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A Pilot Study Investigating Cognitive Behavioural Therapy (CBT) and Mindfulness Interventions for Women Living with Persistent Pelvic Pain.

A Pilot Study Investigating Cognitive Behavioural Therapy (CBT) and Mindfulness Interventions for Women Living with Persistent Pelvic Pain.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001291976
Enrollment
120
Registered
2020-11-30
Start date
2021-02-01
Completion date
2021-12-31
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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 ma

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.

Sponsors

University of Tasmania
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 47 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026