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Trial registered on ANZCTR


Registration number
ACTRN12620001291976p
Ethics application status
Submitted, not yet approved
Date submitted
23/10/2020
Date registered
30/11/2020
Date last updated
30/11/2020
Date data sharing statement initially provided
30/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study Investigating Cognitive Behavioural Therapy (CBT) and Mindfulness Interventions for Women Living with Persistent Pelvic Pain.
Scientific title
A Pilot Study Investigating Cognitive Behavioural Therapy (CBT) and Mindfulness Interventions for Women Living with Persistent Pelvic Pain.
Secondary ID [1] 302612 0
None
Universal Trial Number (UTN)
U1111-1260-0875
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Pelvic Pain 319501 0
Condition category
Condition code
Mental Health 317461 317461 0 0
Other mental health disorders
Renal and Urogenital 317793 317793 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of group-based psychological therapy sessions facilitated by a psychologist. The group program will involve attendance at eight weekly CBT and Mindfulness therapy sessions of 2 hours duration. Allocation will be open choice (group program, care as usual). The material covered in the CBT and mindfulness intervention will be based on the program developed by Van Niekerk, Matthewson, and Richardson (2018) for women living with endometriosis. The pre-existing program materials will be modified to focus on the broader range of persistent pelvic pain presentations (e.g., vaginismus, vulvodynia) and will be modified to reflect participant feedback from the clinical trial currently being conducted by Van Niekerk et al. (2018). The materials will focus on perception and acceptance of a diagnosis of persistent pelvic pain with special attention paid to the experience of pain and loss of personal, relational, sexual and occupational functioning. Interventions will aim to improve health-related quality of life and to decrease psychological distress. Intervention areas have been chosen based on their pertinence for inclusion in therapy based on the known symptoms associated with persistent pelvic pain including activity and fatigue; anxiety/stress; depression; relationships; vocational/occupational/social engagement; pain management; acceptance and mindfulness. Specific skills that will be addressed in the interventions include, but are not limited to, relaxation skills training, behavioural activation and experiments, cognitive restructuring, goal setting, pacing, habit reversal, stimulus control, assertive communication and self/body compassion. Adherence to CBT will be monitored through session checklists and session knowledge quiz completed at the end of each session.
Intervention code [1] 318894 0
Behaviour
Intervention code [2] 318895 0
Treatment: Other
Intervention code [3] 318896 0
Diagnosis / Prognosis
Comparator / control treatment
Women waiting to engage in the group intervention will be categorised as a Care as Usual group and complete the same pilot study assessment battery as those receiving intervention. Women in the Care as Usual group do not receive any intervention materials and continue to engage in the same treatment pathways as they were engaged in prior to commencing the 8-week care as usual time period. Information will be gathered regarding any change to their treatment during the 8-week period (e.g., medication changes, therapy engagement, surgery).
Control group
Active

