Reducing Worry in Patients with Medically Unexplained Symptoms: A Feasibility Study

Reducing Worry in Patients with Medically Unexplained Symptoms: A Feasibility Study - WorRI in MUS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42750

Enrollment

Registered

2016-04-12

Start date

2016-09-19

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

onverklaarde lichamelijke klachten medically unexplained symptoms

Interventions

Participants will be asked to immediately terminate their worries during the day, if they realize they are worrying. They are further asked to postpone these worries to a self-chosen 30-minute time

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients consulting their general practitioner for at least one medically unexplained symptom; - Patients in the age group of 18-80 years; - Patients with an iOS or Android smartphone to their use for the study period

Exclusion criteria

Exclusion criteria: - Patients younger than 18 or older than 80 years; - Patients suffering from chronic diseases or serious physical illness; - Patients with medically explained symptoms; - Patients with mental retardation; - Patients with severe psychiatric disorders (e.g. major depression); - Patients with insufficient ability to speak and/or write Dutch

Design outcomes

Primary

Measure	Time frame
Our primary outcome measure is the feasibility and acceptability of the WRI, measured primarily with in-depth interviews for which four GPs and approximately ten MUS-patients will be invited to talk about their experiences with the intervention. Additionally, patient satisfaction with the intervention, measured with a Likert-scale, ranging from 0 (not satisfied at all) to 5 (very satisfied), percentage of patient withdrawal and feasibility and ease with which general practitioners were able to include patients in the study, measured with a Visual Analogue Scale ranging from 0 (not easy at all) to 10 (very easy), will be assessed.	—

Measure

Time frame

Our primary outcome measure is the feasibility and acceptability of the WRI, measured primarily with in-depth interviews for which four GPs and approximately ten MUS-patients will be invited to talk about their experiences with the intervention. Additionally, patient satisfaction with the intervention, measured with a Likert-scale, ranging from 0 (not satisfied at all) to 5 (very satisfied), percentage of patient withdrawal and feasibility and ease with which general practitioners were able to include patients in the study, measured with a Visual Analogue Scale ranging from 0 (not easy at all) to 10 (very easy), will be assessed.

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Secondary

Measure	Time frame
Secundary outcome measures are: somatization, distress, depression and anxiety as measured by the Vier-Dimensionele Klachtenlijst, perceived symptom severity as measured with a Visual Analogue Scale ranging from 0 (no symptoms) to 10 (very severe symptoms), spirituality as measured with two scales (trust and acceptance) of the Spiritual Attitude and Involvement List, worry frequency, worry duration, affect and success of postponement will be measured with the experience sampling method, using an application on a smartpone which will send 8 prompts per day to the participants, and lastly, repetitive negative thinking will be measured with the Perseverative Thinking Questionnaire.	—

Measure

Time frame

Secundary outcome measures are: somatization, distress, depression and anxiety as measured by the Vier-Dimensionele Klachtenlijst, perceived symptom severity as measured with a Visual Analogue Scale ranging from 0 (no symptoms) to 10 (very severe symptoms), spirituality as measured with two scales (trust and acceptance) of the Spiritual Attitude and Involvement List, worry frequency, worry duration, affect and success of postponement will be measured with the experience sampling method, using an application on a smartpone which will send 8 prompts per day to the participants, and lastly, repetitive negative thinking will be measured with the Perseverative Thinking Questionnaire.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)