ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

22/10/2021

Date data sharing statement initially provided

13/11/2019

Date results provided

22/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Group Transdiagnostic Treatment for Anxiety and Depression in Primary Care delivered via Zoom

Scientific title

Open label Group Transdiagnostic Cognitive Behavioural Therapy for Anxiety and Depression in Primary Care delivered via Zoom

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1235-5047

Trial acronym

Linked study record

Health condition

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

anxiety

depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A Zoom assessment then 4x 2 hour weekly sessions of Zoom 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]

Treatment: Other

Comparator / control treatment

There is no longer a control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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 [1]

1 month (therapy completion)

Primary outcome [2]

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 [2]

Acceptability of treatment and study protocol measured by: If fewer than 75% participants complete psychological measures at the 3 time points (baseline, 3,6 months), the study protocol will be deemed unacceptable to participants. 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.

Secondary outcome [1]

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]

3 and 6 months post baseline assessment

Secondary outcome [2]

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]

Immediately following the 1 day training session.

Secondary outcome [3]

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]

Baseline and 3,6 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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

17/02/2020

Actual

17/02/2020

Date of last participant enrolment

Anticipated

1/06/2020

Actual

23/11/2020

Date of last data collection

Anticipated

30/06/2021

Actual

18/05/2021

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

PO Box 5541, Wellesley Street, Auckland 1141

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

19/08/2019

Approval date [1]

23/09/2019

Ethics approval number [1]

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 for adults with anxiety and/or depression who are referred by brief intervention workers for zoom Transdiagnostic Cognitive Behavioural Therapy in Christchurch. The study will evaluate the feasibility of studying group transdiagnostic treatment (involving up to 10 participants over four, 2-hour sessions).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ben Beaglehole

Address

Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140

Country

New Zealand

Phone

+64 027 212 7488

Fax

ben.beaglehole@otago.ac.nz

Contact person for public queries

Name

Ben Beaglehole

Address

Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140

Country

New Zealand

Phone

+64 027 212 7488

Fax

ben.beaglehole@otago.ac.nz

Contact person for scientific queries

Name

Ben Beaglehole

Address

Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140

Country

New Zealand

Phone

+64 027 212 7488

Fax

ben.beaglehole@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data will only be specific to this study

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Feasibility study of brief Group Transdiagnostic Cognitive Behavioural Treatment delivered via Zoom for anxiety and depression in primary care.	2023

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically