Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000756628
Ethics application status
Approved
Date submitted
30/05/2014
Date registered
16/07/2014
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of a novel visualisation technique to improve emotional control in patients with depression in primary care.
Scientific title
Patients with depression in primary care with a PHQ-9 score between 10 and 20 will be given a novel visualisation technique and advised to exercise regularly and given sleep hygiene advice versus advised to exercise regularly and given sleep hygiene advice with the outcome at 8 weeks of a PHQ-9 score <7 or a score of < 6 on the self reported Montgomery-Asberg scale.
Secondary ID [1] 284703 0
There are no other IDs
Universal Trial Number (UTN)
U1111-1157-5486
Trial acronym
Noval Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292056 0
Condition category
Condition code
Mental Health 292395 292395 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions (known as the Noval technique)
1.Coached in a drug free process for the client (one on one basis) on how to take themselves out of a state of depression with a novel visualisation technique. The clients will be coached through what depression is and a strategy for transitioning from depression to being happy using the novel visualisation technique. Clients will get to observe themselves internally as they transition through these states.
a. Observing a state that is symptomatic of depression.
b. Observe a state that is symptomatic of being happy.
c. Coached on how to get out of the state of being depressed.
d. Coached on staying in a state of being happy.
e. One week follow up to check client progress and reinforce their new awareness.
g. A final interview at the end of the 8 week clinical trial.
h. The intervention group will also get the sleep and exercise programme.
The intervention group will be a one time intervention at baseline lasting appromximately 45 minutes. The sleep and exercise programme is the same for intervention and control groups. There are no stategies to monitor adherence. We are testing a one off Noval as the intervention. The verbal advice will be given face to face and this takes about 15 minutes.
Intervention code [1] 289490 0
Behaviour
Intervention code [2] 289491 0
Treatment: Other
Comparator / control treatment
Sleep and Exercise Programme-for intervention and control group
1.”Sleep hygiene” instructions and rationale
Instruction Rationale
Caffeine and nicotine are stimulants that can delay sleep onset and impair sleep quality; people vary in their ability to metabolise these substances from their system; some people use alcohol to help them get to sleep because it relaxes them, but it may cause awakenings and reduce sleep quality later in the sleep. Therefore limit of caffeine to 1 cup of coffee in the morning (if at all), avoid alcohol and cigarettes at night, and limit other substances that can affect sleep. People do not fall asleep if their brain is wide awake, so going to bed before they are sleepy leads to frustration at not being able to sleep, which can further delay sleep onset; peoples sleep patterns and needs may not match those of their bed partners

Avoid going to bed until you are drowsy and ready to sleep

Napping reduces the “sleep pressure” that builds up during the day to the point where a threshold is reached and we are ready to sleep; napping may delay the time of readiness for sleep and lead to erratic bedtimes, especially if the person can sleep in to compensate for a later bedtime (leading to a “domino” effect for the day after); if naps have been taken during the day, and the “usual” bedtime is kept, sleep onset may be delayed, leading to frustration and anxiety, which further prolongs sleep onset.

Avoid napping during the day

Regular daily exercise can help improve sleep, but avoid Exercise, too close to a sleep period, can serve as an arousal stimulus.

The bed should be comfortable, the temperature not too hot or cold, the room dark, and noise minimised;discomfort, being too hot or cold, noise, and light can disrupt sleep.

Ensure that the bedtime environment is comfortable and
conducive to sleep

Looking at a computer screen in the hours before bed may delay sleep onset (the light waves emitted are thought to reduce the production of melatonin, a hormone that is secreted by the pineal gland to promote sleep); looking at a clock during awakenings can delay sleep onset by contributing to frustration at being awake (lit clocks may also contribute arousal stimuli to the brain); if co-sleepers are disturbing sleep (by excessive movements or snoring) they probably warrant their own assessment for sleep disorders

Think about computer screens, clocks, and co-sleepers
The thought behind this idea is that bed needs to be associated with being asleep not with being awake and having difficulty getting to sleep. If not asleep within 15-20 minutes, get out of bed and return only when drowsy.

