Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000843853
Ethics application status
Approved
Date submitted
27/05/2021
Date registered
1/07/2021
Date last updated
21/06/2022
Date data sharing statement initially provided
1/07/2021
Date results provided
19/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy and Acceptability of a Remotely Delivered Transdiagnostic Cognitive Behavioural Therapy (CBT) Treatment for Perinatal Anxiety: A Case Series
Scientific title
The Efficacy and Acceptability of a Remotely Delivered Transdiagnostic CBT Treatment for Perinatal Anxiety in Women up to Ten Months Postpartum: A Case Series
Secondary ID [1] 300124 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal anxiety
 315661 0
Condition category
Condition code
Mental Health 313952 313952 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment will consist of 5 x 50 minute weekly CBT sessions, which will be conducted via the secure online platform, Zoom. Sessions will be recorded for quality and supervision purposes. The intervention will be delivered via the student researcher, Peta Maguire, who is a registered psychologist. Participants will be required to complete weekly brief questionnaires so that the clinician can monitor participants symptoms. The session outline for the treatment is below:

Session 1: Psychoeducation
• Psychoeducation
• Developing a CBT model
• Homework: Symptom Monitoring Diary

Session 2: Cognitive Restructuring
• Homework check-in
• Introduction to automatic thoughts
• Identifying and challenging unhelpful automatic thoughts
• Homework: Unhelpful Thinking Worksheet

Session 3: Arousal Reduction
• Homework check-in
• Controlling physical symptoms using de-arousal strategies
• Homework: Arousal reduction strategies

Session 4: Exposure
• Homework check-in
• Identifying maladaptive behaviours
• Education about graded exposure
• Constructing an exposure stepladder
• Homework: Graded exposure task

Session 5: Relapse Prevention
• Homework check in
• Developing a relapse prevention plan
• Extra resources
Intervention code [1] 316405 0
Treatment: Other
Intervention code [2] 316406 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322426 0
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) - diagnostic clarification
Timepoint [1] 322426 0
Pre-treatment, post-treatment, 3 month follow up
Primary outcome [2] 322427 0
The Overall Anxiety Severity and Impairment Scale (OASIS) - mean OASIS score
Timepoint [2] 322427 0
Pre-treatment, weekly, post-treatment, 3 month follow up
Primary outcome [3] 322428 0
The Edinburgh Postnatal Depression Scale (EPDS) - mean EPDS score
Timepoint [3] 322428 0
Pre-treatment, weekly, post-treatment, 3 month follow up
Secondary outcome [1] 378494 0
The Maternal Postnatal Attachment Scale (MPAS) - mean score on MPAS
Timepoint [1] 378494 0
Administered pre-treatment, post-treatment, 3 month follow up
Secondary outcome [2] 378495 0
The Karitane Parenting Confidence Scale (KPCS) - mean KPCS score
Timepoint [2] 378495 0
Pre-treatment, post-treatment, 3 month follow up
Secondary outcome [3] 378496 0
The Kessler 10-Item Psychological Distress Scale (K-10) - mean K-10 score
Timepoint [3] 378496 0
Pre-treatment, post-treatment, 3 month follow up

