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Completed

NCT Number: NCT06609395

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

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.

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Key information

Conditions

Excessive Worry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Psychiatry Research, Karolinska Institutet, Stockholm Healthcare Services

Stockholm, 17177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Brief online CBT targeting excessiv worry

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: Worry-exp

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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