Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning

NCT06607835 | Completed DMC

• 1 other identifier: London Met Uni
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce vaginal pain during sexual intimacy among women post-gynaecological cancer treatment. Outcomes are also hoped to increase sexual functioning, well-being, sexual self-efficacy and quality of life. Research intention: If the combined mindful compassion and cannabis suppository intervention reduces vaginal pain and supports sexual and general well-being, then this research would be repeated on a larger scale targeting psychosexual services. A brief overview of the intervention: Mindfulness has been anecdotally discussed in reducing symptoms of vaginal pain and increasing overall well-being. A novel approach to pain management includes medical cannabis, which can be cannabidiol, tetrahydrocannabinol or both. Vaginal suppositories do not create a euphoric high in the same way as oral use, including inhalation. Quantitatively, randomisation will be based on whether participants use cannabis suppositories or not. This study does not randomise to cannabis groups owing to the legalities in the United Kingdom. Participants included eighty-three consenting participants. Of these, forty-one were using cannabis suppositories. The intervention was delivered for one month, and the follow-up was at twelve weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.

Conditions

Sexual Pain Disorders

Keywords

mindful-compassion; well-being; sexual self-efficacy; sexual functioning; cannabis suppositories

Outcome Measures

Primary Outcomes (5)

• The Short Warwick -Edinburgh Mental Well-being Scale

  This is a 7 item questionnaire with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha for the questionnaire is 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing. The Cronbach alpha in this study was 0.85.

  0, 4 and 12 weeks

• State Self-compassion Short Form

  This is a 12 item measure with 5 response categories, 1 = almost never to 5 = almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness versus. Self-judgement, common humanity versus isolation and mindfulness versus over-identification with painful thoughts and emotions. Reliability Cronbach alpha range between 0.68 and 0.78. The Cronbach alpha in this study was 0.73.

  0, 4 and 12 weeks

• The Female Sexual Function Index

  This is a 19 item measure of sexual pain, sexual desire, orgasm, lubrication, and sexual satisfaction with five response categories. The score range is 2.0 to 36.0 with 26.0 being the cut of for sexual dysfunction. Example questions include, Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration? and Over the past 4 weeks, how would you rate your level of discomfort or pain during or following vaginal penetration? Cronbach alpha for this questionnaire is .820 and higher. For the present study, the Cronbach alpha was .750.

  0, 4 and 12 weeks

• Sexual Self-Efficacy Scale for Female Sexual Functioning

  This is a 37 item measure which embraces aspects of female sexuality such as arousal, desire, orgasm, pain and satisfaction. This is a 10 response category. The score ranges of 0 to10, 11 to 20, and 21 to 30 and represent low, moderate, and high self-efficacy levels. Example questions include anticipating, thinking about, having intercourse without fear or anxiety and Engaging in intercourse without pain or discomfort. The Cronbach alpha is .930 for this questionnaire. For the present study, the Cronbach alpha was .852

  0, 4 and 12 weeks

• Brief Quality of Life Scale

  An 8 item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. This scale is scored by transforming the individual item scores from a 1 to 5 scale to a 0 to 100 scale. Example responses include how I view my life as necessary for my quality of life, and I am satisfied with my friends and friendship: The Cronbach alpha is .760 for this questionnaire. For the present study, the Cronbach alpha was .789.

  0, 4 and 12 weeks

Study Arms (2)

Online mindful-compassion weekly for four weeks

EXPERIMENTAL

Mindful compassion exercises

Behavioral: Mindful- compassion

Cannabis suppositories and online mindful-compassion for vaginal pain

EXPERIMENTAL

Cannabis suppositories and online mindful-compassion for vaginal pain

Behavioral: Mindful-compassion and cannabis suppositories

Interventions

Mindful- compassion BEHAVIORAL

Online mindful-compassion weekly for four weeks

Online mindful-compassion weekly for four weeks

Mindful-compassion and cannabis suppositories BEHAVIORAL

Cannabis suppositories and online mindful-compassion for vaginal pain

Cannabis suppositories and online mindful-compassion for vaginal pain

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were allocated to cannabis only, and cannabis adjunct groups would already be using cannabis suppositories.
• Must have engaged in vaginal sex within the last month
• Must be at least 6 months post cancer treatment
• Must be based in the United Kingdom
• Must have experienced sexual pain
• An absence of co-occurring difficulties
• Must be aged 18 years or older
• Must be able to read and write English.
• Patient health screening score must range between 0-9 mild
• Generalised anxiety disorder screening score must range between 0-9, mild

You may not qualify if:

• Have not attempted vaginal intercourse in the last month
• Have co-occurring difficulties
• Are still receiving cancer treatment or within 6 months of cancer treatment such as chemotherapy, surgery or radiation
• Aged below 18 years old
• Reading and writing English difficulties
• Not experiencing pain during vaginal sexual intercourse.
• Patient health screening score ranged between moderate to severe - 10-27
• Generalised anxiety screening score ranged between 10- 21.

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

School of Social Sciences and Professions

London, N7 8DB, United Kingdom

Location

Related Publications (6)

• Brotto LA, Yule M, Breckon E. Psychological interventions for the sexual sequelae of cancer: a review of the literature. J Cancer Surviv. 2010 Dec;4(4):346-60. doi: 10.1007/s11764-010-0132-z. Epub 2010 Jul 3.

  PMID: 20602188 RESULT

• Brotto LA, Erskine Y, Carey M, Ehlen T, Finlayson S, Heywood M, Kwon J, McAlpine J, Stuart G, Thomson S, Miller D. A brief mindfulness-based cognitive behavioral intervention improves sexual functioning versus wait-list control in women treated for gynecologic cancer. Gynecol Oncol. 2012 May;125(2):320-5. doi: 10.1016/j.ygyno.2012.01.035. Epub 2012 Jan 28.

  PMID: 22293042 RESULT

• Brotto LA, Stephenson KR, Zippan N. Feasibility of an Online Mindfulness-Based Intervention for Women with Sexual Interest/Arousal Disorder. Mindfulness (N Y). 2022;13(3):647-659. doi: 10.1007/s12671-021-01820-4. Epub 2022 Jan 4.

  PMID: 35035598 RESULT

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 RESULT

• Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

  PMID: 21584907 RESULT

• Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450.

  PMID: 4078907 RESULT

Study Officials

• Samantha Banbury, PhD

  London Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study phase is not applicable as whilst cannabis suppositories are part of this research study, participants are not randomised into cannabis groups. Participants would already be using cannabis suppositories for at least one month and are used as part of the individuals sexual intimacy. Randomisation was based on whether participants were using cannabis suppositories and consisted of one of four groups, including a cannabis suppository-only group, mindful- compassion only group, a combined mindful-compassion and cannabis suppository group and a care-as-usual group

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: July 2, 2023
• Primary Completion: October 1, 2023
• Study Completion: April 4, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)