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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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
Comparator / control treatment
Waitlist control. This group will be offered the treatment after the 3 month follow-up assessment.
Control group

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Homosexual, single, major relationship problems, male (expept partners of female participants)

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Name [1] 257525 0
Deakin university
Address [1] 257525 0
221 Burwood Hwy, Burwood, 3125, VIC
Country [1] 257525 0
Primary sponsor type
Deakin university
221 Burwood Hwy, Burwood, 3125, VIC
Secondary sponsor category [1] 256753 0
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
221 Burwood Hwy, Burwood, 3125, VIC
Ethics committee country [1] 259554 0
Date submitted for ethics approval [1] 259554 0
Approval date [1] 259554 0
Ethics approval number [1] 259554 0

Brief summary
This study aims to implement and evlaluate an internet-based cognitive-behavioural therapy program for females with sexual dysfunctions. It is anticipated that this study will increase treatment success and lower attrition rates by addressing the limitations of previous internet-based interventions and incorporating mindfulness techniques. Evaluation of the program will be conducted using data collected at pre-treatment, post-treatment and at a 3-month follow-up. A waitlist control group will be included for comparisons. This study will help to determine the efficacy of internet-based treatment options for female sexual dysfunctions and further elucidate the role of mindfulness in female sexual dysfunction interventions.
Trial website
Trial related presentations / publications
Public notes

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
Phone 14812 0
+61 (0)423046041
Fax 14812 0
Email 14812 0
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
Phone 5740 0
+61 (0)423046041
Fax 5740 0
Email 5740 0

No information has been provided regarding IPD availability
Summary results
No Results