Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000711516
Ethics application status
Not yet submitted
Date submitted
29/06/2015
Date registered
9/07/2015
Date last updated
9/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
RECHARGE: A Behavioural Regulation Program for Young Persons with Depression
Scientific title
RECHARGE: A Behavioural Regulation Program Targeting Circadian Desynchrony in Young Persons with Depression
Secondary ID [1] 286992 0
NIL
Universal Trial Number (UTN)
U1111-1171-6564
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 295454 0
Condition category
Condition code
Mental Health 295710 295710 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main objective of this study is to evaluate whether a behavioural regulation program called RECHARGE that targets desynchrony in circadian rhythms can reduce depressive symptoms in young persons with depression. Specifically, this study will aim to restore circadian rhythm synchrony using RECHARGE, and improve depression as a result of restored circadian rhythm synchrony.

For this pilot phase of the study, we aim to recruit 20 participants. This small sample size was chosen to study the success of this novel behavioural regulation program as a pilot for a future study with a larger sample size.

Before the commencement of the study, participants will be asked to wear a wrist activity and light monitor, called an actigraphy watch. This is like a small watch worn on your non-dominant wrist, and will be worn for approximately 14 days before the beginning of the program. Participants will also be asked to complete a series of questionnaires and tests of mental and physical health.

After two weeks of wearing the watch, the 8-week behavioural regulation program will begin. At Week 1 of the program, participants will attend a 2 hour introductory group learning and training workshop. This group workshop (four persons) will involve engaging in an interactive educational session about the 24 hour body clock, how it can become “desynchronised”, and strategies you can use to resynchronise it. Following this, training will be given on how to operate the iPhone application, “Recharge”, which will be used across the course of the study. This application creates a personalised six-week program to help resynchronise the 24 hour body clock, and monitors daily progress and provides participants with feedback over the six weeks. “Recharge” includes the development of a personalised day and night activity schedule, alarm clock that triggers fun activities to get you up and out of bed, reminders and tips to increase your exposure to daylight in the early hours of the day, physical exercise games to get you moving across the day, wellbeing guidebook providing information and tips on sleep basics, mood, exercise, eating well, and light exposure, daily check-ins to track mood, energy, exercise, and sleep, and graphs and charts to help monitor progress. At the end of the workshop, participants will be asked to wear the actigraphy watch for a further two weeks of monitoring.

At Week 3, participants will attend a 1 hour individual behavioural regulation session with the research investigator. This will involve a personalised analysis of the results from the “Recharge” app and actigraphy watch from the previous 14 days. Currently used behavioural regulation strategies (including those learnt in the initial group workshop) will be discussed for effectiveness and suitability, and novel personalised strategies will be taught depending on the “Recharge” app and actigraphy watch results. Finally, personalised goals for sleep, wake, exercise, and light exposure will be set for the following two weeks. At the end of the session, participants will be asked to wear the watch for a further two weeks of monitoring.

At Week 5, participants will attend a second 1 hour individual behavioural regulation session with the research investigator. Like the first individual session, this will involve a personalised analysis of the results from the “Recharge” app and actigraphy watch. Currently used behavioural regulation strategies will be discussed, and appropriate novel strategies will be taught. Finally, personalised goals for sleep, wake, exercise, and light exposure will be set for the following two weeks. At the end of the session, participants will be asked to wear the watch for a further two weeks of monitoring.

At Week 7, participants will attend a final 2 hour individual behavioural regulation session with the research investigator. In the final session, a personalised analysis of their full six-week “Recharge” app and actigraphy watch results will be conducted. Behavioural regulation strategies used throughout the program will be discussed and refined, and completed and non-completed goals for sleep, wake, exercise, and light exposure will be identified. During the last half of the session, a brief workshop on relapse prevention and management will be given. This will involve a brief education on lapses and relapses and how they occur, and training on specific skills needed to manage a lapse or relapse should one occur after the conclusion of the program. Finally, participants will be asked to fill out a series of questionnaires and tests on mental and physical health. At the end of the session, participants will be asked to wear the watch for a further two weeks of monitoring.