Eligibility
Key inclusion criteria
(a) Currently in the first 10 months postpartum (participants must be within 10 months postpartum to ensure treatment is delivered during the perinatal period);
(b) Proficient in English;
(c) 18 years of age or above;
(d) Have regular access to the internet;
(e) Meet DSM-5 diagnostic criteria for an anxiety or related disorder as primary (as determined by the DIAMOND);
(f) No history of psychotic illness or bipolar disorder;
(g) A score of at least 8 on the Overall Anxiety Severity and Impairment Scale (OASIS)
(h) If using medication, the medication is a stable dose
(i) Does not report suicidal ideation and intent (as identified through risk related questions during interview)
(j) Does not report recent (i.e., past 3 months) suicide attempts or deliberate self-harm
(k) Does not report past or present psychosis (assessed using the DIAMOND)
(l) A score of below 3 on item 10 of the Edinburgh Postnatal Depression Scale (EPDS)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Currently not in the first 10 months postpartum
(b) Not proficient in English
(c) Under 18years of age
(d) Do not have regular access to the internet
(e) Does not endorse one of the anxiety and related disorders on the DIAMOND screener
(f) History of a psychotic illness or bipolar disorder
(g) Does not have a score of at least 8 on the Overall Anxiety Severity and Impairment Scale (OASIS)
(h) Not on a stable dose of pharmacological medication
(i) Report suicidal ideation and intent (as identified through risk related questions during interview).
(j) Recent (i.e., past 3 months) suicide attempts or deliberate self-harm
(k) Report past or present psychosis (assessed using the DIAMOND)
(l) Are at high risk of suicide as determined by a score of 3 on item 10 of the Edinburgh Postnatal Depression Scale (EPDS).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS. The OASIS, EPDS, PHQ-9, and CSQ will be scored based on the method described in each individual questionnaires protocol. Data will be collected at pre-intervention (baseline, T1), post-intervention (T2), and 3-month follow-up (T3) and will be reported and examined using visual inspection of graphs. Clinically significant change will be calculated according to the method outlined by Jacobson and Truax (1991). Descriptive data (95% confidence intervals; means and standard deviations) will be used to describe the pooled participant outcomes at pre-treatment, post-treatment, and three month follow up).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2021
Actual
29/07/2021
Date of last participant enrolment
Anticipated
30/11/2021
Actual
3/11/2021
Date of last data collection
Anticipated
1/04/2022
Actual
4/03/2022
Sample size
Target
6
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304564 0
University
Name [1] 304564 0
University of New England
Country [1] 304564 0
Australia
Primary sponsor type
University
Name
University of New England
Address
University of New England
Armidale NSW 2351
Australia
Country
Australia
Secondary sponsor category [1] 305274 0
None
Name [1] 305274 0
Address [1] 305274 0
Country [1] 305274 0
Other collaborator category [1] 281422 0
University
Name [1] 281422 0
The University of Technology Sydney
Address [1] 281422 0
The University of Technology Sydney
Ultimo, NSW 2007
Australia
Country [1] 281422 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304990 0
University of New England Human Research Ethics Committee (HREC)
Ethics committee address [1] 304990 0
Ethics committee country [1] 304990 0
Australia
Date submitted for ethics approval [1] 304990 0
18/12/2020
Approval date [1] 304990 0
21/01/2021
Ethics approval number [1] 304990 0
HE20-218

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98882 0
A/Prof Navjot Bhullar
Address 98882 0
University of New England
Armidale NSW 2350
Australia
Country 98882 0
Australia
Phone 98882 0
+61267733187
Fax 98882 0
Email 98882 0
[email protected]
Contact person for public queries
Name 98883 0
Peta Maguire
Address 98883 0
University of New England
Armidale NSW 2350
Australia
Country 98883 0
Australia
Phone 98883 0
+61 412879003
Fax 98883 0
Email 98883 0
[email protected]
Contact person for scientific queries
Name 98884 0
Peta Maguire
Address 98884 0
University of New England
Armidale NSW 2350
Australia
Country 98884 0
Australia
Phone 98884 0
+61 412879003
Fax 98884 0
Email 98884 0
[email protected]

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
6850Study protocol    Attached 378956-(Uploaded-30-07-2021-15-47-00)-Study-related document.docx
10638Ethical approval    Attached 378956-(Uploaded-27-05-2021-08-11-40)-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
SourceTitleYear of PublicationDOI
EmbaseFeasibility and acceptability of a remotely delivered transdiagnostic CBT treatment for postnatal anxiety and related disorders: A pilot case series.2023https://dx.doi.org/10.1177/17455057231175800
N.B. These documents automatically identified may not have been verified by the study sponsor.