3. Exercise
a. Participants will be asked to do regular exercise that involves an activity such as brisk walking for 30 minutes at least 3 times per week.

4. Both intervention and control group get the sleep and exercise advice-verbally by face to face interaction. This is done as a one off intervention and not repeated. There is no mechanism to monitor their adherence.
Control group
Active

Outcomes
Primary outcome [1] 292256 0
Patient Health Questionniare (PHQ-9 <7) at 8 weeks or < 6 on the Self reported Montgomery-Asberg scale
Timepoint [1] 292256 0
8 weeks
Secondary outcome [1] 308564 0
Generalised anxiety disorder questionnaire (GAD-7 )(anxiety score) < 7
Timepoint [1] 308564 0
8 weeks

Eligibility
Key inclusion criteria
Inclusion criteria
1. Patients aged 16 and over with a PHQ-9 depression inventory of between 10 and 20.
2. Speak sufficient English (or have an interpreter).
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Currently on current major tranquilizer medication.
2. Intoxication, dementia and terminal illness.
3. Bipolar affective disorder, PHQ-9 scores < 10 or > 20.
4. Currently actively suicidal.
5. Psychotic disorder.

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)
We will use caseweaver.com which is software that allows for blinded and concealed randomisation once the baseline data has been entered
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients are randomised to the control group or treatment arm 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 one (assignment to the intervention arm-there are only two arms to this trial). 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
Continuous measures will be summarised as numbers of observed and missing values (n, mean, standard deviation, median, minimum and maximum.) All statistical tests will be two-tailed. Logistic regression models will also be used for the primary and secondary outcomes to adjust for clinically important baseline variables. We expect 50% of the control group to improve and 79% of the intervention group to improve which means we need 48 participants each in the two arms beta 0.2 alpha 0.05.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
this study never started due to ill health of the PI
Date of first participant enrolment
Anticipated
31/07/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
122
Accrual to date
Final
Recruitment outside Australia
Country [1] 6080 0
New Zealand
State/province [1] 6080 0

Funding & Sponsors
Funding source category [1] 289324 0
Other Collaborative groups
Name [1] 289324 0
Royal New Zealand College of GPs Auckland Faculty Trust
Country [1] 289324 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Prof Bruce Arroll
University of Auckland
Private Bag 92109
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288010 0
Other Collaborative groups
Name [1] 288010 0
Royal New Zealand College of GPs Auckland Faculty Trust
Address [1] 288010 0
Dr J lello
Physical Address
785 Mt Eden Road
Auckland 1024

Post address
Mt Eden Auckland
Po Box 56340
1024
Country [1] 288010 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291090 0
Health and disability Ethics Committee
Ethics committee address [1] 291090 0
Ethics committee country [1] 291090 0
New Zealand
Date submitted for ethics approval [1] 291090 0
02/07/2012
Approval date [1] 291090 0
27/07/2012
Ethics approval number [1] 291090 0
12-CEN-3

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

Contacts
Principal investigator
Name 48850 0
Prof Bruce Arroll
Address 48850 0
Department of General Practice and Primary Health Care University of Auckland Private Bag 92019 Auckland 1142
Country 48850 0
New Zealand
Phone 48850 0
+64-9-9236978
Fax 48850 0
+64-9-3737624
Email 48850 0
[email protected]
Contact person for public queries
Name 48851 0
Bruce Arroll
Address 48851 0
Department of General Practice and Primary Health Care University of Auckland Private Bag 92019 Auckland 1142
Country 48851 0
New Zealand
Phone 48851 0
+64-9-9236978
Fax 48851 0
+64-9-3739624
Email 48851 0
[email protected]
Contact person for scientific queries
Name 48852 0
Bruce Arroll
Address 48852 0
Department of General Practice and Primary Health Care University of Auckland Private Bag 92019 Auckland 1142
Country 48852 0
New Zealand
Phone 48852 0
+64-9-9236978
Fax 48852 0
+64-9-3737624
Email 48852 0
[email protected]

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


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.