Excessive WorryWorry-expNCT06609395

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

A study testing Brief online CBT targeting excessiv worry in people with Excessive Worry, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Excessive Worry
What is being tested?: Brief online CBT targeting excessiv worry
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteSweden
Study dates: 1 Jun 2022to 15 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

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

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Conditions: Excessive Worry
Being tested: Brief online CBT targeting excessiv worry
Keywords: Digital CBT, Brief intervention, Indian Expatriate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief online CBT targeting excessiv worryBehavioural
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.

Study groups in NCT06609395
Study group	Role	What they receive
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. Receives: Behavioral: Brief online CBT targeting excessiv worry

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline to 1-month follow-up ( 9 weeks)

Secondary outcomes (10)

Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
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.
Measured: Baseline to post-treatment (5 weeks)
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
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.
Measured: Baseline to 1-month follow-up ( 9 weeks)
Work and Social Adjustment Scale (WSAS)
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.
Measured: Baseline to post-treatment (5 weeks)
Work and Social Adjustment Scale (WSAS)
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.
Measured: Baseline to 1-month follow-up ( 9 weeks)
Insomnia Severity Index
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.
Measured: Baseline to post-treatment (5 weeks)
Insomnia Severity Index
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.
Measured: Baseline to 1-month follow-up ( 9 weeks)
Client Satisfaction Questionnaire CSQ
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.
Measured: Baseline to post-treatment (5 weeks)
Adverse events
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.
Measured: Baseline to post-treatment (5 weeks)
Adverse events
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.
Measured: Baseline to 1-month follow-up ( 9 weeks)
Adherence to treatment
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.
Measured: From baseline to treatment (5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202215 Oct 2022

First posted24 Sep 2024
Study start1 Jun 2022
Primary completion15 Oct 2022
Study completion15 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Excessive WorryStudies of the same condition, open and under way.
More trials run by Karolinska InstitutetThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open pilot study
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06609395
Sponsor's protocol ID: Worry-exp
Other IDs: 000
Acronym: Worry-exp
Status last verified: Sep 2024
First submitted: 22 Sep 2024
Last updated: 24 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: GDPR is not allowing.

Publications

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.
PubMed 33480484
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
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.
PubMed 35442432
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.
PubMed 33212440

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study Testing an Online-delivered Psychological Intervention for Indian Expatriates in Sweden Who Experience Dysfunctional Worry
ClinicalTrials.gov ID: NCT06609395
Acronym / sponsor ID: Worry-exp / Worry-exp
Conditions: Excessive Worry
Keywords: Digital CBT, Brief intervention, Indian Expatriate
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Study start: 1 Jun 2022 (actual)
Primary completion: 15 Oct 2022 (actual)
Study completion: 15 Oct 2022 (actual)
First posted: 24 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open pilot study

Arm	Type	Receives
Brief online CBT targeting excessive worry	Experimental	Behavioral: Brief online CBT targeting excessiv worryThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brief online CBT targeting excessiv worryThe 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.	Behavioural	Brief online CBT targeting excessive worry

Primary outcome

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.
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.

10 secondary outcomes

Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
Time frame: 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)
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline to post-treatment (5 weeks)
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline to 1-month follow-up ( 9 weeks)
Insomnia Severity Index
Time frame: Baseline to post-treatment (5 weeks)
Insomnia Severity Index
Time frame: Baseline to 1-month follow-up ( 9 weeks)
Client Satisfaction Questionnaire CSQ
Time frame: Baseline to post-treatment (5 weeks)
Adverse events
Time frame: Baseline to post-treatment (5 weeks)
Adverse events
Time frame: Baseline to 1-month follow-up ( 9 weeks)
Adherence to treatment
Time frame: From baseline to treatment (5 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Background: PubMed 33480484Uvais 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.
BackgroundVijayakumar, 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: PubMed 35442432Zhou 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.
Background: PubMed 33212440Wahlund 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.
Individual participant dataSharing planned: No. GDPR is not allowing.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nitya Jayaram-Lindström, PhD principal investigator

Karolinska Institutet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brief online CBT targeting excessiv worry in people with Excessive Worry, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generalized Anxiety Disorder Scale-7 (GAD-7) (time frame: Baseline to post-treatment (5 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06609395, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.