS)	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.
Insomnia Severity Index	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.
Client Satisfaction Questionnaire CSQ	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.
Adverse events	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.
Adherence to treatment	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.

Trial Locations

Locations (1)

Centre for Psychiatry Research, Karolinska Institutet, Stockholm Healthcare Services; 🇸🇪 Stockholm, Sweden