Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000709044
Ethics application status
Not yet submitted
Date submitted
24/08/2010
Date registered
26/08/2010
Date last updated
26/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Incorporating mindfulness into an internet-based intervention for female sexual dysfunctions.
Scientific title
Increasing sexual functioning (desire, arousal, orgasm, satisfaction, lack of pain) in heterosexual women in stable relationships with an internet-based cognitive-behavioural therapy intervention: randomised controlled trial of efficacy.
Secondary ID [1] 252561 0
NA
Universal Trial Number (UTN)
U1111-1116-6922
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female sexual dysfunctions (disorders of desire, arousal, orgasm and pain) 258043 0
Condition category
Condition code
Mental Health 258205 258205 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Internet-based cognitive-behavioural therapy program consisting of 6 modules. Each module will take approximately 30 minutes to read and will then include behavioural homework to complete over the next fortnight (approximately). Each module will involve psychoeducation, sensate focus, communication exercises, cognitive exercises and mindfulness techniques. Unlimited email contact will also be available and fortnightly web-based chat groups will occur to discuss progress and relevant issues.
Intervention code [1] 257079 0
Treatment: Other
Intervention code [2] 257094 0
Behaviour
Comparator / control treatment
Waitlist control. This group will be offered the treatment after the 3 month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 259068 0
Sexual functioning (desire, arousal, orgasm, satisfaction, pain) as measured by the Female Sexual Function Index (Rosen et al., 2000) with recommended alterations (Meyer-Bahlburg & Dolezal, 2007), and the Female Sexual Distress Scale to measure associated distress.
Timepoint [1] 259068 0
Pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [1] 265335 0
Relationship functioning using the Personal Assessment of Intimacy in Relationships Scale (Schaefer & Olson, 1981) and the Sexual Function Scale (McCabe, 1998).
Timepoint [1] 265335 0
Pre-treatment, post-treatment, 3-month follow-up

Eligibility
Key inclusion criteria
Heterosexual females experiencing at least one sexual dysfunction, over 18 years, in a stable relationship and their parters (partners used for sexual dysfunction screening only)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Homosexual, single, major relationship problems, male (expept partners of female participants)

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)
Subjects will be screened online prior to allocation and then central randomisation from intervention website will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation from intervention website
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2831 0
New Zealand
State/province [1] 2831 0
Country [2] 2832 0
United States of America
State/province [2] 2832 0
Country [3] 2833 0
United Kingdom
State/province [3] 2833 0

Funding & Sponsors
Funding source category [1] 257525 0
University
Name [1] 257525 0
Deakin university
Country [1] 257525 0
Australia
Primary sponsor type
University
Name
Deakin university
Address
221 Burwood Hwy, Burwood, 3125, VIC
Country
Australia
Secondary sponsor category [1] 256753 0
None
Name [1] 256753 0
Address [1] 256753 0
Country [1] 256753 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259554 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 259554 0
Ethics committee country [1] 259554 0
Australia
Date submitted for ethics approval [1] 259554 0
06/09/2010
Approval date [1] 259554 0
Ethics approval number [1] 259554 0

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

Contacts
Principal investigator
Name 31565 0
Address 31565 0
Country 31565 0
Phone 31565 0
Fax 31565 0
Email 31565 0
Contact person for public queries
Name 14812 0
Alice Hucker
Address 14812 0
Deakin Univeristy, School of Psychology, 221 burwood Highway, Burwood, 3126, VIC
Country 14812 0
Australia
Phone 14812 0
+61 (0)423046041
Fax 14812 0
Email 14812 0
[email protected]
Contact person for scientific queries
Name 5740 0
Alice Hucker
Address 5740 0
Deakin Univeristy, School of Psychology, 221 burwood Highway, Burwood, 3126, VIC
Country 5740 0
Australia
Phone 5740 0
+61 (0)423046041
Fax 5740 0
Email 5740 0
[email protected]

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.