Outcomes
Primary outcome [1] 325493 0
Quality of Life
Disease-specific and generalised measures of QOL will be used to provide a composite score. The Endometriosis Health Profile (EHP-30) is a health- related quality-of-life (HRQoL) questionnaire developed to specifically address the impact of the disease on the physical, psychological, and social aspects of women’s lives. The Short-Form Health Survey (SF-36) is a 36-item multi-purpose short-form health survey that produces an 8-scale functional health profile. Subscale scores can be obtained for Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). The AQoL-8D multi-attribute utility instrument captures and assesses psychosocial health states. The AQoL-8D and SF-6D (designed to measure the cost effectiveness of health interventions) have been used in other areas of complex and chronic disease and for Australian cohorts (including access of healthcare services). These instruments will be used in this study to assess the health impact of the project’s intervention for women living with PPP. A general quality of life measure is used to generalise across the different forms of persistent pelvic pain as not all pain forms have a unique QOL measure.
Timepoint [1] 325493 0
Baseline (prior to engagement in group intervention), Posttreatment (within 7 days of completion of the final intervention session) and at six-month follow-up.
Primary outcome [2] 325494 0
Psychological Health - Composite score
The PROMIS Emotional Distress Short Form is an 8-item measure that focuses on affective and cognitive manifestations of depression in individual aged 18 years and over. The individual is asked to rate the severity of symptoms of depressed mood, during the past 7 days, on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). Scores range from 8 to 40 with higher scores indicating greater severity of depression. The 7-item PROMIS Anxiety Short Form assesses anxiety in individuals aged 18 and over. The respondent rates the severity of their anxiety during the past 7 days. Items are rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35. Higher scores indicate a greater severity of anxiety. The Physical Health Symptoms (PHQ-15) assesses the domain of somatic symptoms. The measure contains 15 items and each item on the PHQ-15 is rated on a 3-point scale (0=not bothered at all; 1=bothered a little; 2= bothered a lot). The total score ranges from 0 to 30, with higher scores indicating greater severity of somatic symptoms.
Timepoint [2] 325494 0
Baseline (prior to engagement in group intervention), Weekly Interval during group engagement, Posttreatment (within 7 days of completion of the final intervention session) and at six-month follow-up.
Secondary outcome [1] 388153 0
Pain Intensity
Visual Analogue Scales will be used to record pain ratings during the intervention. The participant marks a point on a 10-cm line to indicate their current pain intensity, which can be measured in millimetres to yield a 101-point scale. The VAS provides a high degree of resolution and is probably the most sensitive single-item measure for clinical pain research.
Timepoint [1] 388153 0
Baseline (prior to engagement in group intervention), Weekly Interval during group engagement, Posttreatment (within 7 days of completion of the final intervention session) and at six-month follow-up.
Secondary outcome [2] 388154 0
Change in Capacity to use Mindfulness to Manage Emotions
The Cognitive and Mindfulness Scale, revised (CAMS-R) was designed to measure mindfulness in a brief, jargon-free, and conceptually comprehensive way, with the intention that it would be a generic measure appropriate regardless of meditation experience.
Timepoint [2] 388154 0
Baseline (prior to engagement in group intervention), Weekly Interval during group engagement, Posttreatment (within 7 days of completion of the final intervention session) and at six-month follow-up.
Secondary outcome [3] 389288 0
Pain Interference
The West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) is designed to provide a brief, psychometrically-sound, and comprehensive assessment of the important components of persistent pain and is focused on the cognitive behavioural aspects of the pain experience. It measures perceived interference of pain, support or concern from spouse or significant others, pain severity, perceived life control, and affective distress.
Timepoint [3] 389288 0
Baseline (prior to engagement in group intervention) and at six-month follow-up.
Secondary outcome [4] 389289 0
Pain Coping
The Coping Strategies Questionnaire (CSQ-24) will be used to measure cognitive and behavioural pain coping strategies.
Timepoint [4] 389289 0
Baseline (prior to engagement in group intervention) and at six-month follow-up.
Secondary outcome [5] 389290 0
Pain Catastrophising
The Pain Catastrophising Scale (PCS) was developed to help quantify an individual's pain experience, asking about how they feel and what they think about when they are in pain. Compared to other ways of measuring pain-related thoughts, this questionnaire is unique in that the individual does not need to be in pain while completing it. It is one of the most widely used instruments for measuring catastrophic thinking related to pain, and is used extensively in clinical practice and in research.
Timepoint [5] 389290 0
Baseline (prior to engagement in group intervention) and at six-month follow-up.
Secondary outcome [6] 389291 0
Self-Efficacy of Emotions
The Self-Efficacy for Managing Emotions (short-Form) assesses an individual’s level of confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger. Items also explore the presence of strategies to manage stress and loss.
Timepoint [6] 389291 0
Baseline (prior to engagement in group intervention), Weekly Interval during group engagement, Posttreatment (within 7 days of completion of the final intervention session) and at six-month follow-up.

Eligibility
Key inclusion criteria
Women, aged 18 years or over, who experience symptoms of persistent pelvic pain, waitlisted for the Royal Hobart Hospital Persistent Pelvic Pain Clinic. Inclusion criteria for all women will include information regarding diagnostic classification (e.g., diagnostic category, disease stage/classification) and a confirmed diagnosis of persistent pelvic pain provided by the RHH Gynaecology staff.
Minimum age
18 Years
Maximum age
47 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for all women will be current engagement in group psychological treatment, unconfirmed diagnosis of persistent pelvic pain, current experience of psychosis, substance abuse, mania, or suicidal ideation and intent. Women with significant cognitive deficits will also be excluded due to the ethical requirements of informed consent and a potential inability to self-select and due to the cognitive nature of the specific interventions. Pregnant women will be excluded to minimise the possibility of an inability to complete the program due to pregnancy-related factors. However, due to ethical and professional duty of care, women who conceive while completing the program will be able to continue.

