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临床试验/NCT04107389
NCT04107389已完成不适用

Developing an Evidence Base for the Use of Art Psychotherapy Within a Perinatal Mental Health Service

University of Derby2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Monitor patient reported quality of life during the term of the Art Therapy intervention.

研究概览

简要总结

Primary Outcomes:

  • To measure the impact of art therapy within this specific perinatal client group
  • Attempt to establish a quality evidence base for the intervention within this setting

Secondary Outcomes:

  • Capture the participants lived experience of Art Therapy
  • Measure participant interaction with art materials during Art Therapy intervention
  • Measure any changes in mental wellbeing of the participants during Art Therapy intervention
  • Monitor patient reported quality of life during Art Therapy intervention
  • Record changes in mother-infant interaction during Art Therapy intervention

Hypotheses:

  • The measures will show an improvement in mental wellbeing, quality of life and mother-infant interaction in participants who receive the Art Therapy intervention compared to the baseline measurements taken at the start of the intervention.
  • The wait-list control group who have not yet received the intervention will display lower scores on the above measures, prior to receiving the Art Therapy intervention.

The aim of this study is to measure the impact of art therapy within this specific perinatal client group in order to attempt to establish an evidence base for the intervention within this setting; while following a primarily quantitative approach with complimentary qualitative elements. Art Therapy is a form of psychotherapy, based upon the premise of utilising art materials as a form of expression and communication; the roots of the theoretical approach lie in a psychodynamic approach to working with the unconscious.

详细描述

Methodology:

I intend to use a wait-list control group, whereby following admission to the unit a patient will follow the recruitment process detailed below, only after the recruitment process has been completed in full would consenting patients be randomised to an intervention group which will begin Art Therapy sessions in due course, or to a wait-list control group for a minimum of two weeks and a maximum of six weeks. The intervention group members will receive the Art Therapy intervention, while the waitlist control group are fully aware of the research and are waiting to receive it at a later date. The waitlist participants will be made fully aware that if they are discharged before therapy has become available to them, or if they reach the maximum term of 6 weeks on the waiting list, then they may not receive the intervention. Participants who reach the maximum term of 6 weeks on the waiting list while waiting for therapy availability will be withdrawn from the research and offered a debrief meeting in order to answer any remaining questions about the research. This maximum six week term is based upon the six week average duration of patient stay within the unit.

I am a qualified Art Psychotherapist and will be using a non-directive approach in order that the clients will lead their interactions with the art materials and with the therapy process.

Art Therapists are governed by the British Association of Art Therapists and the Health and Care Professions council who each set standards of professional therapy delivery. I will establish and facilitate a safe therapeutic provision of weekly individual Art Therapy sessions for patients of the unit.

I will work closely with the unit staff team in order to introduce and create a shared understanding about the therapeutic intentions of the art therapy provision. The additional benefit of employing a non-directive, client centred approach to Art Therapy sessions is that this will ensure that the clients themselves have key influence over the theme and artistic content of therapy sessions. The client presentation will then be analysed using a series of recognised quantitative scales to monitor client progress, therefore minimising the influence of the multiple therapists on the research data and increasing the quality of the data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Individuals admitted to the perinatal Mother and Baby unit who are able to speak English and who consent to take part.

排除标准

  • Individuals who do not speak English.
  • Individuals who do not consent to take part.

结局指标

主要结局

Monitor patient reported quality of life during the term of the Art Therapy intervention.

时间窗: Duration of therapeutic intervention within unit - approximately one year.

ReQol20 (Recovering Quality of Life) - Patient reported outcome measure. To assess the quality of life for people with varying mental health conditions. Used once during the one week assessment period and once at the end of the five week therapy engagement. A ReQoL20 score between 0 and 49 is considered as falling within the clinical range. A score of 50 and above is considered as falling within the range of the general population.

Monitor patient reported quality of life during the term of the Art Therapy intervention and during the wait-list period.

时间窗: Duration of therapeutic intervention within unit - approximately one year.

ReQol10 (Recovering Quality of Life) - Patient reported outcome measure. To assess the quality of life for people with varying mental health conditions. Used once during the one week assessment period and once at the end of the five week therapy engagement. The ReQol10 scale which includes 10 questions, used weekly for the duration of the engagement in therapy and during the wait-list period. A ReQoL-10 score between 0 and 24 is considered as falling within the clinical range. A score of 25 and above is considered as falling within the range of the general population

Monitor changes in mother-infant interaction during the term of the Art Therapy intervention and during the wait-list period.

时间窗: Duration of therapeutic intervention within unit - approximately one year.

Bethlem Mother-Infant Interaction Scale - Assesses disturbances of mother-infant interaction. This scale will be used weekly for the duration of the engagement in therapy (maximum five week duration available) and during the wait-list period (a minimum duration of two weeks and maximum of six weeks). 7-item, 5-point rating scale used to measure mother-infant adjustment. Scoring is rated from 0 to 4, with 0 indicating the mother is judged to be interacting with her baby in an appropriate, sensitive and well- organised manner. A rating of 4 indicates that the mother and infant have been nursed separately for the majority of the week.

Statistical analysis of changes in mother-infant interaction as assessed by the use of the Bethlem Mother-Infant Interaction Scale.

时间窗: End of therapy intervention - after approximately one year of therapy work in unit.

Statistical analysis of the quantitative data collected will be conducted by the researcher, via IBM SPSS Statistics software, using t-test and One-Way ANOVA analyses which will be applied to the questionnaires used weekly during the wait list and therapy intervention.

Statistical analysis of change in mental wellbeing as assessed by the use of Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

时间窗: End of therapy intervention - after approximately one year of therapy work in unit.

Statistical analysis conducted by the researcher, via IBM SPSS Statistics software, using Repeated Measures One-Way ANOVA and t-test to analyse the data collected from questionnaire used during the assessment phase and at the end of therapy engagement.

Measure any changes in mental wellbeing during the term of the Art Therapy intervention.

时间窗: Duration of therapeutic intervention within unit - approximately one year.

Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), 14 items - sensitive to changes in mental wellbeing at the individual level. This scale will be used once during the one week assessment and once at the end of the five week therapy engagement. The total score is obtained by summing the score for each of the 14 items. The scoring range for each item is from 1 - 5 and the total score is from 14-70. A score of 40 and below corresponded to probable depression and a score of 44 and below to possible depression.

Statistical analysis of change in patient reported quality of life as assessed by the use of ReQol20 (Recovering Quality of Life)

时间窗: End of therapy intervention - after approximately one year of therapy work in unit.

Statistical analysis of the quantitative data collected will be conducted by the researcher, via IBM SPSS Statistics software, using t-test and One-Way ANOVA analyses which will be applied to the questionnaires used during the assessment phase and at the end of therapy engagement.

Statistical analysis of change in patient reported quality of life as assessed by the use of ReQol10 (Recovering Quality of Life)

时间窗: End of therapy intervention - after approximately one year of therapy work in unit.

Statistical analysis of the quantitative data collected will be conducted by the researcher, via IBM SPSS Statistics software, using t-test and One-Way ANOVA analyses which will be applied to the questionnaires used weekly during the wait list and therapy intervention.

次要结局

  • Capture the participants lived experience of Art Therapy(End of therapy intervention with each client, approximately 6 weeks)
  • Measure participant interaction with art materials during Art Therapy intervention(Assessment phase only, first week of therapy, one week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Stanhope

Principal Investigator, Art Psychotherapist

University of Derby

研究点 (2)

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