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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05516238
Other study ID # REG-003-2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2021
Est. completion date April 26, 2022

Study information

Verified date March 2023
Source Psychiatric Research Unit, Region Zealand, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date April 26, 2022
Est. primary completion date April 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Case management
Case management cover therapy (psychotherapy/psychoeducation), medication adjustment, training in daily living skills (supportive), and direct consultations in crises.

Locations

Country Name City State
Denmark Psychiatric research unit, Region Zealand, Slagelse

Sponsors (1)

Lead Sponsor Collaborator
Psychiatric Research Unit, Region Zealand, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. One year
Primary 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 Two months.
Primary 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 Two months.
Primary 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 Two months.
Primary 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 Two months.
Primary 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 Two months.
Primary 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 Two months.
Primary 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.
One year
Primary 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. Two months
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