A randomized controlled trial of a novel visualisation technique to improve emotional control in patients with depression in primary care.

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.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000756628

Acronym

Noval Trial

Enrollment

122

Registered

2014-07-16

Start date

2014-07-31

Completion date

2015-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 the NoVal technique, and the control group will be usual care. Both groups will get exercise and sleep advice in addition to the Noval and the usual care (control group).

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to 75 Years

Healthy volunteers

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).

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.

Outcome results