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

NCT04107389 | Completed

• 1 other identifier: Stanhope 100491262
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perinatal Mental Health

Keywords

Art Psychotherapy; Art Therapy; Perinatal Mental Health; Mother and baby unit; Mental health and wellbeing; Pregnancy; Post-Partum; Creative Intervention; Randomised Control Trial; ReQol; WEMWBS

Outcome Measures

Primary Outcomes (8)

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

  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.

  Duration of therapeutic intervention within unit - approximately one year.

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

  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.

  Duration of therapeutic intervention within unit - approximately one year.

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

  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

  Duration of therapeutic intervention within unit - approximately one year.

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

  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.

  Duration of therapeutic intervention within unit - approximately one year.

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

Secondary Outcomes (2)

• 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

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Receives Art Therapy assessment and intervention

Behavioral: Art Psychotherapy, Art Therapy

Wait List Control Group

ACTIVE COMPARATOR

Added to wait list to receive intervention at a later date, participant is made aware of this

Behavioral: Wait List

Interventions

Art Psychotherapy, Art Therapy BEHAVIORAL

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.

Intervention Group

Wait List BEHAVIORAL

Wait list control group. Participants randomised to Wait List group or Intervention group.

Wait List Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Derby: lead

Study Sites (1)

The Beeches, Royal Derby Hospital Site

Derby, Derbyshire, DE22 3WQ, United Kingdom

Location

Related Links

• Hyland Moon, C. (2010). Materials and media in art therapy. New York, NY: Routledge

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Art Therapy; Waiting Lists

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Jamie Bird

  University of Derby

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Art Psychotherapist

Model Details: I intend to use a wait-list control group, whereby following admission to the unit, consenting patients will 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. This maximum six week term is based upon the six week average duration of patient stay within the unit.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 27, 2019
• Study Start: May 26, 2021
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)