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Trial registered on ANZCTR


Registration number
ACTRN12619001563156
Ethics application status
Approved
Date submitted
25/10/2019
Date registered
13/11/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Transdiagnostic Treatment for Anxiety and Depression in Primary Care.
Scientific title
Randomised controlled trial of group transdiagnostic treatment for anxiety and depression in primary care
Secondary ID [1] 298513 0
Nil known
Universal Trial Number (UTN)
U1111-1235-5047
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 313314 0
depression 313315 0
Condition category
Condition code
Mental Health 311754 311754 0 0
Anxiety
Mental Health 311755 311755 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An assessment then 4x 2 hour weekly sessions of face to face group transdiagnostic cognitive behavioural therapy (Group TCBT) for anxiety and depression. Maximum of 10 participants/group.

Group TCBT will be facilitated by an experienced psychologist familiar with Group TCBT in various forms and co-facilitated by a community therapist (nurse/Occupational Therapist/Social Worker/ or Psychologist) familiar with individual brief intervention counselling (the usual intervention for patients with anxiety and depression in the community).

The Group TCBT will follow a manual developed specifically for this group by the experienced psychologists. The community therapist will participate in a 1 day training programme prior to group commencement.

Content of the group will cover the following content: Socialisation to the group, goal setting and motivation, introduction to the TCBT model, understanding the function of emotion, emotion-driven behaviours and the role of avoidance, behavioural activation, learning to observe emotions and thoughts (mindfulness exercises). Thinking biases and thought restructuring, behavioural experiments, awareness of and tolerating physiological sensations (including interoceptive exposures), and relapse prevention. A treatment integrity checklist will be used to ensure all planned content is covered during each group programme.

Attendance at groups will be monitored. Assessments for the groups will occur in the month prior to group commencement.
Intervention code [1] 314763 0
Treatment: Other
Comparator / control treatment
Up to five sessions of usual care (individual psychological treatment for anxiety and depression). Typically sessions are scheduled weekly. The initial session includes assessment and is approximately 45 minutes duration with follow up sessions being 30-40 minutes duration.

The active and controlled treatments are not designed to be equivalent in patient contact time. The primary outcomes are related to study feasibility. In addition, there are efficiency gains in the provision of group treatment meaning duration of treatment can be longer than than provided in the usual care setting and still provide potential service benefits if subsequent studies suggest benefits of Group TCBT for patients.
Control group
Active

Outcomes
Primary outcome [1] 320438 0
feasibility of engagement measured by:

If fewer than 50% of patients approached agree to participate, this will be deemed unfeasible.

Group TCBT co-facilitators will ring all patients identified as potential participants through the triage process. The number of patients identified will be tracked and recorded in an Excel spreadsheet or similar. Actual numbers of patients who agree to participate following phone contact and face to face meeting will also be recorded and the percentage of patients who agree to participate calculated.
Timepoint [1] 320438 0
baseline
Primary outcome [2] 320506 0
Feasibility of study intervention measured by:

If greater than 50% of patients fail to complete at least 3/4 group treatment sessions, we will deem the trial unfeasible. Group attendance will tracked by taking a role and recorded for each group.
Timepoint [2] 320506 0
1 month (therapy completion)
Primary outcome [3] 320507 0
Acceptability of treatment and study protocol measured by:

If fewer than 75% participants complete psychological measures at the 4 time points (baseline, 3,6, and 12 months) in both groups, the study will be deemed unfeasible.

Outcome measures are the PHQ-9 and GAD-7. These will be completed face to face at the assessment and then through telephone contact with the research assistant for subsequent time points.
Timepoint [3] 320507 0
12 months following baseline assessment.
Secondary outcome [1] 371599 0
Reliable recovery. The definition of reliable recovery is taken from the Improved Access to Psychological Therapy (IAPT) study in the UK.

