Borderline Personality DisorderNCT05516238
Systematic Use of Telepsychiatry for Outpatients
A study testing Case management in people with Borderline Personality Disorder and Depressive Disorder, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, Depressive Disorder, Ptsd
- What is being tested?
- Case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Apr 2021to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years
- Danish-speaking.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Case management
- Medical subject headings
- Borderline Personality Disorder, Depressive Disorder, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementOther
Case management cover therapy (psychotherapy/psychoeducation), medication adjustment, training in daily living skills (supportive), and direct consultations in crises.
| Study group | Role | What they receive |
|---|---|---|
| Video group | Experimental | Case management through video format Receives: Other: Case management |
| In-person | Active comparator | Case management through in person format Receives: Other: Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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:
- 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.
Measured: 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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start21 Apr 2021
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516238
- Sponsor's protocol ID
- REG-003-2021
- Status last verified
- Mar 2023
- First submitted
- 10 May 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Use of Telepsychiatry for Outpatients
- ClinicalTrials.gov ID
- NCT05516238
- Acronym / sponsor ID
- REG-003-2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, DenmarkUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video group | Experimental | Other: Case managementCase management through video format |
| In-person | Active comparator | Other: Case managementCase management through in person format |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- Danish-speaking.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case managementCase management cover therapy (psychotherapy/psychoeducation), medication adjustment, training in daily living skills (supportive), and direct consultations in crises. | Other | In-person, Video group |
Primary outcome
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.
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
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
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
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
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
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
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: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management in people with Borderline Personality Disorder and Depressive Disorder, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The demand for video consultation (VC) in clinical practice. (time frame: One year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.