Clinical trial NCT06609395: Brief Online Cognitive Behavioral Therapy for Indian Expatriates with Excessive Worry: a Pilot Feasibility Study
Official title: Pilot Study Testing an Online-delivered Psychological Intervention for Indian Expatriates in Sweden Who Experience Dysfunctional Worry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Worry
Keywords: Digital CBT, Brief intervention, Indian Expatriate
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: Baseline to post-treatment (5 weeks)
measure: Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: Baseline to 1-month follow-up ( 9 weeks)
Secondary outcomes:
measure: Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
timeFrame: Baseline to post-treatment (5 weeks)
measure: Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
timeFrame: Baseline to 1-month follow-up ( 9 weeks)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline to post-treatment (5 weeks)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline to 1-month follow-up ( 9 weeks)
measure: Insomnia Severity Index
timeFrame: Baseline to post-treatment (5 weeks)
measure: Insomnia Severity Index
timeFrame: Baseline to 1-month follow-up ( 9 weeks)
measure: Client Satisfaction Questionnaire CSQ
timeFrame: Baseline to post-treatment (5 weeks)
measure: Adverse events
timeFrame: Baseline to post-treatment (5 weeks)
measure: Adverse events
timeFrame: Baseline to 1-month follow-up ( 9 weeks)
measure: Adherence to treatment
timeFrame: From baseline to treatment (5 weeks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Centre for Psychiatry Research, Karolinska Institutet, Stockholm Healthcare Services
Study officials:
affiliation: Karolinska Institutet
name: Nitya Jayaram-Lindström, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.