Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000354785
Ethics application status
Approved
Date submitted
26/01/2022
Date registered
28/02/2022
Date last updated
28/02/2022
Date data sharing statement initially provided
28/02/2022
Date results information initially provided
28/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Behavioural and Art-based program (CB-ART):
A pilot study in an early parenting centre
Scientific title
Is CB-ART a useful resource for women admitted to an early parenting centre? A pilot study assessing feasibility, acceptability, safety and preliminary efficacy.
Secondary ID [1] 306282 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
CB-Art
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Mental Health
 325038 0
postnatal depression 325039 0
Condition category
Condition code
Mental Health 322471 322471 0 0
Depression
Reproductive Health and Childbirth 322472 322472 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-CB-Art intervention was offered over two, one-hour face to face group sessions held on day 2 and day 5 of a 5-day inpatient stay, for 3 participants at a time. The intervention was implemented with three independent groups at Masada Private Hospital Early Parenting Centre.
-Post enrollment in the study, attendance was checked off on a list for session 1 and session 2.
-Sessions were facilitated by a clinical psychologist and an assistant.
-Participants were provided with new art materials (A3 sheets of white paper, oil pastels, coloured pencils, grey lead pencils, charcoal and erasers) which were placed at the centre of a large oval table.
-During session one participants were instructed to draw an image associated with a personal source stress. They were given 10 uninterrupted minutes to work on the image
-Each participant was invited to talk about what had been drawn, and what they thought it meant to them, and then to respond to questions or comments from other group members.
-In session two participants were instructed to draw an image associated with a personal source of strength. They were given 10 minutes to complete the drawing. In the second session, participants were invited to respond to differences they observed between their own or others’ first and second drawings. Cognitive behavioural techniques were employed to assist participants to reframe thoughts and perceptions and to facilitate solution-focussed problem solving.
Intervention code [1] 322710 0
Treatment: Other
Comparator / control treatment
No control group.
Pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330251 0
Feasibility
Timepoint [1] 330251 0
Assessed by review of the field notes and study specific questionnaire completed over the phone one week post discharge.
Primary outcome [2] 330252 0
Acceptability
Evaluated from participant uptake and retention of participants.
Assessed by recruitment numbers and attrition rate.
Also during follow up one week post discharge with a study specific telephone interview.
Timepoint [2] 330252 0
Assessed at the recruitment phase. Ie the number of people approached regarding the study who participated.
Also assessed post completion of the follow up interview, conducted one week post discharge. At this time assessing for retention of participants.
Primary outcome [3] 330338 0
Safety
Participants were screened at the structured telephone follow up interview one week after discharge, Question addressed any harms or unpleasant components associated with participation in the program
Timepoint [3] 330338 0
One week post discharge
Secondary outcome [1] 405474 0
Change in Edinburgh Postnatal Depression score
Timepoint [1] 405474 0
Pre-intervention scores and post-intervention scores obtained one week post intervention and compared
Secondary outcome [2] 405861 0
Change in Short profile of emotional competence score
Timepoint [2] 405861 0
Pre-intervention scores and post-intervention scores obtained one week post intervention and compared
Secondary outcome [3] 405862 0
Discussion themes prompted by CB-Art intervention.
During session 1 and session 2 of CB-Art sessions field notes were recorded in the form of written documentation of key phrases that emerged in the discussion as well as the links to the images.
Timepoint [3] 405862 0
Assessed during session one and session 2.

Eligibility
Key inclusion criteria
Mothers admitted to Masada Private Hospital Early Parenting Centre.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot study using a single-centre, mixed-methods pre- and post- test design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean pre- and post-intervention scores were calculated and compared
Significance tests were not conducted because of the small sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/08/2015
Date of last participant enrolment
Anticipated
Actual
11/09/2015
Date of last data collection
Anticipated
Actual
18/09/2015
Sample size
Target
9
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21564 0
Masada Private Hospital - East St Kilda
Recruitment postcode(s) [1] 36476 0
3183 - East St Kilda

Funding & Sponsors
Funding source category [1] 310629 0
University
Name [1] 310629 0
Monash University
Country [1] 310629 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Global and Women’s Health
Address
School of Public Health and Preventive Medicine
Monash University
Level 4, 553 St Kilda Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 311915 0
None
Name [1] 311915 0
N/A
Address [1] 311915 0
N/A
Country [1] 311915 0
Other collaborator category [1] 282140 0
Other Collaborative groups
Name [1] 282140 0
Centre for Women's Health Studies
Address [1] 282140 0
Ben Gurion University of the Negev
Beer Sheva 84105
Country [1] 282140 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310232 0
The Avenue Hospital Human Research Ethics Committee
Ethics committee address [1] 310232 0
40 The Avenue
Windsor Victoria, 3181
Ethics committee country [1] 310232 0
Australia
Date submitted for ethics approval [1] 310232 0
15/05/2015
Approval date [1] 310232 0
23/06/2015
Ethics approval number [1] 310232 0
reference number 188

Summary
Brief summary
The period of pregnancy and early motherhood is a substantial life change associated with psychological turbulence. During this period, some women experience symptoms of anxiety and depression of sufficient severity to warrant professional psychological assistance. Psychosocial and psychological interventions are key therapeutic approaches for women at this life stage. There is growing evidence of the value of the arts in prevention and treatment of mental health problems. Evidence suggests that women prefer psychological interventions that provide social support and shared space for reflection.

Cognitive Behavioural and Art-based Intervention (CB-ART) is a novel therapy for prevention and treatment of perinatal mental health problems. The aim of this study was to implement and evaluate CB-ART for acceptability, feasibility, safety, and preliminary efficacy among women admitted to a residential early parenting unit.

The pilot study used a single-centre, mixed-methods pre- and post- test design to evaluate CB-ART among women admitted to a 5-day residential early parenting service in Melbourne, Australia. Participants completed questionnaires before and after attendance at two, one-hour CB-ART group sessions on day 2 and day 5 of admission during which field notes were taken. Evaluation interviews were conducted by telephone one week after discharge. The Short Profile of Emotional Competence and the Edinburgh Postnatal Depression Scale were used to assess emotional insight and symptoms of depression, respectively. Feasibility, acceptability and safety were assessed using an analysis of field notes, with quantitative data collected by telephone questionnaire and qualitative data by telephone interviews.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 116938 0
Dr Hilary Brown
Address 116938 0
School of Public Health and Preventive Medicine
Monash University
Level 4, 553 St Kilda Road
Melbourne VIC 3004
Country 116938 0
Australia
Phone 116938 0
+61 408384116
Fax 116938 0
Email 116938 0
hilary.brown@barwonhealth.org.au
Contact person for public queries
Name 116939 0
Dr Hilary Brown
Address 116939 0
School of Public Health and Preventive Medicine
Monash University
Level 4, 553 St Kilda Road
Melbourne VIC 3004
Country 116939 0
Australia
Phone 116939 0
+61 408384116
Fax 116939 0
Email 116939 0
hilary.brown@barwonhealth.org.au
Contact person for scientific queries
Name 116940 0
Dr Hilary Brown
Address 116940 0
School of Public Health and Preventive Medicine
Monash University
Level 4, 553 St Kilda Road
Melbourne VIC 3004
Country 116940 0
Australia
Phone 116940 0
+61 408384116
Fax 116940 0
Email 116940 0
hilary.brown@barwonhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14822Informed consent form    383470-(Uploaded-26-01-2022-14-13-21)-Study-related document.pdf
14825Ethical approval    383470-(Uploaded-26-01-2022-14-16-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.