Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000859886
Ethics application status
Approved
Date submitted
31/07/2012
Date registered
15/08/2012
Date last updated
15/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of a modified neurolinguistic programming technique to improve emotional control in patients with depression in primary care.
Scientific title
For patients with depression in primary care with a PHQ-9 score between 10 and 20 will be given a modified neurolinguistic programming 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 6 weeks of a PHQ-9 score <7 and the dichotomous outcome of do you feel in control of your emotions yes/no
Secondary ID [1] 280942 0
There are no other IDs
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression in primary care with a Patient Health Questionnaire score of between 10 and 20 (mild to moderate major depression) 287037 0
depression 287156 0
Condition category
Condition code
Mental Health 287366 287366 0 0
Depression
Mental Health 287476 287476 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions
1.Coached in a drug free process coaching the client (one on one basis) on how to take themselves out of a state of depression with a process from Neuro-linguistic Counselling underlied with Neurolinguistic Programming (NLP). The clients will be shown a video coaching them through what depression is and a strategy for transitioning from depression to being happy. 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. Follow up by text reminding of the skills they have learned with a short statement.
f. One week follow up to check client progress and reinforce their new awareness.
g. A final interview at the end of the 6 week clinical trial.
h. The intervention group will also get the sleep and exercise programme

2. Ask the participant what message they would like to give the world eg I am an interesting person; I am capable and competent. The ask them to put that message on their forehead eg figuratively tatooed on their forehead.
The intervention will take about 45 minutes (including coaching and consenting and gathering of baseline information) to administer along with the questionnaires for the study. At the later visits the duration will be about 30 minutes. The training will be done by a linguistic Programming (NLP) therapist.
Intervention code [1] 285376 0
Behaviour
Intervention code [2] 285481 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
Period.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, delaying sleep onsetexercise late in the evening

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. The time taken to give the control intervention at the first visit will be about 15 minutes and at visits at 1 week 13 weeks they will take 5 to 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 287637 0
Patient Health Questionniare (PHQ-9 <7) at 6 weeks and a yes no to the question do you feel in control of your emotions
Timepoint [1] 287637 0
6 weeks and 13 weeks
Secondary outcome [1] 298567 0
Generalised anxiety disorder questionnaire (GAD-7 )(anxiety score) < 7
Timepoint [1] 298567 0
6 and 13 weeks

Eligibility
Key inclusion criteria
Inclusion criteria
1. Patients in primary care aged 16 and over with a PHQ-9 depression inventory of between 10 and 20. A GAD-7 will also be administered (this is a measure of anxiety).
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 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(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 one of the treatment arms). 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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4452 0
New Zealand
State/province [1] 4452 0

Funding & Sponsors
Funding source category [1] 285729 0
Self funded/Unfunded
Name [1] 285729 0
Bruce Arroll
Country [1] 285729 0
New Zealand
Funding source category [2] 285731 0
University
Name [2] 285731 0
University of Auckland
Country [2] 285731 0
New Zealand
Primary sponsor type
Individual
Name
Prof Bruce Arroll
Address
Prof Bruce Arroll
University of Auckland
Private Bag 92109
Auckland
Country
New Zealand
Secondary sponsor category [1] 284556 0
None
Name [1] 284556 0
Address [1] 284556 0
Country [1] 284556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287736 0
Health and Disability Ethics Committe
Ethics committee address [1] 287736 0
1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 287736 0
New Zealand
Date submitted for ethics approval [1] 287736 0
01/07/2012
Approval date [1] 287736 0
27/07/2012
Ethics approval number [1] 287736 0
12/CEN/3

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. Depresssed participants will be offered one of two interventions to make them blind to their actual intervention. Intervention: One group will get the modified NLP technique, and the control group will be usual care. (Participants will be encouraged not to change their medication during the study and if they choose to do so to discuss that with their GP).
Trial website
www.drugfreedepression.com
Trial related presentations / publications
None yet
Public notes

Contacts
Principal investigator
Name 34511 0
Address 34511 0
Country 34511 0
Phone 34511 0
Fax 34511 0
Email 34511 0
Contact person for public queries
Name 17758 0
Bruce Arroll
Address 17758 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 17758 0
New Zealand
Phone 17758 0
+64-9-9236978
Fax 17758 0
+64-9-3737624
Email 17758 0
[email protected]
Contact person for scientific queries
Name 8686 0
Bruce Arroll
Address 8686 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 8686 0
New Zealand
Phone 8686 0
+64-9-9236978
Fax 8686 0
+64-9-3737624
Email 8686 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

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

Documents added automatically
No additional documents have been identified.