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Trial registered on ANZCTR


Registration number
ACTRN12617001549314
Ethics application status
Approved
Date submitted
18/10/2017
Date registered
10/11/2017
Date last updated
10/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial (RCT) of AdaptHIV, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in men who have sex with men (MSM) who are living with HIV.
Scientific title
A Randomised Controlled Trial (RCT) of AdaptHIV, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in men who have sex with men (MSM) who are living with HIV.
Secondary ID [1] 293156 0
nil known
Universal Trial Number (UTN)
Trial acronym
AdaptHIV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 305132 0
depression 305133 0
HIV 305134 0
Condition category
Condition code
Mental Health 304454 304454 0 0
Anxiety
Mental Health 304455 304455 0 0
Depression
Infection 304456 304456 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTRODUCTION
The Clinical Research Unit for Anxiety and Depression (CRUfAD) have developed an online cognitive behavioural therapy (CBT) intervention for anxiety and depression for men who are living with HIV. It is called iAdapt. Aspects of existing online interventions for anxiety and depression were adapted to the HIV context in the development of the iAdapt program. iAdapt is a 12 week self-managed, mixed anxiety and depression program that is tailored to unique aspects of the HIV context and LGBTI experience.

PROPOSAL
The proposed study will evaluate the efficacy of the newly developed program as a HIV specific, online intervention for anxiety and depression and will aim to demonstrate that iCBT is an effective program for reducing anxiety and depressive symptoms fro men who are living with HIV.

ALLOCATION
Participants with elevated anxiety and depression scores and a diagnosis (>6 months) of HIV will be recruited. They will complete online screening questionnaires on CRUfAD's clinical trials website (www.virtualclinic.org.au) to assess eligibility to participate, and provide informed consent. If accepted into the study, the participant will be randomly allocated into one of two groups:
GROUP 1 receive access to the iAdapt program
GROUP 2 treatment as usual group (may access care at any point) and after a 12 week period, will then be offered access the iAdapt program.

OVERVIEW OF PROGRAM
The iAdapt program consists of six ‘Modules’ based on cognitive behavioural therapy (CBT). It includes all treatment components typically seen in face-to-face CBT (the first-line treatment for depression and anxiety for people who are living with HIV). Each of the six ‘Modules’ can be considered as a discrete package. Each of the ‘Modules’ contains:
- A Lesson (consists of a comic based, easy to read story, pertinent to all participants),
- An associated Lesson Summary (consists of more dense reading material, likely pertinent to all participants)
- Any additional resources for that part (which may not be needed by all participants)
- Any additional worksheets for that part (pertinent to all participants)

THEMES of THE MODULES
The overriding messages in each ‘Module’ i.e. the each ‘Lesson’ and it’s associated ‘Lesson Summary’, and any additional resources is arranged by themes. The main themes are:
Module/Lesson 1 Learning about Depression and Anxiety in HIV
Module /Lesson 2 Identifying and Tackling Thoughts
Module/Lesson 3 Tackling Unhelpful Behaviours
Module/Lesson 4 Tackling Avoidance
Module/Lesson 5 Helpful Coping
Module/Lesson 6 Mastering your skills

EXAMPLE of a MODULE
Hence, for ‘Module 3’ the theme is “Tackling Unhelpful Behaviours”, hence the Lesson shows the characters addressing their unhelpful behaviours in a comic based, easy to follow story. Further specific, more detailed, writing is contained in the Lesson summary, in this case under the following headings:
1. Tackling Low Activity
2. Before starting activity scheduling and physical activity
3. Daily Activity Scheduling
4. Physical Activity
5. Structured Problem Solving
6. Your Action Plan
7. Summary

In this case, the Extra Resources in ‘Module 3’ are:
Furthermore, worksheets relevant to the Lesson/ Lesson Summary are provided:
Activity planning and Monitoring worksheet
Structured Problem Solving worksheet
Pros and Cons Worksheet

HOW TO WORK THROUGH THE PROGRAM
Participants will asked to complete the Lesson (including the questionnaires beforehand for that lesson). Each lesson will take approximately 45 - 60 minutes to complete. They may go through all slides in a single sitting, or they may take multiple sittings to get to the end. Once they have completed the Lesson, the computer system automatically releases the associated Lesson Summary (i.e. it becomes available for download on completion of the lesson). They participant are asked to practice any associated skills/activities over the course of the following 14 days. Furthermore, upon completion of the Lesson, the extra resources for that part of the course, that ‘Module’, similarly become available. We ask participants to aim for an additional 3 hours per week to read these associated resources and to put into practice the CBT skills.

TIMING of EACH MODULE
There is a purposeful lock-out time of 5 days between release of the subsequent ‘Module’ i.e. next Lesson & Lesson Summary etc. The 5-day lock-out refers to specific time points for the release of the next lesson and its associated lesson summary. For example, if a participant undertook Lesson 4 in one sitting & hence downloaded the Lesson 4 Summary on 01st of the month, we purposely do not allow them to start ‘Module 5’, i.e. Lesson 5, until at least 5 days later, the 05th of the month. We will recommend instead that they spend up to two weeks (until the 14th of the month) reflecting and working through the prior Module i.e. Lesson 4, Lesson 4 Summary/ recommendations. However, as some patients prefer to progress at a quicker pace we do not necessitate the full 14 day period. Instead a five day minimum is set; to ensure that the patient does not get information overload and to encourage them to reflect and undertake activities for at least a short time period.

CONTACT
Routine email contact from the clinician (registered clinical psychologist or psychiatry trainee/ medical officer) after completion of the first two lessons will occur. Further email contact will occur then as required. The participant is also able to email or phone the clinician at any point during the trial as required. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations the clinician is automatically alerted and initiates contact with the participant by phone or email.

ADHERENCE
Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 299405 0
Treatment: Other
Intervention code [2] 299406 0
Behaviour
Comparator / control treatment
Control GROUP - treatment as usual group (may access care at any point) and after a 16 week period, will then be offered access the iAdapt program.

These participants will complete 3 sets of questionnaires during their waiting period. Once the immediate treatment group has completed the iAdapt online program and post-treatment questionnaires, the control group will be offered the same program.

Should participants wish may access standard care for depression/anxiety through their usual healthcare pathway. In the case of these participants we foresee that they may attend local mental health practitioners/ GP, or psycho-social support staff at their local cancer centre during this time period. Should they choose to do so, we ask them to let us know. They are not excluded from the trial if they choose to access assistance.
Control group
Active

Outcomes
Primary outcome [1] 303698 0
Changes in the anxiety scores according the GAD -7
Timepoint [1] 303698 0
Baseline
Midpoint - program lesson 4
One week post treatment - primary timepoint change from BL
3 months post treatment
Primary outcome [2] 303779 0
Changes in depression scores according to the PHQ-9
Timepoint [2] 303779 0
Baseline
Midpoint - program lesson 4
One week post treatment - primary timepoint change from BL
3 months post treatment
Secondary outcome [1] 339891 0
Changes in severity of psychological distress according to mean scores on the Kessler-10 (k10)
Timepoint [1] 339891 0
Baseline
Prior to each lesson
One week post treatment
3 months post treatment
Secondary outcome [2] 339892 0
Changes in the physical, social and emotional and functional status as measured by the Functional Assessment of HIV infection (FAHI, composite score)
Timepoint [2] 339892 0
Baseline
One week post treatment
3 month follow up
Secondary outcome [3] 339893 0
Changes in suicidal ideation and/or passive death wish as measured by PHQ-9 question 9 and BDI-II, item 9 (single item score)
Timepoint [3] 339893 0
baseline
midpoint - program lesson 4
post treatment
3 months post treatment
Secondary outcome [4] 339894 0
The feasibility of the treatment in terms of acceptability to patients and practicality for clinicians (as measured by changes in the Credibility/Expectancy Questionnaire; CEQ) - composite measure
Timepoint [4] 339894 0
Baseline
Midpoint - program lesson 4
One week post-treatment
3 months post treatment
Secondary outcome [5] 339897 0
c-ART adherence as measured by single item question.
Timepoint [5] 339897 0
Baseline antiretroviral medication adherence (note antiretrovirals are not the intervention in this trial)
Prior to each lesson - all timepoints
one week post treatment
3 months post treatment

Eligibility
Key inclusion criteria
Males, aged over 18 years old with no maximum age, self-identified as suffering from depression and/or anxiety and have online questionnaire scores indicating a clinical level of anxiety and/or depression on GAD-7, and/or the PHQ-9.
Presence of HIV (>6 months since diagnosis) will be based on self-report. Participants must be prepared to provide name/location of their HIV specific service.
Prepared to provide own name, phone number and address.
Prepared to provide the name and address of a local general practitioner
English language skills equivalent to a School Certificate level.
Have access to a phone and a computer with internet and a printer.
Willingness to give written informed consent and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Mental health exclusion criteria will include psychosis, bipolar disorder, substance dependence and severe depression (PHQ-9 >23), or current suicidality (PHQ-9, Item 9 = 3; or BDI-II, Item 9 = 2 or 3). People excluded because of severe depression or suicidality at online application will be advised as to an appropriate course of action and appropriate treatment options on-screen and in writing via email
HIV related exclusion criteria will include:
• HIV related cognitive impairment
• Currently in-patient.
• Being within the first 6 months of HIV diagnosis.
• Concurrent brain cancer/ malignancy.
If currently taking an antidepressant, participants will also be excluded if they have had a dose or medication change in prior 8 weeks.



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)
Patients who meet inclusion criteria for the study will be randomly allocated to one of the two groups (Group 1 iCBT; Group 2 deferred iCBT).
Allocation concealment will occur in the following way: participants will be randomly allocated to each group via the virtualclinic software, without staff member involvement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation generated via software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Deferred treatment
All participants will be given access to the treatment program
Group 1 will receive prompt access
Group 2 will wait until the first group have completed the program, and at the 12 week point
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
SAMPLE SIZE CALCULATION
We would expect pre-post improvement of Effect Size (ES) 1.0 for the iCBT group on the primary outcome measures. We also expect the iCBT group to improve more than the waitlist group by an ES of 0.6. Sample size is powered to have an 80% chance of detecting differences at p<.05.

ANALYSIS PLAN
All analyses will be undertaken using liner mixed models. Relationships between observations at different occasions will be modelled with an unstructured covariance matrix. For each experimental group, planned contrasts will be used to compare changes between pre- treatment and post-treatment, and at 3-month follow-up for the iCBT group only. Planned pairwise comparisons will be used to compare between-groups at post-treatment, and effect sizes will be calculated (Cohen’s d) to measure the size of the between-groups difference on primary and secondary outcome measures.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
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
Recruitment hospital [1] 9202 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 17855 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 297783 0
Hospital
Name [1] 297783 0
St Vincent's Hospital
Address [1] 297783 0
390 Victoria Street
Darlinghurst NSW 2010
Country [1] 297783 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 296819 0
None
Name [1] 296819 0
Address [1] 296819 0
Country [1] 296819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298841 0
St Vincent's Hospital HREC
Ethics committee address [1] 298841 0
St. Vincent's Hospital Research Office
Level 6, de Lacy Building
390 Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 298841 0
Australia
Date submitted for ethics approval [1] 298841 0
09/03/2017
Approval date [1] 298841 0
12/05/2017
Ethics approval number [1] 298841 0
HREC/17/SVH/74

Summary
Brief summary
The primary purpose of this trial is to evaluate the efficacy of an internet program, iAdapt for depression and anxiety in men who are living with HIV.

Who is it for?
You may be eligible to participate in this study if you are aged 18 or over, suffer from anxiety or depression and have a diagnosis of HIV.

Study details
All participants enrolled in this study will be randomly allocated (by chance) to receive the iAdapt program soon after enrolment or 12 weeks later. The iAdapt program is a 12 week online program which involves learning about tackling depression with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 6 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1 – 2 weeks. There will also then be additional activities to do for around 3 hours per week.
Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson.

It is hoped that the findings of this trial will provide information regarding the efficacy of the iAdapt program in reducing depression and anxiety for men who are living with HIV
Trial website
www.virtualclinic.org.au
www.adapthiv.org.au
Trial related presentations / publications
Nil as yet
Public notes

Contacts
Principal investigator
Name 78410 0
Prof Gavin Andrews
Address 78410 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 78410 0
Australia
Phone 78410 0
+61283821400
Fax 78410 0
+61283821401
Email 78410 0
gavina@unsw.edu.au
Contact person for public queries
Name 78411 0
Dr Michael Millard
Address 78411 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 78411 0
Australia
Phone 78411 0
+61283821400
Fax 78411 0
+61283821401
Email 78411 0
michael.millard@svha.org.au
Contact person for scientific queries
Name 78412 0
Dr Michael Millard
Address 78412 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 78412 0
Australia
Phone 78412 0
+61283821400
Fax 78412 0
+61283821401
Email 78412 0
michael.millard@svha.org.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary