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Trial registered on ANZCTR


Registration number
ACTRN12614001251617
Ethics application status
Not yet submitted
Date submitted
16/11/2014
Date registered
2/12/2014
Date last updated
1/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical controlled trial of the effectiveness of a psychological treatment program for separation anxiety disorder in adults.
Scientific title
In people with separation anxiety disorder, does the completion of a manualised psychological treatment program, compared to being on a waitlist control group, reduce the severity of separation anxiety symptoms and the level of impairment of the disorder in their day to day lives?
Secondary ID [1] 285616 0
nil
Universal Trial Number (UTN)
U1111-1163-8392
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
separation anxiety disorder 293537 0
Condition category
Condition code
Mental Health 293810 293810 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment comprises a new manualised psychological program specifically for separation anxiety disorder in adults. The therapy utilises techniques from cognitive behavioural therapy, attachment-related interventions and positive psychology. Participants in the intervention group will receive 8 weeks of individual treatment with an intern psychologist for one hour per week.
Intervention code [1] 290623 0
Treatment: Other
Comparator / control treatment
A waitlist control group, where participants receive no therapy for 8 weeks, and are tested for changes in severity of disorder or symptoms, prior to being offered treatment in a group setting.
Control group
Active

Outcomes
Primary outcome [1] 293600 0
Change in number and severity of separation anxiety disorder symptoms, as evidenced using the Adult Separation Anxiety Questionnaire (ASA-27), as well as the separation anxiety disorder section of the Composite International Diagnostic Interview (CIDI).
Timepoint [1] 293600 0
Immediately post-treatment.
Secondary outcome [1] 311446 0
Change in depression and anxiety, as evidenced using the Depression, Anxiety, Stress Scales (DASS-21), and change in ratings of disability in day to day life, as measured using the Sheehan Disability Scale.
Timepoint [1] 311446 0
Immediately post-treatment, and at 6 month follow-up.

Eligibility
Key inclusion criteria
Diagnosis of separation anxiety disorder.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary psychiatric diagnosis other than separation anxiety disorder, comorbid personality disorder, high distress requiring urgent intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to either the treatment or control groups will be done using a computer program to randomly allocate names to one of the two groups. This will take place after each person has been screened to determine if they are eligible to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation of participants to the treatment or control arms of the research will be done using a random number generating sequence in SPSS.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The expected 12-month prevalence rate of separation anxiety disorder in the population is 1.9%, as shown in the National Comorbidity Survey Replication, a population survey of 9282 respondents in the United States (Shear 2006).
The population of Randwick City area aged 18 or over is 76 169 (Australian Bureau of Statistics, 2011), suggesting an estimated pool of 1447 people in that area with separation anxiety disorder.
We aim to obtain a sample of 80 people with separation anxiety disorder over a period of two years (n = 40 in the treatment group, and n = 40 in the control group), which is feasible given this data.
In order to detect a 30% reduction in symptoms, we would need to be able to achieve an effect size of 0.64.
Johnston et al (2011), in a similar trial of psychological therapy, achieved moderate to large effect sizes ranging from .76 – 1.44 using a sample of 46 people in each of three groups (two treatment and one control group), while investigating the effectiveness of two different methods of administering psychological treatment for anxiety disorders. Thus a sample of 80 people (40 treatment and 40 control) should be sufficient to detect any differences between treatment and control groups with medium (0.5) to large effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2015
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8926 0
2032 - Kingsford

Funding & Sponsors
Funding source category [1] 290252 0
Self funded/Unfunded
Name [1] 290252 0
Country [1] 290252 0
Primary sponsor type
Individual
Name
Vijaya Manicavasagar
Address
Black Dog Institute, Hospital Rd, Prince of Wales Hospital, Randwick NSW 2032
Country
Australia
Secondary sponsor category [1] 288959 0
None
Name [1] 288959 0
Address [1] 288959 0
Country [1] 288959 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291951 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 291951 0
Ethics committee country [1] 291951 0
Australia
Date submitted for ethics approval [1] 291951 0
21/11/2014
Approval date [1] 291951 0
Ethics approval number [1] 291951 0

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

Contacts
Principal investigator
Name 52594 0
A/Prof Vijaya Manicavasagar
Address 52594 0
Black Dog Institute, Hospital Rd, Prince of Wales Hospital, Randwick NSW 2032
Country 52594 0
Australia
Phone 52594 0
+61 2 9382 4530
Fax 52594 0
+61 2 9382 8208
Email 52594 0
v.manicavasagar@unsw.edu.au
Contact person for public queries
Name 52595 0
Vijaya Manicavasagar
Address 52595 0
Black Dog Institute, Hospital Rd, Prince of Wales Hospital, Randwick NSW 2032
Country 52595 0
Australia
Phone 52595 0
+61 2 9382 4530
Fax 52595 0
+61 2 9382 8208
Email 52595 0
v.manicavasagar@unsw.edu.au
Contact person for scientific queries
Name 52596 0
Vijaya Manicavasagar
Address 52596 0
Black Dog Institute, Hospital Rd, Prince of Wales Hospital, Randwick NSW 2032
Country 52596 0
Australia
Phone 52596 0
+61 2 9382 4530
Fax 52596 0
+61 2 9382 8208
Email 52596 0
v.manicavasagar@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.