- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516238
Systematic Use of Telepsychiatry for Outpatients
March 28, 2023 updated by: Psychiatric Research Unit, Region Zealand, Denmark
Implementation and evaluation of video consultation in psychiatric outpatient treatment.
The study will focus on patients' experiences regarding the use of VC.
The study will also examine important aspects of the telepsychiatric consultation such as therapeutic alliance, consultation content, psychopathology and satisfaction levels compared to face-to-face consultations.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Slagelse, Denmark
- Psychiatric research unit, Region Zealand,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age > 18 years
- Danish-speaking.
Exclusion Criteria:
- Exclusion criteria included a diagnosis of schizophrenia or bipolar disorder, or suffering from substance abuse.
- Additionally, Participants in the VC group were excluded if they did not have a smartphone, tablet, laptop, or personal computer with a webcam.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video group
Case management through video format
|
Case management cover therapy (psychotherapy/psychoeducation), medication adjustment, training in daily living skills (supportive), and direct consultations in crises.
|
|
Active Comparator: In-person
Case management through in person format
|
Case management cover therapy (psychotherapy/psychoeducation), medication adjustment, training in daily living skills (supportive), and direct consultations in crises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The demand for video consultation (VC) in clinical practice.
Time Frame: One year
|
The demand for VC is evaluated by the percentage of included participants who chose to be in the VC group and the actual use of VC consultation sessions during the study period, including the number of missed appointments and the number of times VC sessions have been converted to telephone or in-person (IP) consultations.
|
One year
|
|
The implementation and integration of VC in clinical practice, as assessed by a checklist developed for the case managers (CM).
Time Frame: One year
|
The following properties are used to evaluate the implementation and integration properties:
Descriptive statistics will be applied to evaluate the implementation and integration properties. |
One year
|
|
Patients' experiences regarding the use of VC
Time Frame: Two months
|
Semistructured interviews have been conducted to evaluate participants' experience regarding the use of VC technology in clinical practice.
|
Two months
|
|
Patients' therapeutic alliance, assessed by working alliance inventory- client version (WAI-C)
Time Frame: Two months.
|
Therapeutic alliance is evaluated with the mean change scores in the WAI-C questionnaire at baseline and posttreatment.
Score ranging: from 12 to 84.
Higher scores indicate a higher therapeutic alliance
|
Two months.
|
|
Patients' satisfaction, assessed by client satisfaction questionnaire 8 (CSQ-8)
Time Frame: Two months.
|
Satisfaction is evaluated with the mean change scores in the CSQ-8 questionnaire at baseline and posttreatment.
Score ranging: from 8 to 32.
Higher scores indicate a higher satisfaction
|
Two months.
|
|
Patients' Symptom level, assessed by Symptom Checklist -10 (SCL-10)
Time Frame: Two months.
|
Symptom level is evaluated with the mean change scores in the SCL-10 questionnaire at baseline and posttreatment.
Score ranging: from 0 to 100.
Lower score indicates lower psychological distress
|
Two months.
|
|
Patients' well-being, assessed by World Health Organisation- Five Well-Being Index (WHO-5)
Time Frame: Two months.
|
Well-being level is evaluated with the mean change scores in the WHO-5 questionnaire at baseline and posttreatment.
Score ranging: from 0 to 100.
Higher scores indicate higher well-being
|
Two months.
|
|
Patients' function, assessed by Sheehan Disability Scale (SDS)
Time Frame: Two months.
|
Functional impairment is evaluated with the mean change scores in the SDS questionnaire at baseline and posttreatment.
Score ranging: from 0 to 30.
lower scores indicate lower functional impairment
|
Two months.
|
|
Patient recovery, assessed by INSPIRE
Time Frame: Two months.
|
Patient recovery is evaluated with the mean change scores in the INSPIRE questionnaire at baseline and posttreatment.
Score ranging: from 0 to 100.
A higher score indicates higher recovery
|
Two months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2021
Primary Completion (Actual)
April 26, 2022
Study Completion (Actual)
April 26, 2022
Study Registration Dates
First Submitted
May 10, 2022
First Submitted That Met QC Criteria
August 23, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REG-003-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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