The protocol must use these headings (if applicable) and contain the information requested. Additional headings can be added if necessary and it is expected all potential ethical issues are disclosed. The protocol should be approximately 2-3 sides of A4 for studies with no significant ethical concerns and approximately 4-5 sides of A4 for studies with significant ethical concerns. The protocol structure aligns with the research ethics toolkit (Li, et al. 2016), which is a framework for protocol writers to use when applying for research ethics.
Reference:
Li R., et al. 2016. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. Journal of Medical Ethics, 42(4), pp. 229-234.
Study title: How do Counselling Psychologists tailor therapeutic interventions towards the unique sociocultural context of LGBTQ+ individuals?
Short title (optional):
Introduction:
• Background to the study and relevant literature.
• What is the scientific and/or theoretical justification for the study.
Extant studies have suggested that sexual orientation constitutes a social determinant of mental health (Fox et al., 2020; Bidell, 2016; Hunt, 2014; Magyar-Moe et al., 2015; Pepping et al., 2018; Roughley and Morrison, 2013; Walker and Prince, 2010). Lesbian, Gay, Bisexual, Transgender, Queer, or Questioning individuals experience stigma-related prejudice, social isolation, and discrimination, which has been associated with poor mental health and stress (Kelleher, 2009). These mental stresses can culminate in adverse health outcomes (Kelleher, 2009). LGBTQ+ individuals experience unique mental health disparities compared to heterosexual and cisgender groups (Mink et al., 2014; Berke et al., 2016). These disparities provide a strong case for sexual minority mental health research (Mink et al., 2014). Despite this, the LGBTQ+ literature has tended to draw upon heterosexual and cisgender groups as benchmarks of mental health; the tenor of such research has undermined opportunities to understand the unique experiences and mental health needs of LGBTQ+ individuals in both training and practice (Lytle et al., 2014). There is an increasing demand for culturally competent interventions; however, significant literature gaps continue to exist. Literature concerning how Counselling Psychologists may tailor mental health interventions towards the unique sociocultural context of LGBTQ+ individuals is significantly lacking. Thus, due to the existing research gaps, this proposed study focuses on Counselling Psychologists’ responses to tackling mental stresses in patients identifying as LGBTQ+.
There is a notable lack of research concerning Counselling Psychology interventions for LGBTQ+ individuals. Studies relating to positive psychology, psychotherapy, and family-based therapy exist. However, for the most part, these are not practice-oriented or do not go into detail about the efficacy of such interventions. Notable studies include that of Lytle et al. (2014), which provided an account of how positive psychology may be applied to address the mental health needs of LGBTQ+ patients effectively. Although the study was based on a secondary literature review, it provided comprehensive insight into integrative frameworks for practice with clients’ demography. The study also discussed possible pathways for incorporating communities and other social institutions into practice. This study was not evidence-based and, for the most part, provided recommendations for clinical practice based on the analysis of existing gaps. In a study by Berke et al. (2016), the scholars employed qualitative research methods to investigate the experiences of LGBTQ+ individuals in psychotherapy. The research found that interpersonal connectedness and authentic affirmation play a crucial role in an individual’s mental health sense (Berke et al., 2016). The research also established multiple and intersecting axes of identity shaping participant experiences of psychotherapy (Berke et al., 2016). Willging et al. (2016) implemented a community, coaching-based intervention to address the mental health needs of LGBTQ+ individuals in rural areas. As part of the study, peer advocates received coaching training by licensed mental health professionals and evaluated the process using iterative qualitative analysis. The research showed that the intervention helped alleviate the mental distress of the research participants. This research aligns with Diamond et al. (2012), although this study focused on attachment-based family therapy to address mental stress in LGBTQ+ individuals. The study found that this approach had high efficacy for reducing suicidal ideation amongst LGBTQ+ individuals.
Study aim(s):
• Specify the study question(s) or hypothesis(es).
• The question(s) or hypothesis(es) should link to the scientific and theoretical justification provided in the introduction.
a. What methods are currently available on the type of therputic interventions for LGBTQ+ individuals with mental health needs?
b. How does Counselling Psychology practice support mental stress treatment for LGBTQ+ individuals?
c. What is the efficacy of current interventions and what are the implications for practice and policy?
d. How do current interventions inform future priorities for research?
Study design and methods:
• Name the study design being used (e.g. RCT, single-case design, grounded theory).
• State the location where study will take place (e.g. online, or NHS).
• Describe any intervention(s) and/or study procedure(s) (e.g. motivational interviewing, exercise bike).
• Explain how data will be collected (e.g. online survey, interviews).
• Attach copies of any data collection tools being used (e.g. PHQ9, MMSE).
• Specify the length of time participants will be involved in the study (e.g. two half hour appointments in July 2019).
Qualitative research methods
Location: online
Data will be collected through semi-structured interviews – Counselling Psychologists will be interviewed online
30 minute interview?
Data management:
• Will the study collect data (or personal data)?
• What data (or personal data) will be collected (e.g. names, matric number)?
• Who will collect data (or personal data)?
• Who will have access to data (or personal data)?
• How will data (or personal data) be used?
• Where and how will data (or personal data) be stored (e.g. on a password protected computer drive)?
• When and by whom will anonymisation occur?
• When and how will data (or personal data) be destroyed (e.g. confidentially after five years)?
• Will the study adhere with university data security and data protection/GDPR legislation?
Female or male
Age
Counselling Psychologists approved by HCPC.
etc
Choice of control group and standard care (if applicable):
• Will the study use a control group?
• What will participants in the control group receive (e.g. usual care)?
Inclusion and exclusions criteria:
• List inclusion criteria (e.g. adult, student, living with long-term condition).
• List exclusions criteria (e.g. child, pregnant, currently on sick leave from work).
Recruitment of participants:
• Anticipated sample size (e.g. 5 participants).
• Sampling method (e.g. convenience).
• Recruitment methods and copies of any advertisements/emails (e.g. social media, posters).
• Who will make first contact with potential participants (e.g. the gatekeeper)?
• How will the first approach to potential participant be made (e.g. email sent by gatekeeper)?
• Will potential participants be asked more than once to participate (e.g. a reminder email will be sent after four week)?
Counselling Psychologists using the list of chartered members on HCPC website.
Sample size – this can be a range, small enough to be manageable, large enough to give you a good chance of finding good information and seeing patterns. For qualitative anything up to about 10 should be fine for a student project, but see if you can find a reference to support your no.
Sampling method – convenience; or purposive as you’ll be targeting a very specific group of people who have a common experience
Recruitment methods / First contact / First approach – is the list of chartered members public? If not, you will need permission of whoever controls the list to use it for recruitment. Alternatively, you can use personal contacts, social media & social networks, word of mouth, snowballing, mailing lists (with permission), etc. For these Qs, have a think about access/permission and then just be honest and clear about what you plan to do.
Consent:
• When and how will potential participants learn about the study?
• When and how will potential participants receive the participant information sheet?
• When and how will potential participants be able to ask questions?
• Will written consent be used?
• When and how will consent be secured?
• Who will be responsible for securing informed consent prior to starting the study?
• Will participants be told they can withdraw from the study?
Ethics Consent Form 2020
Participant Information Sheet
Sent via email
Possible harms:
• What possible harms does the study pose for participants and/or the study team?
Steps taken to mitigate possible harms:
• How are the possible harms being mitigated by the study team?
• Is debriefing being offered to participants and/or the study team?
• Are safety procedures in places to support participants and/or the study team?
Possible benefits:
• What are the possible benefits associated with participating in the study?
Community engagement (if applicable):
• Does the study include any patient and/or public engagement (e.g. yes/no)?
• How will patient and/or the public be involved in the study (e.g. dissemination of findings)?
Return of results and incidental findings (if applicable):
• Will the study team notify participants of any important health related findings (e.g. high blood pressure)?
• Will the study team signpost the participants to their General Practitioner, if they find any concerning health related information?
• What steps will the study team take if a participant discloses professional misconduct and/or poor practice during the study?
• Will participants be able to access the findings from the study they were involved with?
• How will participants be able to access the findings from the study after it is completed?
Post-trial access (if applicable):
• Will participants be able to continue using any intervention they received during the study after it is completed?
Payment and/or reimbursement:
• Will participants receive any payment or reimbursement for their participation?
• How and when will participants receive payment/reimbursement?
• How much payment/reimbursement will participants receive?
Study related injury or difficulties:
• How and when will study related difficulties be reported?
• Will study related difficulties be reported to chief investigator/sponsor?
• Will study related difficulties be documented in the final report/dissemination?
Other ethical concerns:
• What other ethical issues need to be considered?
