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Trial registered on ANZCTR


Registration number
ACTRN12624000453583
Ethics application status
Approved
Date submitted
15/03/2024
Date registered
12/04/2024
Date last updated
29/07/2024
Date data sharing statement initially provided
12/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote Cognitive Behavioural Therapy (CBT) for Anxiety Disorders in Lesbian, Gay, Bisexual, Transgender, Queer, Questioning, and Non-Heterosexual or Non-Cisgender (LGBTQ+) People
Scientific title
Efficacy of Remote Cognitive Behavioural Therapy to Reduce Anxiety Disorder Severity in LGBTQ+ People: An Exploratory Trial Protocol
Secondary ID [1] 311721 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 333198 0
Condition category
Condition code
Mental Health 329888 329888 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The immediate treatment group will receive treatment consisting of 50-minute weekly appointments, delivered over eight weeks. This treatment is based on the manual for the Unified Protocol (Barlow et al., 2018), and each of the eight modules will be delivered over videoconferencing in eight one-on-one sessions. The typical eight-module treatment will cover: psychoeducation on the CBT model and goals; mindfulness of emotions; building cognitive flexibility with restructuring; addressing emotional avoidance and emotion-driven behaviours; behavioural exposures/experiments; and relapse prevention.

Clients will be assigned therapeutic activities to complete in between sessions, as per standard practice in previous trials (Pachankis et al., 2015; Pachankis et al., 2020; Pachankis et al., 2023). Between-session therapeutic tasks may involve completing thought monitoring forms, doing mindfulness exercises, completing behavioural experiments or exposures, and so on. Each activity is typically short, taking approximately 5 - 30 minutes, and will differ from week to week. The time expected to be spent on these activities will depend on client goals and presenting problems and is unlikely to exceed three hours per week.

The treatment provided in the trial will be delivered by generally registered psychologists or provisionally registered psychologists. All clinicians will provide treatment while under the supervision of a clinical psychologist experienced in delivering treatments for anxiety and related disorders. The project investigators will provide training in delivery of the treatment protocol, and all clinicians will receive regular clinical supervision. To monitor treatment fidelity, at least 10% of session recordings will be randomly selected for review by a study investigator.

Additionally, eight to ten participants will be invited to participate in a qualitative interview to evaluate intervention acceptability from both the immediate intervention group and control group (after commencing treatment), with a total of 16 – 20 participants. This sample size is consistent with previous studies in this area of research (Jackson et al., 2022; Pachankis et al., 2020). Participants will be selected based on a representative matrix that aims to achieve a maximally diverse sample, as per previous studies (Christensen et al., 2023). Participants will be interviewed by a member of the research team who did not provide the treatment wherever possible. To encourage candid feedback, the benefits of honest feedback from participants for improving the intervention will be discussed early on during the interview. To encourage candid feedback, the benefits of honest feedback from participants for improving the intervention will be discussed early on during the interview. The interview will be audio recorded to assist with transcription and is expected to take approximately 30 to 60 minutes.
Intervention code [1] 328185 0
Behaviour
Comparator / control treatment
After an eight-week waitlist period, the control group will also receive eight weekly 50-minute sessions delivered one-on-one via video-conferencing. This treatment is based on the LGBTQ-Affirmative adapted version of the Unified Protocol (Pachankis et al., 2022). The intervention will still consist of the essential elements of the immediate intervention group’s treatment but includes adaptions based on previously conducted qualitative interviews with LGBTQ+ stakeholders and therapists with experience working in the LGBTQ+ community (Pachankis et al., 2015).

The adaptations centralise minority stress in treatment by considering it as a key maintaining factor in the client’s presenting problems and anxiety disorder symptoms (Hatzenbuehler, 2009; Meyer, 2003). It does this by prioritising the installation of skills to cope with minority stress, such as assertiveness and minority stress-informed psychoeducation. The adaptation also targets minority stress-based thoughts and core beliefs. For each skill provided in the original UP, the LGBTQ-adapted UP provides examples and/or case vignettes that are minority stress-based to emphasize that the skills learned in cognitive behavior therapy can be applied and used to deal with minority stress. For example, one vignette in the cognitive flexibility module asks participants to identify their automatic interpretations of an ambiguous mock text exchange in which an LGBTQ+ person makes a last-minute request to bring their new partner to an open-invite event but has no response from their friends.

The treatment will cover psychoeducation on the CBT model and goals; understanding the nature and emotional impact of LGBTQ-related stress; mindfulness of emotions; building cognitive flexibility with restructuring; addressing emotional behaviours; behavioural exposures/experiments; and relapse prevention. As in standard CBT practice and in the immediate intervention group, participants will be asked to complete therapy-related tasks between sessions.

The treatment provided in the trial will be delivered by generally registered psychologists or provisionally registered psychologists. All clinicians will provide treatment while under the supervision of a clinical psychologist experienced in delivering treatments for anxiety and related disorders. The project investigators will provide training in delivery of the treatment protocol, and all clinicians will receive regular clinical supervision. To monitor treatment fidelity, at least 10% of session recordings will be randomly selected for review by a study investigator.
Control group
Active

Outcomes
Primary outcome [1] 337655 0
Anxiety disorder severity and associated impairment
Timepoint [1] 337655 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9, primary endpoint), and 3-month follow-up after treatment completion.
Secondary outcome [1] 432706 0
Depressive disorder severity and associated impairment
Timepoint [1] 432706 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [2] 432707 0
Generalised anxiety symptom severity
Timepoint [2] 432707 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9) , and 3-month follow-up after treatment completion.
Secondary outcome [3] 432708 0
Social anxiety symptom severity
Timepoint [3] 432708 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [4] 432709 0
Panic symptom severity
Timepoint [4] 432709 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [5] 432710 0
Agoraphobia symptom severity
Timepoint [5] 432710 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [6] 432711 0
Specific phobia symptom severity
Timepoint [6] 432711 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [7] 432712 0
Separation anxiety symptom severity
Timepoint [7] 432712 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [8] 432713 0
Severity of depressive symptoms
Timepoint [8] 432713 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [9] 432714 0
Interpersonal stigma directed toward one’s sexual orientation or gender identity
Timepoint [9] 432714 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [10] 432715 0
Internalised homophobia severity
Timepoint [10] 432715 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [11] 432716 0
Sexual orientation concealment
Timepoint [11] 432716 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [12] 432717 0
Rejection sensitivity
Timepoint [12] 432717 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [13] 432718 0
Participant self-rated and clinician-assessed global change in anxiety disorder symptom severity.
Timepoint [13] 432718 0
Mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [14] 432719 0
Participant self-rated and clinician-assessed Anxiety disorder symptom severity
Timepoint [14] 432719 0
Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [15] 432721 0
Treatment satisfaction
Timepoint [15] 432721 0
Mid-treatment (week 4) and post-treatment (week 9).
Secondary outcome [16] 432722 0
Treatment acceptability
Timepoint [16] 432722 0
Mid-treatment (week 4) and post-treatment (week 9).
Secondary outcome [17] 432729 0
Therapeutic alliance
Timepoint [17] 432729 0
Mid-treatment (week 4) and post-treatment (week 9).
Secondary outcome [18] 432730 0
Health professionals seen and treatments used by participants due to their anxiety and / or depression symptoms
Timepoint [18] 432730 0
Post-treatment (week 9), and 3-month follow-up after treatment completion.
Secondary outcome [19] 432731 0
Client daily treatment adherence
Timepoint [19] 432731 0
Mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Eligibility
Key inclusion criteria
The randomised control trial and qualitative semi-structured interviews will utilise the following inclusion criteria:
(1) Presently residing in Australia;
(2) Aged 18 years or over;
(3) Fluent in English;
(4) Meets criteria for an anxiety disorder as either the primary diagnosis (or co-primary with a depressive disorder) and the disorder is of at least ‘moderate severity’ (defined as a score of 4 on the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders [DIAMOND] module severity measure);
(5) Medication-free or on a stable dose (8 weeks) of psychotropic medication; and
(6) Not presently receiving regular psychological services for their anxiety symptoms (defined as sessions at least once a week with a qualified mental health professional);
(7) Identify as LGBTQ+; and
(8) Have access to a private location to complete the treatment for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Suicide risk as assessed by item 9 of the PHQ-9 (a score of 2 or above) at baseline, the Columbia Suicide Severity Rating Scale, or via clinician judgement during the diagnostic interview.
(2) Engagement in non-suicidal self-injury in the past 12 months;
(2) Daily use of alcohol or illicit drugs (meaning illegal drugs, pharmaceutical drugs used outside of their prescribed or intended use, and other substances inappropriately used);
(3) The presence of a schizophrenia spectrum disorder as assessed by the DIAMOND semi-structured clinical interview;
(4) Any significant cognitive/intellectual impairment as assessed during the diagnostic interview;
(5) A medical condition that may interfere with treatment;
(6) No access to a computer with a camera and stable internet on a regular basis;
(7) Is not willing to engage in treatment on a regular basis using internet-videoconferencing software;
(8) Does not explicitly identify as LGBTQ+;and
(9) Does not indicate any anxiety disorder symptoms on the DIAMOND Self Report screener.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In this study, allocation will not be concealed, due to the nature of psychology treatment. Randomisation occurs after assessment and randomisation will be conducted by the Chief Investigator using a random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a random number generator via the website www.random.org to ensure unbiased selection. Assessing clinicians will not be aware of the randomisation status of participants and will be advised of their participants’ group randomisation by the Principal Investigator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2024
Actual
18/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316051 0
University
Name [1] 316051 0
University of Technology Sydney
Country [1] 316051 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 318211 0
None
Name [1] 318211 0
Address [1] 318211 0
Country [1] 318211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314871 0
UTS Health and Medical Research Ethics Committee
Ethics committee address [1] 314871 0
Ethics committee country [1] 314871 0
Australia
Date submitted for ethics approval [1] 314871 0
13/11/2023
Approval date [1] 314871 0
28/05/2024
Ethics approval number [1] 314871 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133002 0
A/Prof Bethany Wootton
Address 133002 0
Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney. PO Box 123, Broadway, NSW 2007.
Country 133002 0
Australia
Phone 133002 0
+61 2 9514 3942
Fax 133002 0
Email 133002 0
Bethany.Wootton@uts.edu.au
Contact person for public queries
Name 133003 0
A/Prof Bethany Wootton
Address 133003 0
Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney. PO Box 123, Broadway, NSW 2007.
Country 133003 0
Australia
Phone 133003 0
+61 2 9514 3942
Fax 133003 0
Email 133003 0
Bethany.Wootton@uts.edu.au
Contact person for scientific queries
Name 133004 0
Bethany Wootton
Address 133004 0
Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney. PO Box 123, Broadway, NSW 2007.
Country 133004 0
Australia
Phone 133004 0
+61 2 9514 3942
Fax 133004 0
Email 133004 0
Bethany.Wootton@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only non-identifiable, primary and secondary outcome measure data will be made available. Selected demographic details may be shared, but only to the extent that participants cannot be identified.
When will data be available (start and end dates)?
Data will be available immediately following publication and will be available for five years from the completion of the study.
Available to whom?
Data will be made available to suitably qualified academic researchers in the area of anxiety disorders, LGBTQ+ mental health, cognitive behavioural therapy, or remote adaptions of therapy.
Available for what types of analyses?
Any analysis that is compliant with the terms participants agreed to in their Participant Information and Consent form, such as de-identification, Australian / New South Wales privacy laws, and general ethical principles in The National Statement.
How or where can data be obtained?
The following documents will be uploaded to the Australian and New Zealand Clinical Trials Registry upon ethics approval or can be obtained by emailing the Principal Investigator bethany.wooton@uts.edu.au:
• Participant Information and Consent Form
• Ethics approval documents
• The study protocol


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21861Study protocol    387486-(Uploaded-29-05-2024-10-46-47)-Protocol_V2.2.docx
21862Informed consent form    387486-(Uploaded-29-05-2024-10-46-47)-PICF V2.3.docx
21863Ethical approval    387486-(Uploaded-28-07-2024-23-39-14)-UTS HREC Approval - ETH24-9458.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.