Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001403123
Ethics application status
Approved
Date submitted
23/09/2019
Date registered
14/10/2019
Date last updated
14/10/2019
Date data sharing statement initially provided
14/10/2019
Date results provided
14/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Efficacy of Motivational Interviewing as an adjunct to Cognitive Behaviour Therapy for Anxiety Disorders
Scientific title
The Efficacy of Motivational Interviewing as an adjunct to Cognitive Behaviour Therapy for Anxiety Disorders
Secondary ID [1] 299378 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 314544 0
Condition category
Condition code
Mental Health 312889 312889 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recent meta-analytic findings suggest that Motivational Interviewing (MI) used as an
adjunct to Cognitive Behavior Therapy (CBT) for anxiety disorders improves overall
treatment outcomes (Marker & Norton, 2018). However, when used as a prelude to CBT, MI
significantly increases the length of treatment and numerous studies note that the
effectiveness of pre-treatment MI subsides over time. The current study adapted an already
established 12-session transdiagnostic CBT protocol (tCBT, Norton, 2012) which includes psychoeducation (session 1), cognitive restructuring (sessions 2-3), exposure (sessions 4-9), core belief work (sessions 10-11), and relapse prevention (session 12).
The protocol was adapted to include one hour of MI spread across four sessions of tCBT (sessions 1, 3, 8, and 10) at 15 minutes each (min 10 minutes; max 20 minutes). MI strategies were based on the MI for Anxiety Manual by Westra and Dozois (2003). Strategies included a discussion on the pros and cons of change, values and goal exploration, and the elicitation of change talk. MI was used at the start of sessions 1, 3, 8, and 10, and then was followed by CBT. CBT was used in other sessions.
All sessions were conducted in an individual format. Sessions were 1 hour in length, and ran weekly for 12 weeks. Treatment also involved Homework requiring approximately 10-15 minutes of participant time per day. Homework was different each week and related to the content of the therapy session e.g. symptom monitoring (week 1), thought diary (week 2-3), exposures (week 4-9), challenging core beliefs (week 10-11).
All sessions took place at the Monash FEAR Clinic (Notting Hill, VIC). Therapy was carried out by Clinical Psychology Doctoral students under the supervision of a registered clinical psychologist. All sessions were video recorded and fidelity and treatment integrity was assessed using the Motivational Interviewing Treatment Integrity (MITI) Coding manual. Fidelity was assessed by a postgraduate student blind to treatment condition.
Intervention code [1] 315641 0
Behaviour
Intervention code [2] 315798 0
Treatment: Other
Comparator / control treatment
The control condition also received tCBT as per the tCBT manual, psychoeducation was added at sessions 1, 3, 8, and 10 for 15 minutes to control for therapist time.
Control group
Active

Outcomes
Primary outcome [1] 321494 0
Anxiety Disorder Interview Schedule for DSM-5 Clinician Severity Rating
Timepoint [1] 321494 0
Immediately Post Treatment (week 12)
Secondary outcome [1] 375135 0
Clinical Global Impressions - Severity (symptom severity)
Timepoint [1] 375135 0
Immediately Post-Treatment (week 12)

Eligibility
Key inclusion criteria
DSM-5 Principal Anxiety Disorder Diagnosis
18 years or older
Adequately proficiency in English to participate in treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia or other neurocognitive disorders that could impair their ability to provide informed consent or actively engage in treatment
Serious suicidality, substance use requiring detoxification, or any other condition that warranted immediate intervention

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Hierarchical linear modelling
36 participants, 18 in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/08/2016
Date of last participant enrolment
Anticipated
Actual
8/05/2018
Date of last data collection
Anticipated
Actual
18/12/2018
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28110 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 303893 0
Government body
Name [1] 303893 0
Australian Government Research Training Program (RTP) Scholarship
Country [1] 303893 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd,
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 304042 0
None
Name [1] 304042 0
Address [1] 304042 0
Country [1] 304042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304399 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 304399 0
Ethics committee country [1] 304399 0
Australia
Date submitted for ethics approval [1] 304399 0
03/12/2015
Approval date [1] 304399 0
11/01/2016
Ethics approval number [1] 304399 0
CF15/3829 - 2015001674

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96810 0
Prof Peter Norton
Address 96810 0
18 Innovation Walk
Monash University
Clayton, VIC 3800
Country 96810 0
Australia
Phone 96810 0
+61 3 9905 1709
Fax 96810 0
Email 96810 0
[email protected]
Contact person for public queries
Name 96811 0
Isabella Marker
Address 96811 0
18 Innovation Walk
Monash University
Clayton, VIC 3800
Country 96811 0
Australia
Phone 96811 0
+61 3 9902 4480
Fax 96811 0
Email 96811 0
[email protected]
Contact person for scientific queries
Name 96812 0
Peter Norton
Address 96812 0
18 Innovation Walk
Monash University
Clayton, VIC 3800
Country 96812 0
Australia
Phone 96812 0
+61 3 9905 1709
Fax 96812 0
Email 96812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidential patient information


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5038Ethical approval    378438-(Uploaded-23-09-2019-21-54-59)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.