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Trial registered on ANZCTR


Registration number
ACTRN12617001543370
Ethics application status
Approved
Date submitted
27/10/2017
Date registered
7/11/2017
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Date results information initially provided
6/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of focussed acceptance and commitment therapy on quality of life and depression in patients with depressive symptoms in primary care
Scientific title
Effect of focussed acceptance and commitment therapy on quality of life and depression in patients with depressive symptoms in primary care,
Secondary ID [1] 293229 0
Nil known
Universal Trial Number (UTN)
U1111-1204-3366
Trial acronym
PrimeFACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depressive symptoms 305257 0
Condition category
Condition code
Mental Health 304574 304574 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 Focussed Acceptance and Commitment Therapy (FACT) which is modified Acceptance and Commitment therapy for primary care.
Each patient will get a work/love/play assessment 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.). 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 component to their lives. Any deficit in these aspects of life will be used as a target for behavioural change using a task sheet for homework. The patients will be asked if they can describe the emotional pain that is behind their distress (these are usually in the domains of being unlovable or helpless. They will then be shown the mindful anchor based on Kirk Strosahl’s “Inside this moment” book. This is a five step mindfulness technique designed to enable the patient to be present with their emotional pain and to stop resisting it. They may find it distressing to be asked to make behavioural changes in their lives (their task sheet) and will be advised that when the pain arises they should use the mindful anchor.

The persons who will do the FACT interview will either be GPs with a FRNZCGP or equivalent, a medical graduate with some training in FACT (either the Goodfellow Unit online course) or equivalent or a psychologist with similar training in FACT. The intervention will be delivered once 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. It will be done with individuals not groups. The outcomes will be measured one week after the intervention is given. The duration of the intervention will be about 20 to 30 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.
Intervention code [1] 299486 0
Treatment: Other
Comparator / control treatment
Treatment as usual by their GP or practice nurse. The GP and practice nurse will be notified that the patient is eligible for the study but not be told what intervention the patient is being given.
Control group
Active

Outcomes
Primary outcome [1] 303793 0
Patient Health Questionniare (PHQ-8),
Timepoint [1] 303793 0
One week post- intervention. This may be longer than one week from enrolment as it may not be possible to do the initial interview on the same day as enrolment.
Primary outcome [2] 303794 0
euroquol 5-D depression questions – level changes in one of five levels
Timepoint [2] 303794 0
One week post- intervention. This may be longer than one week from enrolment as it may not be possible to do the initial interview on the same day as enrolment.
Primary outcome [3] 303795 0
Changes in the Euroquol 5D 1 to 100 quality of life scale
Timepoint [3] 303795 0
One week post- intervention. This may be longer than one week from enrolment as it may not be possible to do the initial interview on the same day as enrolment.
Secondary outcome [1] 340184 0
Acceptance and Action version 2 questionnaire.
Timepoint [1] 340184 0
One week post- intervention. This may be longer than one week from enrolment as it may not be possible to do the initial interview on the same day as enrolment.

Eligibility
Key inclusion criteria
1. Patients aged 16 and over with a PHQ-8 from 2 to 21
2. Speak sufficient English (or have an interpreter).
Minimum age
16 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently on current major tranquilizer medication.
2. Unable to comprehend the information sheet.
3. Bipolar affective disorder.
4. Currently accessing psychological treatment.
5. Taking antidepressant medication for less than one month.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use caseweaver.co.nz which is software that allows for blinded
and concealed randomisation once the baseline data has been entered. 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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The analysis will be done by intention to treat analysis. Categorical outcomes will be
expressed using counts (percentages) and compared between treatment groups
using the chi-squared test. Continuous variables were expressed using mean
(standard deviation) and compared between groups using an analysis of variance.
The secondary outcome of GAD will be expressed in medians and compared
between groups using the Mann–Whitney U test. The multivariate models for
the dichotomous outcomes will be evaluated using logistic regression to calculate
odds ratios (which will be converted to risk ratios using the formula of Zhang)
with confidence intervals. The continuous outcomes will be analyzed using multiple
linear regression. All multivariate models controlled for age and gender
(and the baseline levels for the primary outcome of PHQ 8). A two-tailed p
value<0.05 will be considered to be significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The interviewer left and we had a good idea on how our rate of recruiting was going to be for later studies
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] 9324 0
New Zealand
State/province [1] 9324 0
Auckland

Funding & Sponsors
Funding source category [1] 297860 0
Charities/Societies/Foundations
Name [1] 297860 0
Royal New Zealand College ofGPs Auckland Faculty Charitable Trust
Address [1] 297860 0
785 Mt Eden Rd
Auckland
1024
PO Box 56340
Postal code 1024
Country [1] 297860 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Greenstone Family Clinic
Address
PO BOx 75447
Manurewa
Auckland 2102
Country
New Zealand
Secondary sponsor category [1] 296899 0
None
Name [1] 296899 0
Address [1] 296899 0
Country [1] 296899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298905 0
Southern Health and Disability Ethics Committee.
Ethics committee address [1] 298905 0
Health and disability Ethics Committee
Address: 1 The Terrace
PO Box 5013
Welllington 6011
New Zealand

Ethics committee country [1] 298905 0
New Zealand
Date submitted for ethics approval [1] 298905 0
11/02/2017
Approval date [1] 298905 0
05/09/2017
Ethics approval number [1] 298905 0
17/STH/116

Summary
Brief summary
The Primary purpose of this study is to assess the feasibility of recruiting patients from a primary care waiting room when evaluating the effectiveness of Focussed Acceptance and Commitment Therapy (FACT). It is also designed to have sufficient power to determine if there is a benefit from FACT at one week after the interventions.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78614 0
Prof Bruce Arroll
Address 78614 0
University of Auckland
Private Bag 92109
Auckland 1142
Country 78614 0
New Zealand
Phone 78614 0
+64-9-9236978
Fax 78614 0
+64-9-3737624
Email 78614 0
bruce.arroll@auckland.ac.nz
Contact person for public queries
Name 78615 0
Prof Bruce Arroll
Address 78615 0
University of Auckland
Private Bag 92109
Auckland 1142
Country 78615 0
New Zealand
Phone 78615 0
+64-9-9236978
Fax 78615 0
+64-9-3737624
Email 78615 0
bruce.arroll@auckland.ac.nz
Contact person for scientific queries
Name 78616 0
Prof Bruce Arroll
Address 78616 0
University of Auckland
Private Bag 92109
Auckland 1142
Country 78616 0
New Zealand
Phone 78616 0
+64-9-9236978
Fax 78616 0
+64-9-3737624
Email 78616 0
bruce.arroll@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 study data
When will data be available (start and end dates)?
1 may 2019
it will be available indefinitely
Available to whom?
to whomever makes the case for having the data
Available for what types of analyses?
any analysis
How or where can data be obtained?
email
What supporting documents are/will be available?
Study protocol
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary