Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000138886p
Ethics application status
Submitted, not yet approved
Date submitted
6/11/2020
Date registered
11/02/2021
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The talk first study (Korero i te tuatahi when translated in to Maori): A comparison of the efficacy of Behavioural Activation (BA) compared to Sertraline (a medication) in the treatment of low mood.
Scientific title
A Randomised Controlled Trial comparing changes in the Patient Health Questionnaire Depression Scale (PHQ-8) scores after treatment with Behavioural Activation (BA) or Sertraline in patients with a low mood'.
Secondary ID [1] 302721 0
Nil known
Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1260-8739
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low mood 319637 0
depression 319988 0
Condition category
Condition code
Mental Health 317578 317578 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is based on the work of Kirk Strosahl, who developed the therapy known as Focused Acceptance and Commitment Therapy (FACT) which is modified Acceptance and Commitment therapy for primary care. Each eligible intervention patient will get a work/love/play assessment (available from www.brucearroll.com free of charge) which checks on a 1 to 10 scale for how daily life (work, study etc.) is going, love as in friends, love as in intimates, love as in family and play (recreation hobbies etc.). This will be done by the research assistant or one of the investigators on a one on one basis. There will also be open-ended questions on exercise, smoking, sleep, recreational drugs, alcohol, gambling issues in self or family, violence, citizenship/community involvement and if there is a spiritual/religious component to their lives and if they have any unresolved trauma. The purpose of this assessment is to determine the avoidance e.g. not seeing their friends or escape behaviours (e.g. excessive alcohol) and to reverse some or all of those behaviours. Motivational interviewing techniques will be used to reverse these behaviours and patients will be asked what they would be willing to change (based on their work love play responses) and then how likely on a scale of 1 to 10 they will do this in the next 1 -2 weeks. A score of 7 or more is required; otherwise the interviewer will renegotiate the activity until they get a score of 7 or more. The avoidance and escape behaviours will be used as a target for behavioural change using a task sheet for homework. This is a blank piece of paper on which the researcher writes "Task list" and asks the patient what they are willing to change (focusing on the behaviours and escapes that need reversing. Up to four behaviours will be recorded on the list and the score out of 10 for how likely they are to be done. The intervention will be done on the day of enrolment and face to face where possible. Where this is not possible, it will be done either by phone or by a later face to face appointment. The duration of the intervention will be about 10 minutes, with an additional 10 minutes to complete the study documentation forms and questionnaires. The interviews will be done in a GP clinic in a separate room. At two weeks and six weeks, a repeat of the intervention will be given to those who score ten or more on the PHQ 8 at those visits or in any patient who would like a further intervention. Fidelity to the intervention protocol will be done on 10% of participants via a consented recording.
Intervention code [1] 319000 0
Treatment: Other
Comparator / control treatment
The comparator group will be given a bottle of pills containing 50 mg of sertraline and instructed to take 1 tablet daily (preferably in the morning) and then after 7 days increase this to 2 tablets per day (100 mg) for the remaining 11 weeks.
Control group
Active

Outcomes
Primary outcome [1] 325621 0
Depression as measured by a PHQ 8 score
Timepoint [1] 325621 0
Baseline, 6 weeks and 12 weeks post-Intervention initiation i.e. Behavioural Activation initiation and sertraline starting.
Primary outcome [2] 325930 0
Proportion of participants with PHQ 8 less than or equal to 6 post-Intervention initiation i.e. Behavioural Activation initiation and sertraline starting
Timepoint [2] 325930 0
2, 6 and 12 weeks post-Intervention initiation i.e. Behavioural Activation initiation and sertraline starting
Secondary outcome [1] 389566 0
anxiety levels measured by GAD-7 score
Timepoint [1] 389566 0
2 and 6 and 12 weeks post-Intervention initiation i.e. Behavioural Activation initiation and sertraline starting
Secondary outcome [2] 389567 0
Emotional quality of life is being measured by Emoqol 100
Timepoint [2] 389567 0
2 and 6 and 12 weeks post-Intervention initiation i.e. Behavioural Activation initiation and sertraline starting

Eligibility
Key inclusion criteria
Able to read and write English
Understand the patient information sheet
PHQ 8 greater than or equal to 10
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Received antidepressant medication in the past 8 weeks
Suffer from severe psychiatric disorders or substance abuse
any medication contraindicated with sertraline or allergies to sertraline
Pregnant or postnatal women
PHQ 8 greater than or equal to 21 (max score 24)
GAD 7 greater than or equal to 18 (max score 21)
bleeding disorders, severe liver disease or arrhythmias
currently taking antispsychotic medication
currently seeing a psychologist or waitlisted to see one or doing online psychotherapy
patients GP not keen on them being in the study
current suicidal plans

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)
Remote computer supplied by the National Institute of Health Innovation at the Universtiy of Auckland
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients are randomised to the control group or treatment arm(s) by
way of the standard built-in random number generator on the server.
This produces a random number between zero (assignment to the
control group) and the number of treatment arms (assignment to the
intervention arm). Each time the application launches, the random
number generator is initialized with a random value, which is obtained
from the system clock.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
28/05/2021
Actual
Date of last data collection
Anticipated
20/08/2021
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment outside Australia
Country [1] 23095 0
New Zealand
State/province [1] 23095 0
Auckland

Funding & Sponsors
Funding source category [1] 307149 0
University
Name [1] 307149 0
University of Auckland new Staff Grant
Country [1] 307149 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 307745 0
None
Name [1] 307745 0
Address [1] 307745 0
Country [1] 307745 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307262 0
HDEC National Ethics Committee
Ethics committee address [1] 307262 0
Health and Disability Ethics Committee
PO Box 5013
The Terrace
Wellington 6011
Ethics committee country [1] 307262 0
New Zealand
Date submitted for ethics approval [1] 307262 0
03/12/2020
Approval date [1] 307262 0
Ethics approval number [1] 307262 0

Summary
Brief summary
The study will be conducted using a 2-arm parallel group randomised controlled trial. Randomisation will be at the level of the individual patient.
Depressed/low mood participants will be offered one of two interventions. One group will get the work/love/play assessment followed by behavioural activation to reverse the avoidance and escape behaviours, and the control group get sertraline antidepressant medication 50 mg tablet for the first week followed by 2 tablets daily for the subsequent 11 weeks. This study is aimed to see if offering a Behavioural Activation (e.g. exercise, catching up with friends, doing pleasurable activities) intervention is a effective or more effective than prescribing antidepressants to patients with low mood in primary care settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106610 0
Dr Rachel Roskvist
Address 106610 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 106610 0
New Zealand
Phone 106610 0
+64 9 3737599
Fax 106610 0
+64 9 3737624
Email 106610 0
rachel.roskvist@auckland.ac.nz
Contact person for public queries
Name 106611 0
Dr Rachel Roskvist
Address 106611 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 106611 0
New Zealand
Phone 106611 0
+64 9 3737599
Fax 106611 0
+64 9 3737624
Email 106611 0
rachel.roskvist@auckland.ac.nz
Contact person for scientific queries
Name 106612 0
Dr Rachel Roskvist
Address 106612 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 106612 0
New Zealand
Phone 106612 0
+64 9 3737599
Fax 106612 0
+64 9 3737624
Email 106612 0
rachel.roskvist@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All baseline and outcome data
When will data be available (start and end dates)?
Start date 1/3/2021 to 31 December 2021
Available to whom?
To legitimate researchers
Available for what types of analyses?
We would be keen to work with others wanting to do individual patient data meta-analyses
How or where can data be obtained?
From Dr Rachel Roskvist by email Rachel.roskvist@auckland.ac.nz


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
No additional documents have been identified.