Systematic Use of Telepsychiatry for Outpatients
Primary Purpose
Borderline Personality Disorder, Depressive Disorder, Ptsd
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Case management
Sponsored by
About this trial
This is an interventional supportive care trial for Borderline Personality Disorder
Eligibility Criteria
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.
Sites / Locations
- Psychiatric research unit, Region Zealand,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video group
In-person
Arm Description
Case management through video format
Case management through in person format
Outcomes
Primary Outcome Measures
The demand for video consultation (VC) in clinical practice.
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.
Patients' therapeutic alliance, assessed by working alliance inventory- client version (WAI-C)
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
Patients' satisfaction, assessed by client satisfaction questionnaire 8 (CSQ-8)
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
Patients' Symptom level, assessed by Symptom Checklist -10 (SCL-10)
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
Patients' well-being, assessed by World Health Organisation- Five Well-Being Index (WHO-5)
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
Patients' function, assessed by Sheehan Disability Scale (SDS)
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
Patient recovery, assessed by INSPIRE
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
The implementation and integration of VC in clinical practice, as assessed by a checklist developed for the case managers (CM).
The following properties are used to evaluate the implementation and integration properties:
type of technology patients use for VC sessions (Smartphone/tablet or personal computer/laptop)
patients' physical location during VC session (Home or outdoor)
the VC sessions confidentiality (Alone or with other persons)
duration of VC session
the content of the VC sessions (supportive, therapy, medication management, crisis/acute or "mix" content)
Descriptive statistics will be applied to evaluate the implementation and integration properties.
Patients' experiences regarding the use of VC
Semistructured interviews have been conducted to evaluate participants' experience regarding the use of VC technology in clinical practice.
Secondary Outcome Measures
Full Information
NCT ID
NCT05516238
First Posted
May 10, 2022
Last Updated
March 28, 2023
Sponsor
Psychiatric Research Unit, Region Zealand, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05516238
Brief Title
Systematic Use of Telepsychiatry for Outpatients
Official Title
Systematic Use of Telepsychiatry for Outpatients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
April 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psychiatric Research Unit, Region Zealand, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Depressive Disorder, Ptsd, Anxiety Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video group
Arm Type
Experimental
Arm Description
Case management through video format
Arm Title
In-person
Arm Type
Active Comparator
Arm Description
Case management through in person format
Intervention Type
Other
Intervention Name(s)
Case management
Intervention Description
Case management cover therapy (psychotherapy/psychoeducation), medication adjustment, training in daily living skills (supportive), and direct consultations in crises.
Primary Outcome Measure Information:
Title
The demand for video consultation (VC) in clinical practice.
Description
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.
Time Frame
One year
Title
Patients' therapeutic alliance, assessed by working alliance inventory- client version (WAI-C)
Description
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
Time Frame
Two months.
Title
Patients' satisfaction, assessed by client satisfaction questionnaire 8 (CSQ-8)
Description
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
Time Frame
Two months.
Title
Patients' Symptom level, assessed by Symptom Checklist -10 (SCL-10)
Description
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
Time Frame
Two months.
Title
Patients' well-being, assessed by World Health Organisation- Five Well-Being Index (WHO-5)
Description
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
Time Frame
Two months.
Title
Patients' function, assessed by Sheehan Disability Scale (SDS)
Description
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
Time Frame
Two months.
Title
Patient recovery, assessed by INSPIRE
Description
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
Time Frame
Two months.
Title
The implementation and integration of VC in clinical practice, as assessed by a checklist developed for the case managers (CM).
Description
The following properties are used to evaluate the implementation and integration properties:
type of technology patients use for VC sessions (Smartphone/tablet or personal computer/laptop)
patients' physical location during VC session (Home or outdoor)
the VC sessions confidentiality (Alone or with other persons)
duration of VC session
the content of the VC sessions (supportive, therapy, medication management, crisis/acute or "mix" content)
Descriptive statistics will be applied to evaluate the implementation and integration properties.
Time Frame
One year
Title
Patients' experiences regarding the use of VC
Description
Semistructured interviews have been conducted to evaluate participants' experience regarding the use of VC technology in clinical practice.
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Psychiatric research unit, Region Zealand,
City
Slagelse
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Systematic Use of Telepsychiatry for Outpatients
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