None listed
Conditions
Brief summary
The current pilot study study aims to: 1) examine the effectiveness of an 8-session, 2-hour group, CBT and mindfulness intervention in reducing psychological distress and improving quality of life, 2) compare the efficacy of intervention delivery method (group versus self-instruction) and 3) produce a CBT and mindfulness treatment protocol that is evidence-based and cost-effective for both practitioners and clients. Women aged 18 years or over, who experience symptoms of endometriosis, will choose to participate in one of three groups: Group, Self-Instruction or Care as Usual (Open Label design).
Interventions
A Pilot Study Investigating Cognitive Behavioural Therapy (CBT) and Mindfulness Interventions for Endometriosis. There are two phases of the pilot study: Treatment Component and Research Component. There will be three participation levels (Group, Self-Instruction, Care as Usual) and participation will be determined in conjunction with the participant. The Group Intervention will occur in private practice locations within the Hobart CBD. The Focus Groups will occur at the University of Tasmania, College of Health and Medicine, School of Medicine (Division of Psychology), Sandy Bay campus. Activities completed by women engaged in the Self-Instruction or Care As Usual group will occur within a setting of the participant's choice (e.g., home). Phase 1: Treatment Component: Women who indicate a willingness to engage in the intervention will complete a brief screening interview with a registered Psychologist that will assess inclusion and exclusion criteria and suitability for psychological intervention. Women who meet the inclusion criteria for participation will be offered a choice of intervention level (Open Label Allocation). There is no out of pocket expense or gap fee payable for any participant regardless of intervention level (Group, Self-Instruction, Care as Usual). All participants will complete the pre-intervention, intervention interval, post intervention and six-month follow up assessments via Redcap, an online survey portal. The Group intervention will consist of 8 x 2 hour weekly CBT and mindfulness intervention sessions and 1 x 2 hour follow up session. The self-instruction group will receive the same 8 modules to be completed on a weekly basis. The Care as Usual group will not receive the treatment information but will complete the same weekly outcome measures, via an online portal, as the two intervention groups. The material covered in the CBT and mindfulness intervention will focus on perception and acceptance of a diagnosis of endometriosis 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 endometriosis 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 and assertive communication. The written and audio material used for the intervention will be designed specifically for the study. The intervention will be compiled and delivered by a registered Psychologist with extensive experience in CBT and Mindfulness interventions, Women's Health and Persistent Pain (10 years minimum experience). Intervention adherence will be monitored via completion of online assessment of the weekly content in the form of knowledge content and skills acquisition. Participants will also have an opportunity to provide written feedback regarding their use of materials presented in each module on a weekly basis. Participants who do not attend a scheduled session will be contacted via telephone to discuss nonattendance. Participants in the self-instruction or Care as Usual component will be contacted via telephone if they do not complete one of the scheduled assessments. Phase 2: Research Component: Women engaged in the treatment component will be provided with an opportunity to share their de-identified treatment outcome data with the researchers. They may also choose to take part in focus group discussions (group or individual) regarding their perception of the intervention. The research component will be conducted via the University of Tasmania, College of Health and Medicine, School of Medicine (Division of Psychology). The focus groups will occur two weeks following completion of the intervention and two weeks following the follow-up session. Women can choose to attend these face to face or provide written responses to the focus group questions.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants will be women, aged 18 years or over, who experience symptoms of endometriosis. Inclusion criteria for all women will include information regarding diagnostic classification (e.g., diagnostic category, disease stage/classification) and a referral letter completed by their general practitioner for treatment participation.
Exclusion criteria
Exclusion criteria for all women will be current engagement in group psychological treatment, 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.