Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000250437
Ethics application status
Approved
Date submitted
17/02/2016
Date registered
23/02/2016
Date last updated
23/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Community-based group cognitive behaviour therapy for adults with anxiety disorders
Scientific title
Community-based group cognitive behaviour therapy for adults with anxiety disorders in primary care settings: a pilot study
Secondary ID [1] 288560 0
Nil known
Universal Trial Number (UTN)
U1111-1176-8026
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any anxiety disorder (with or without depressive symptoms) 297682 0
Anxiety symptoms of moderate severity (with or without depressive symptoms) 297683 0
Condition category
Condition code
Mental Health 297858 297858 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy (CBT) delivered in a transdiagnostic group therapy format i.e. for those with any anxiety symptoms of moderate severity (with or without depression).
Two hour sessions weekly for 6 weeks.
Each group will be delivered by two group facilitators. Group facilitators are qualified health professionals experienced in delivering CBT (clinical psychologists, counsellor with post graduate CBT qualifications).
The TCBT treatment package is manualised. An integrity checklist will be used to check that all planned treatment modules are delivered in each session. Adherence will be monitored by attendance, and by self=reported days/week of practice of strategies, assessed from session 2 onwards.
The content of the group includes education about the cognitive behavioural model of anxiety, skills for changing or detaching from unhelpful thinking patterns, learning to face rather than avoid situations, to better tolerate uncomfortable feelings, and developing a plan to maintain changes beyond the group.
Intervention code [1] 293945 0
Treatment: Other
Comparator / control treatment
This is an open label feasibility study with no comparator treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297384 0
Pre-post change on the Kessler Psychological Distress Scale (K-10+)
Timepoint [1] 297384 0
Pre-treatment (Week 0)
Post treatment (Week 6)
Primary outcome [2] 297385 0
Change on the Kessler Psychological Distress Scale (K-10+) from post treatment to follow-up
Timepoint [2] 297385 0
Post treatment (Week 6)
3 month follow-up
Secondary outcome [1] 320920 0
Pre-post change on the Depression, Anxiety Stress Scales (DASS-21)
Timepoint [1] 320920 0
Pre-treatment (Week 0)
Post treatment (Week 6)
Secondary outcome [2] 320921 0
Change in the Depression Anxiety Stress scales (DASS-21) from post treatment to followup
Timepoint [2] 320921 0
Post treatment (Week 6)
3 month follow-up
Secondary outcome [3] 320922 0
Treatment satisfaction. This scale has been designed for this study to assess patient satisfaction with content, therapists, group process, duration of sessions and treatment package, and extent to which they attribute any symptom improvement to the group treatment.
Timepoint [3] 320922 0
Post treatment (week 6)

Eligibility
Key inclusion criteria
Adults; male and female
Moderate anxiety symptoms
Sufficient English language to understand consent form, complete questionnaires and participate in group
Willing to provide informed consent,for the research, willing to participate in group therapy and available to attend all sessions
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In crisis, needing acute intervention, substance dependence or other comorbidity which would interfere with the ability to attend or participate in the groups.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. This is an open label pilot study. Participants referred by general practitioners to the Brief Intervention Counselling Service. Potentially eligible participants will be phoned and screened for eligibility and willingness to do the group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics. Paired t-tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/02/2016
Actual
Date of last participant enrolment
Anticipated
17/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 7597 0
New Zealand
State/province [1] 7597 0
Canterbury

