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

NCT06609395 | Completed

• 2 other identifiers: Worry-exp000
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Excessive Worry

Keywords

Digital CBT, Brief intervention, Indian Expatriate

Outcome Measures

Primary Outcomes (2)

• Generalized Anxiety Disorder Scale-7 (GAD-7)

  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)

  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 Outcomes (10)

• Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)

  Baseline to post-treatment (5 weeks)

• Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)

  Baseline to 1-month follow-up ( 9 weeks)

• Work and Social Adjustment Scale (WSAS)

  Baseline to post-treatment (5 weeks)

• Work and Social Adjustment Scale (WSAS)

  Baseline to 1-month follow-up ( 9 weeks)

• Insomnia Severity Index

  Baseline to post-treatment (5 weeks)

Study Arms (1)

Brief online CBT targeting excessive worry

EXPERIMENTAL

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

Interventions

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.

Brief online CBT targeting excessive worry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Centre for Psychiatry Research, Karolinska Institutet, Stockholm Healthcare Services

Stockholm, 17177, Sweden

Location

Related Publications (4)

• Uvais NA, Nalakath MJ, Shihabudheen P, Hafi NAB, Salman CA. Depression, Anxiety, and Coping During the COVID-19 Pandemic Among Indian Expats in the Middle East: A Survey Study. Prim Care Companion CNS Disord. 2021 Jan 21;23(1):20m02761. doi: 10.4088/PCC.20m02761.

  PMID: 33480484 BACKGROUND

• Vijayakumar, P. B., & Cunningham, C. J. L. (2016). Cross-cultural adjustment and expatriation motives among Indian expatriates. Journal of Global Mobility: The Home of Expatriate Management Research, 4(3), 326-344. https://doi.org/10.1108/jgm-05-2016-0019

  BACKGROUND

• Zhou ES, Ritterband LM, Bethea TN, Robles YP, Heeren TC, Rosenberg L. Effect of Culturally Tailored, Internet-Delivered Cognitive Behavioral Therapy for Insomnia in Black Women: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jun 1;79(6):538-549. doi: 10.1001/jamapsychiatry.2022.0653.

  PMID: 35442432 BACKGROUND

• Wahlund T, Mataix-Cols D, Olofsdotter Lauri K, de Schipper E, Ljotsson B, Aspvall K, Andersson E. Brief Online Cognitive Behavioural Intervention for Dysfunctional Worry Related to the COVID-19 Pandemic: A Randomised Controlled Trial. Psychother Psychosom. 2021;90(3):191-199. doi: 10.1159/000512843. Epub 2020 Nov 19.

  PMID: 33212440 BACKGROUND

Study Officials

• Nitya Jayaram-Lindström, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Director of Centre for Psychiatry Research

Model Details: Open pilot study

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 24, 2024
• Study Start: June 1, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)