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)
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
Data will be analysed to assess changes in mean scores at baseline, treatment interval, post-treatment and follow-up. Reliable Change Index (Jacobson, Follette, & Revenstorf, 1984) will be used to analyse the data. RCI measures whether the change in measured outcomes pre and post intervention is statistically significant and unlikely to be due to simple measurement unreliability. The following formula will be used: SD1*sqrt(2)*sqrt(1-rel), where SD1 is the initial standard deviation, sqrt indicates the square root and rel indicates the reliability. For this study, test-retest reliability of the measures used will be used in the formula. This methodological approach has been chosen at it addresses the research deficiencies identified and allows for a quantitative measure of clinical change as a result of the intervention. Participants in the two intervention delivery modes will be matched using matched pairs. It is expected pairing will be based on age, educational and professional status, socio-demographic status, parity and stage of disease. Baseline, Treatment Interval, Posttreatment assessments and a Six-Month follow-up will allow for review of treatment efficacy and maintenance. Confounding factors will be accounted for by gathering disease-specific diagnosis, severity and treatment information. It is anticipated that mixed models with repeated measures will be used. The dependent variables will be the outcome measures. Fixed Independent variables will include Intervention Level (Group, Care as Usual) and Time (Preassessment, Treatment Interval, Postassessment, Follow-up). Participant variables (e.g., disease stage, socioeconomic status) will be controlled for. Outcomes will be measured via quantitative changes in QoL (SF-36, SF-6D, AQoL-8D), psychological function (PROMIS), pain coping and function (Visual Analogue scales; Pain Coping Scale). Focus groups will also be used to provide qualitative outcomes regarding reduction in healthcare utilisation and an increase in function and engagement in social, occupational, and personal settings.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 18087 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 32076 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 307042 0
University
Name [1] 307042 0
University of Tasmania
Address [1] 307042 0
University of Tasmania
College of Health and Medicine
School of Psychological Sciences
Private Bag 30
HOBART TAS 7001
Country [1] 307042 0
Australia
Funding source category [2] 307044 0
Hospital
Name [2] 307044 0
Royal Hobart Hospital
Address [2] 307044 0
48 Liverpool Street
Hobart TAS 7000
Country [2] 307044 0
Australia
Funding source category [3] 307045 0
Charities/Societies/Foundations
Name [3] 307045 0
Royal Hobart Hospital Research Foundation
Address [3] 307045 0
GPO Box 1061
Hobart Tasmania 7001
Country [3] 307045 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
University of Tasmania
College of Health and Medicine
School of Psychological Sciences
Private Bag 30
HOBART TAS 7001
Country
Australia
Secondary sponsor category [1] 307610 0
None
Name [1] 307610 0
Address [1] 307610 0
Country [1] 307610 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307169 0
University of Tasmania, Health and Medical Research Committee
Ethics committee address [1] 307169 0
University of Tasmania
Office of Research Services
Private Bag 1, Hobart, TAS, 7001
Ethics committee country [1] 307169 0
Australia
Date submitted for ethics approval [1] 307169 0
02/11/2020
Approval date [1] 307169 0
Ethics approval number [1] 307169 0

Summary
Brief summary
The current pilot study study aims to examine the effectiveness of an 8-session, 2-hour group, CBT and mindfulness intervention in reducing psychological distress and improving quality of life for women living with persistent pelvic pain. Women aged 18 years or over, who experience symptoms of persistent pelvic pain, will choose to participate in small group therapy intervention or Care as Usual levels (Open Label design).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106274 0
Dr Leesa Van Niekerk
Address 106274 0
University of Tasmania
College of Health and Medicine
School of Psychological Sciences
Private Bag 30
HOBART TAS 7001
Country 106274 0
Australia
Phone 106274 0
+61 362266645
Fax 106274 0
Email 106274 0
Leesa.Vanniekerk@utas.edu.au
Contact person for public queries
Name 106275 0
Dr Leesa Van Niekerk
Address 106275 0
University of Tasmania
College of Health and Medicine
School of Psychological Sciences
Private Bag 30
HOBART TAS 7001
Country 106275 0
Australia
Phone 106275 0
+61 362266645
Fax 106275 0
Email 106275 0
Leesa.Vanniekerk@utas.edu.au
Contact person for scientific queries
Name 106276 0
Dr Leesa Van Niekerk
Address 106276 0
University of Tasmania
College of Health and Medicine
School of Psychological Sciences
Private Bag 30
HOBART TAS 7001
Country 106276 0
Australia
Phone 106276 0
+61 362266645
Fax 106276 0
Email 106276 0
Leesa.Vanniekerk@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent relates to the provision of de-identified data to the researchers outlined on the participant consent form. The researchers do not have consent to share raw data for other purposes.
What supporting documents are/will be available?
No other documents available
Summary results
No Results