None listed
Conditions
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
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.