Funding & Sponsors
Funding source category [1] 292906 0
Government body
Name [1] 292906 0
Canterbury District Health Board
Country [1] 292906 0
New Zealand
Primary sponsor type
Government body
Name
Canterbury District Health Board
Address
Canterbury District Health Board
(Planning and Funding)
PO Box 1600
Christchurch
8140
Country
New Zealand
Secondary sponsor category [1] 291653 0
Hospital
Name [1] 291653 0
Anxiety Disorders Service
Address [1] 291653 0
Anxiety Disorders Service
Building 9
Hillmorton Hospital
Private Bag 4733
Christchurch 8140
Country [1] 291653 0
New Zealand
Other collaborator category [1] 278827 0
Other Collaborative groups
Name [1] 278827 0
Brief Intervention Coordination Service
Address [1] 278827 0
Pegasus
P.O Box 741
Christchurch 8140
Country [1] 278827 0
New Zealand
Other collaborator category [2] 278828 0
Individual
Name [2] 278828 0
Claire Gilbert
Address [2] 278828 0
Anxiety Disorders Service
Building 9
Hillmorton Hospital
Private Bag 4733
Christchurch 8140
Country [2] 278828 0
New Zealand
Other collaborator category [3] 278829 0
Individual
Name [3] 278829 0
Alison Alexander
Address [3] 278829 0
Anxiety Disorders Service
Building 9
Hillmorton Hospital
Private Bag 4733
Christchurch 8140
Country [3] 278829 0
New Zealand
Other collaborator category [4] 278832 0
Individual
Name [4] 278832 0
Caroline Bell
Address [4] 278832 0
Anxiety Disorders Service
Building 9
Hillmorton Hospital
Private Bag 4733
Christchurch 8140
Country [4] 278832 0
New Zealand
Other collaborator category [5] 278833 0
Individual
Name [5] 278833 0
Helen Colhoun
Address [5] 278833 0
Anxiety Disorders Service
Building 9
Hillmorton Hospital
Private Bag 4733
Christchurch 8140
Country [5] 278833 0
New Zealand
Other collaborator category [6] 278834 0
Individual
Name [6] 278834 0
Cerina Altenburg
Address [6] 278834 0
Brief Intervention Coordination Service
Pegasus
PO Box 741
Christchurch 8140
Country [6] 278834 0
New Zealand
Other collaborator category [7] 278835 0
Individual
Name [7] 278835 0
Sharen Paine
Address [7] 278835 0
Canterbury Initiative
Canterbury District Health Board
PO Box 1600
Christchurch 8140
Country [7] 278835 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294406 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 294406 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 294406 0
New Zealand
Date submitted for ethics approval [1] 294406 0
16/01/2016
Approval date [1] 294406 0
10/02/2016
Ethics approval number [1] 294406 0
16/NTB/18

Summary
Brief summary
This pilot study will evaluate the delivery of a novel adaptation of a transdiagnostic group cognitive behavioural treatment for 40 adults with mixed anxiety disorders (with or without depressive symptoms) of moderate severity treated in a primary care setting.: the Brief Intervention Coordination Service (BIC, Pegasus). The study will address feasibility and acceptability for participants and provide preliminary estimates of efficacy in reducing psychological distress, ahead of a planned randomised controlled trial.
Anxiety symptoms, and mixed anxiety and depressive symptoms of moderate severity are the most common mental health conditions in the community, with high unmet need in primary care. This is an important public health concern due to the high prevalence, chronicity, impairment in quality of life and socioeconomic costs. Primary care counselling services are strained due to high demand.
The Anxiety Disorders Service (CDHB) successfully developed and evaluated a transdiagnostic group cognitive behaviour therapy (TCBT) treatment for mixed anxiety disorders, with or without depression. The package was adapted from the Unified Protocol for transdiagnostic treatment of emotional disorders (David Barlow and colleagues 2010, 2011) .The TCBT package was effective and rated highly by participants with significant service efficiencies. This TCBT group has been adapted for this project to provide a shorter but sufficiently intense treatment for the moderate symptom group that may not be adequately treated by the limited number of counselling sessions (up to 5 hours) currently available in primary care. The efficiencies of group treatment mean that this evidenced-based treatment can be delivered with fewer staff resources yet patients receive at least twice the therapy hours compared to usual BIC treatment.
Four group programmes (6 x 2 hour sessions) will be run with 10 participants per group. Treatment will be delivered jointly by staff from BIC and from the Anxiety Disorders Service. Primary outcome is the Kessler Psychological Distress Scale (Kessler 10+) assessed pre-post and at 3- month follow-up. If successful, the TCBT approach has the potential to boost routine service delivery in primary care. Early effective treatment may prevent the need for referrals to secondary services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63618 0
Dr Jennifer Jordan
Address 63618 0
Clinical Research Unit
Canterbury District Health Board &
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 63618 0
New Zealand
Phone 63618 0
+64 3 3720400
Fax 63618 0
+64 3 3720407
Email 63618 0
[email protected]
Contact person for public queries
Name 63619 0
Dr Jennifer Jordan
Address 63619 0
Clinical Research Unit
Canterbury District Health Board &
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 63619 0
New Zealand
Phone 63619 0
+6433720400
Fax 63619 0
+64 3 3720400
Email 63619 0
[email protected]
Contact person for scientific queries
Name 63620 0
Dr Jennifer Jordan
Address 63620 0
Clinical Research Unit
Canterbury District Health Board &
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 63620 0
New Zealand
Phone 63620 0
+64 3720400
Fax 63620 0
+64 3 3720407
Email 63620 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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