Reliable recovery is measured by scoring above clinical cut-off for PHQ-9 and GAD-7 at baseline assessment, scoring below clinical cut-off for PHQ-( and GAD-& at the end of treatment, and showed reliable improvement over treatment (pre-post change in PHQ-9>5,3 and GAD-7>3,53) (these are minimal change criteria and not results per se).
Timepoint [1] 371599 0
3, 6, and 12 months post baseline assessment
Secondary outcome [2] 371600 0
This is a composite measure measuring the acceptability and effectiveness of training group trans-diagnostic facilitators. This will be assessed by a brief qualitative survey still to be designed specifically for the study.
Timepoint [2] 371600 0
Immediately following the 1 day training session.
Secondary outcome [3] 371841 0
Acceptability of study intervention and design for Maori participants measured by sub-group analysis of recruitment, treatment completion, drop-out rates, and satisfaction ratings.
Timepoint [3] 371841 0
Baseline and 3,6,12 months

Eligibility
Key inclusion criteria
All patients referred for psychological assistance with anxiety and depression by GPs to brief intervention services and deemed appropriate for psychological intervention by brief intervention services will be eligible for study entry.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not eligible include those whom alcohol and drugs are identified as the main clinical issue, those for whom a referral to specialty services is appropriate to manage moderate-severe illness or high levels of risk, and those with significant cognitive problems that mean psychological interventions are not possible unless in modified form.

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)
Computer generated randomisation held centrally
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a feasibility study. No power calculation is required.
Study feasibility will be measured using descriptive statistics (percentage approached who participate, percentage completing treatment, percentage completing follow up measures, and percentage achieving reliable recovery).

Reliable recovery rates and completion rates will be compared between groups using comparative statistics (repeated measures ANOVA).

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 21630 0
New Zealand
State/province [1] 21630 0
Canterbury

Funding & Sponsors
Funding source category [1] 303059 0
Government body
Name [1] 303059 0
Health Research Council of New Zealand
Address [1] 303059 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 303059 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ben Beaglehole
Address
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 303041 0
None
Name [1] 303041 0
Address [1] 303041 0
Country [1] 303041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303609 0
Health and Disability Ethics Committee
Ethics committee address [1] 303609 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 303609 0
New Zealand
Date submitted for ethics approval [1] 303609 0
19/08/2019
Approval date [1] 303609 0
23/09/2019
Ethics approval number [1] 303609 0
19/NTB/143

Summary
Brief summary
Anxiety and depression are the most common mental health presentations in primary
Care. Usual treatment for anxiety and depression consists of antidepressants and psychological interventions. The most common psychological intervention is individual Cognitive Behavioural Therapy-informed sessions by brief intervention counsellors.

This may not be the most effective or efficient model of treatment. Transdiagnostic (targeting depression and a range of anxiety disorders) treatment in group form provides an efficient way to deliver effective treatment that targets the common factors and processes underlying anxiety and depressive symptoms.

We believe that group transdiagnostic treatment will allow for treatment of more people
with the same clinician resource and be more effective than treatment currently offered.

This trial is of 80 adults with anxiety and/or depression referred to brief intervention
services for psychological intervention in Christchurch. The study will evaluate the feasibility of studying group transdiagnostic treatment (involving 10 participants over four, 2-hour sessions) compared with usual treatment (which is up to four 1-hour sessions of individual treatment by brief intervention clinicians).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94246 0
Dr Ben Beaglehole
Address 94246 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country 94246 0
New Zealand
Phone 94246 0
+64 027 212 7488
Fax 94246 0
Email 94246 0
ben.beaglehole@otago.ac.nz
Contact person for public queries
Name 94247 0
Dr Ben Beaglehole
Address 94247 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country 94247 0
New Zealand
Phone 94247 0
+64 027 212 7488
Fax 94247 0
Email 94247 0
ben.beaglehole@otago.ac.nz
Contact person for scientific queries
Name 94248 0
Dr Ben Beaglehole
Address 94248 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country 94248 0
New Zealand
Phone 94248 0
+64 027 212 7488
Fax 94248 0
Email 94248 0
ben.beaglehole@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will only be specific to this study
What supporting documents are/will be available?
No other documents available
Summary results
No Results