NCT05516238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

May 10, 2022

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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: 1. type of technology patients use for VC sessions (Smartphone/tablet or personal computer/laptop) 2. patients' physical location during VC session (Home or outdoor) 3. the VC sessions confidentiality (Alone or with other persons) 4. duration of VC session 5. 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

  • 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

Study Arms (2)

Video group

EXPERIMENTAL

Case management through video format

Other: Case management

In-person

ACTIVE COMPARATOR

Case management through in person format

Other: Case management

Interventions

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

In-personVideo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • Danish-speaking.

You may not qualify if:

  • Additionally, Participants in the VC group were excluded if they did not have a smartphone, tablet, laptop, or personal computer with a webcam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric research unit, Region Zealand,

Slagelse, Denmark

Location

MeSH Terms

Conditions

Borderline Personality DisorderDepressive DisorderStress Disorders, Post-TraumaticAnxiety Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersMood DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2022

First Posted

August 25, 2022

Study Start

April 21, 2021

Primary Completion

April 26, 2022

Study Completion

April 26, 2022

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations