SchizophreniaVAGT-WHCMISNCT05954208
Vısual Arts Group Therapy Based On Watson's Human Care Model In Indıvıduals Wıth Schızophrenıa
A study testing Vısual Arts Group Therapy Based On Watson's Human Care Model and Ongoing treatment in people with Schizophrenia and Art Therapy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study was conducted to evaluate the effect of Visual Arts Group Therapy based on Watson's Human Care Model (VAGT-WHCM) on perceived social support and functional improvement in individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Art Therapy, Social Support
- What is being tested?
- Vısual Arts Group Therapy Based On Watson's Human Care Model and Ongoing treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2022to 1 Jun 2023
- 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
- Volunteering to participate in the study
- Meeting the diagnostic criteria for schizophrenia according to DSM-5 and being diagnosed with schizophrenia
- Being 18 years or older
- Being in remission (reported by the psychiatrist following the patient in the institution)
- Having medium and high level of insight (reported by the psychiatrist following the patient in the institution)
- Ability to read, understand and respond to instructions and data forms used
Who cannot join
- Having a diagnosis of a psychotic mental disorder in addition to the diagnosis of schizophrenia
- Using alcohol or psychoactive substances (reported by the doctor/nurse following the patient in the institution)
- Having a mental illness that makes cooperation impossible, such as mental retardation or dementia
- Having a serious physical illness such as cancer
- Being in an acute psychotic process
- Having visual, auditory, speech (verbal) and upper extremity defects
- Having participated in an art therapy program before
- Continuing any individual therapy or group therapy during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Visual Arts Group Therapy Based On Watson's Human Care Model On Perceived Social Support And Functional Recovery In Individuals With Schizophrenia
Purpose: This study was conducted to evaluate the effect of Visual Arts Group Therapy based on Watson's Human Care Model (VAGT-WHCM) on perceived social support and functional improvement in individuals with schizophrenia.
Design: This research was carried out as a randomized controlled experimental study with a pre-test-post-test and follow-up design, which is one of the quantitative research methods.
Read more
Method: The study was carried out in Yenimahalle Community Mental Health Center between December 2022 and January 2023. The sample of the study consisted of 67 individuals diagnosed with schizophrenia, including the intervention (n=34) and control group (n=33), who met the inclusion criteria and were determined by simple randomization method. VAGT-WHCM was applied to the intervention group, consisting of six sessions, lasting 90 minutes on average, once a week in three groups. The control group participated only in the routine follow-up, treatment and practices in the institution. The intervention and control groups were evaluated with the "Multidimensional Scale of Perceived Social Support (MSPSS)" and the "Functional Recovery Scale (FRS)" before therapy (pre-test), post-therapy (post-test), and one month later (follow-up). The CONSORT (Consolidated Standards of Reporting Trials) flowcart is used in this study.
Hypothesis:
H1-1: Visual arts group therapy has an effect on perceived social support by individuals with schizophrenia.
H1-2: Visual arts group therapy has an effect on the functional recovery levels of individuals with schizophrenia.
H1-3: The change in the perceived social support level of individuals with schizophrenia before and after visual arts group therapy is associated with the change in functional recovery.
- Conditions
- Schizophrenia, Art Therapy, Social Support
- Being tested
- Vısual Arts Group Therapy Based On Watson's Human Care Model, Ongoing treatment
- Keywords
- Schizophrenia, Visual arts therapy, Nursing model, Perceived social support, Functional recovery, Randomized controlled study
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vısual Arts Group Therapy Based On Watson's Human Care ModelOther
VAGT-WHCM was applied to the intervention group, consisting of six sessions, lasting 90 minutes on average, once a week in three groups.
Ongoing treatmentOther
The control group participated only in the routine follow-up, treatment and practices in the institution.
| Study group | Role | What they receive |
|---|---|---|
| VAGT-WHCM | Experimental | Vısual Arts Group Therapy Based On Watson's Human Care Model Receives: Other: Vısual Arts Group Therapy Based On Watson's Human Care Model |
| Control group | Active comparator | Routine follow-up, treatment in the institution Receives: Other: Ongoing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Social Support
The scale, which consists of a total of 12 questions, is evaluated in a 7-point Likert type. The participant chooses one of the options from 'Absolutely No' to 'Definitely Yes' in order to express the perceived support. It consists of three subscales, which are family, friend and personal support, which reflect the sources of support within the scale. The lowest total score that can be obtained from the scale is 12, and the highest score is 84. It is not the cut-off point of the scale, and the high score obtained from the scale indicates that the perceived social support is high.
Measured: Change from patients' perceived social support levels at two months
Functional Recovery
The scale is a 5-point Likert-type scale consisting of 19 items. There are 5 evaluation levels for each item in the scale. Level 1 (absent) indicates the lowest level of improvement, while level 5 (excellent level) corresponds to the ideal level of functioning. It consists of Level 2 (partially present), Level 3 (have enough), Level 4 (almost fully present). High scores from the scale indicate high functionality, and low scores from the scale indicate low functionality. When you fall between the two levels, the lower level is selected. The maximum score that can be obtained from the scale is 95, and the minimum score is 19.The scale consists of 4 sub-dimensions. These are social functioning, health and treatment, daily living skills and occupational functioning.
