NCT05954208

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable schizophrenia

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

December 14, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

July 4, 2023

Last Update Submit

July 12, 2023

Conditions

Keywords

SchizophreniaVisual arts therapyNursing modelPerceived social supportFunctional recoveryRandomized controlled study

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Change from patients' functional recovery levels at two months

Study Arms (2)

VAGT-WHCM

EXPERIMENTAL

Vısual Arts Group Therapy Based On Watson's Human Care Model

Other: Vısual Arts Group Therapy Based On Watson's Human Care Model

Control group

ACTIVE COMPARATOR

Routine follow-up, treatment in the institution

Other: Ongoing treatment

Interventions

VAGT-WHCM was applied to the intervention group, consisting of six sessions, lasting 90 minutes on average, once a week in three groups.

VAGT-WHCM

The control group participated only in the routine follow-up, treatment and practices in the institution.

Control group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 20, 2023

Study Start

December 14, 2022

Primary Completion

January 19, 2023

Study Completion

June 1, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations