ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety Disorders

Condition category

Condition code

Mental Health

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]

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]

Anxiety disorder severity and associated impairment

Timepoint [1]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9, primary endpoint), and 3-month follow-up after treatment completion.

Secondary outcome [1]

Depressive disorder severity and associated impairment

Timepoint [1]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [2]

Generalised anxiety symptom severity

Timepoint [2]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9) , and 3-month follow-up after treatment completion.

Secondary outcome [3]

Social anxiety symptom severity

Timepoint [3]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [4]

Panic symptom severity

Timepoint [4]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [5]

Agoraphobia symptom severity

Timepoint [5]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [6]

Specific phobia symptom severity

Timepoint [6]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [7]

Separation anxiety symptom severity

Timepoint [7]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [8]

Severity of depressive symptoms

Timepoint [8]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [9]

Interpersonal stigma directed toward one’s sexual orientation or gender identity

Timepoint [9]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [10]

Internalised homophobia severity

Timepoint [10]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [11]

Sexual orientation concealment

Timepoint [11]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [12]

Rejection sensitivity

Timepoint [12]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [13]

Participant self-rated and clinician-assessed global change in anxiety disorder symptom severity.

Timepoint [13]

Mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [14]

Participant self-rated and clinician-assessed Anxiety disorder symptom severity

Timepoint [14]

Pre-treatment, mid-treatment (week 4), post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [15]

Treatment satisfaction

Timepoint [15]

Mid-treatment (week 4) and post-treatment (week 9).

Secondary outcome [16]

Treatment acceptability

Timepoint [16]

Mid-treatment (week 4) and post-treatment (week 9).

Secondary outcome [17]

Therapeutic alliance

Timepoint [17]

Mid-treatment (week 4) and post-treatment (week 9).

Secondary outcome [18]

Health professionals seen and treatments used by participants due to their anxiety and / or depression symptoms

Timepoint [18]

Post-treatment (week 9), and 3-month follow-up after treatment completion.

Secondary outcome [19]

Client daily treatment adherence

Timepoint [19]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Technology Sydney

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Technology Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UTS Health and Medical Research Ethics Committee

Ethics committee address [1]

https://www.uts.edu.au/research-and-teaching/research/our-approach/ethics-and-integrity/human-research-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/11/2023

Approval date [1]

28/05/2024

Ethics approval number [1]

Summary

Brief summary

The purpose of this study is to examine the efficacy, feasibility, and acceptability of videoconferencing-delivered CBT for anxiety disorders in LGBTQ+ adults. A CONSORT-R compliant, two-group, randomised control feasibility trial (RCT) will examine the research questions. The hypotheses for this study are below: 
1)	Videoconferencing-delivered, standard CBT will result in significant reductions in symptoms with a large between-group and within-group effect size at post-treatment and three-month follow-up. 
2)	Videoconferencing-delivered, LGBTQ-adapted CBT will result in a similar degree of symptom reduction when compared to standard CBT. 
3)	Videoconferencing-delivered standard CBT and LGBTQ-adapted CBT will be feasible to deliver to LGBTQ+ adults with diagnosed anxiety 
4)	Videoconferencing-delivered CBT will be acceptable to LGBTQ+ adults with diagnosed anxiety disorders

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Bethany Wootton

Address

Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney. PO Box 123, Broadway, NSW 2007.

Country

Australia

Phone

+61 2 9514 3942

Fax

[email protected]

Contact person for public queries

Name

A/Prof Bethany Wootton

Address

Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney. PO Box 123, Broadway, NSW 2007.

Country

Australia

Phone

+61 2 9514 3942

Fax

[email protected]

Contact person for scientific queries

Name

Bethany Wootton

Address

Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney. PO Box 123, Broadway, NSW 2007.

Country

Australia

Phone

+61 2 9514 3942

Fax

[email protected]

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 [email protected]:
• Participant Information and Consent Form
• Ethics approval documents
• The study protocol

What supporting documents are/will be available?

Doc. No.	Type	Attachment
21861	Study protocol	387486-(Uploaded-29-05-2024-10-46-47)-Protocol_V2.2.docx
21862	Informed consent form	387486-(Uploaded-29-05-2024-10-46-47)-PICF V2.3.docx
21863	Ethical 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.

Trial Review

Documents added manually

Documents added automatically