Measured: Change from patients' functional recovery levels at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start14 Dec 2022
- Primary completion19 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Düzgün, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954208
- Sponsor's protocol ID
- 78643
- Acronym
- VAGT-WHCMIS
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 20 Jul 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Visual Arts Group Therapy Based On Watson's Human Care Model On Perceived Social Support And Functional Recovery In Individuals With Schizophrenia
- ClinicalTrials.gov ID
- NCT05954208
- Acronym / sponsor ID
- VAGT-WHCMIS / 78643
- Conditions
- Schizophrenia, Art Therapy, Social Support
- Keywords
- Schizophrenia, Visual arts therapy, Nursing model, Perceived social support, Functional recovery, Randomized controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 20 Jul 2023 (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.
Purpose: This study was conducted to evaluate the effect of Visual Arts Group Therapy based on Watson's Human Care Model (VAGT-WHCM) on perceived social support and functional improvement in individuals with schizophrenia.
Design: This research was carried out as a randomized controlled experimental study with a pre-test-post-test and follow-up design, which is one of the quantitative research methods.
Method: The study was carried out in Yenimahalle Community Mental Health Center between December 2022 and January 2023. The sample of the study consisted of 67 individuals diagnosed with schizophrenia, including the intervention (n=34) and control group (n=33), who met the inclusion criteria and were determined by simple randomization method. VAGT-WHCM was applied to the intervention group, consisting of six sessions, lasting 90 minutes on average, once a week in three groups. The control group participated only in the routine follow-up, treatment and practices in the institution. The intervention and control groups were evaluated with the "Multidimensional Scale of Perceived Social Support (MSPSS)" and the "Functional Recovery Scale (FRS)" before therapy (pre-test), post-therapy (post-test), and one month later (follow-up). The CONSORT (Consolidated Standards of Reporting Trials) flowcart is used in this study.
Hypothesis:
H1-1: Visual arts group therapy has an effect on perceived social support by individuals with schizophrenia.
H1-2: Visual arts group therapy has an effect on the functional recovery levels of individuals with schizophrenia.
H1-3: The change in the perceived social support level of individuals with schizophrenia before and after visual arts group therapy is associated with the change in functional recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAGT-WHCM | Experimental | Other: Vısual Arts Group Therapy Based On Watson's Human Care ModelVısual Arts Group Therapy Based On Watson's Human Care Model |
| Control group | Active comparator | Other: Ongoing treatmentRoutine follow-up, treatment in the institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the study
- Meeting the diagnostic criteria for schizophrenia according to DSM-5 and being diagnosed with schizophrenia
- Being 18 years or older
- Being in remission (reported by the psychiatrist following the patient in the institution)
- Having medium and high level of insight (reported by the psychiatrist following the patient in the institution)
Key exclusion criteria (8 listed)
- Having a diagnosis of a psychotic mental disorder in addition to the diagnosis of schizophrenia
- Using alcohol or psychoactive substances (reported by the doctor/nurse following the patient in the institution)
- Having a mental illness that makes cooperation impossible, such as mental retardation or dementia
- Having a serious physical illness such as cancer
- Being in an acute psychotic process
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 |
|---|---|---|
| Vısual Arts Group Therapy Based On Watson's Human Care ModelVAGT-WHCM was applied to the intervention group, consisting of six sessions, lasting 90 minutes on average, once a week in three groups. | Other | VAGT-WHCM |
| Ongoing treatmentThe control group participated only in the routine follow-up, treatment and practices in the institution. | Other | Control group |
Primary outcome
Perceived Social Support
Time frame: Change from patients' perceived social support levels at two months
The scale, which consists of a total of 12 questions, is evaluated in a 7-point Likert type. The participant chooses one of the options from 'Absolutely No' to 'Definitely Yes' in order to express the perceived support. It consists of three subscales, which are family, friend and personal support, which reflect the sources of support within the scale. The lowest total score that can be obtained from the scale is 12, and the highest score is 84. It is not the cut-off point of the scale, and the high score obtained from the scale indicates that the perceived social support is high.
Functional Recovery
Time frame: Change from patients' functional recovery levels at two months
The scale is a 5-point Likert-type scale consisting of 19 items. There are 5 evaluation levels for each item in the scale. Level 1 (absent) indicates the lowest level of improvement, while level 5 (excellent level) corresponds to the ideal level of functioning. It consists of Level 2 (partially present), Level 3 (have enough), Level 4 (almost fully present). High scores from the scale indicate high functionality, and low scores from the scale indicate low functionality. When you fall between the two levels, the lower level is selected. The maximum score that can be obtained from the scale is 95, and the minimum score is 19.The scale consists of 4 sub-dimensions. These are social functioning, health and treatment, daily living skills and occupational functioning.
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 20 Jul 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 Vısual Arts Group Therapy Based On Watson's Human Care Model and Ongoing treatment in people with Schizophrenia and Art Therapy, run by Gazi University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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 20 Jul 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 Turkey (Türkiye). 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?
Perceived Social Support (time frame: Change from patients' perceived social support levels at two months). The study lists 2 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 20 Jul 2023.