Two weeks after the end of the program, participants will be asked to complete a final follow-up assessment, including wearing the actigraphy watch for two weeks and completing a final series of questionnaires on mental and physical health to examine any changes post-study.
Intervention code [1] 292199 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295413 0
Changes in depression score as assessed by total depression score on Hamilton Rating Scale for Depression (HAMD) and Montgomery-Asberg Depression Rating Scale (MADRS).
Timepoint [1] 295413 0
Baseline, 6-weeks (conclusion of behavioural regulation program), and 8-weeks (two weeks follow-up).
Secondary outcome [1] 315542 0
Changes in cognitive-emotional regulation as assessed by total rumination score on Rumination Response Scale (RRS) and total cognitive-emotional score on Cognitive Emotion Regulation Questionnaire (CERQ).
Timepoint [1] 315542 0
Baseline, 6-weeks (conclusion of behavioural regulation program), and 8-weeks (two weeks follow-up).
Secondary outcome [2] 315543 0
Changes in wellbeing as assessed by total wellbeing score on Quality of Life Enjoyment and Satisfaction Questionnaire -Short Form (Q-LES-Q-SF).
Timepoint [2] 315543 0
Baseline, 6-weeks (conclusion of behavioural regulation program), and 8-weeks (two weeks follow-up).
Secondary outcome [3] 315544 0
Changes in circadian rhythm synchrony as assessed by total score on Morning-Eveningness Questionnaire (MEQ), total sleep-wake score on Pittsburgh Sleep Quality Index (PSQI), and score on circadian paramaters (amplitude, minimum, acrophase, and rhythmicity indices) derived from actigraphy watch results.
Timepoint [3] 315544 0
Baseline, 6-weeks (conclusion of behavioural regulation program), and 8-weeks (two weeks follow-up).
Secondary outcome [4] 315545 0
Changes in manic symptoms as assessed by total mania score on Internal State Scale (ISS).
Timepoint [4] 315545 0
Baseline, 6-weeks (conclusion of behavioural regulation program), and 8-weeks (two-weeks follow-up).

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Aged between 16 and 30.
2. Current diagnosis of major depression (as indicated by treating clinician according to current DSM-V criteria for Major Depressive Disorder (MDD).
3. Current circadian dysrhythmia (as indicated by pre-study actigraphy watch results).
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Not fluent in English
2. Has sleep apnoea
3. Has other primary psychiatric disorders associated with depression (e.g. schizophrenia)
4. Has other major neurological problems (e.g. stroke, epilepsy, head injury)
5. Is dependent on alcohol or illicit substances
6. Engages in regular shift-work
7. Has recently experienced jet lag (you will be required to wait three days for each jet lag hour before entering the study)
8. Does not have an iPhone or iPad

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment will be conducted via clinician referral. Clinicians from the Brain and Mind Clinic and Headspace at Camperdown will identify patients who may be eligible (is within the age range and has a current diagnosis of Major Depressive Disorder) and is interested in participating to this study.

The research team will then approach potential participants who consent to be contacted for study involvement. They will be called by the research investigator via telephone to inform them about the current study and ask questions addressing the inclusion/exclusion criteria.

Individuals who meet the inclusion and exclusion criteria will then be given an actigraphy watch to assess circadian rhythm desynchrony before commencement of the behavioural regulation program.

Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will not be randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Actigraphy data will be analysed using standard algorithms in GraphPad Prism to determine delayed sleep phase, total sleep time, sleep onset and offset, wake after sleep onset, and sleep efficiency. Other circadian parameters (amplitude, minimum, acrophase, and rhythmicity indices) will also be derived from this data using cosinor analysis.

These actigraphy measures, as well as questionnaire data collected from both the clinician-rated and self-report questionnaires will be compared across time points using SPSS v.23 statistical software. Changes in mood, circadian rhythm, cognitive-emotional functioning, and general well-being will be evaluated using repeated measures ANOVA. Mediational analyses will examine potential explanatory pathways, with questions focused on whether change in circadian parameters (derived from both actigraphy and questionnaire data) are causally related to mood outcomes, and if these occur at different time points (post-program compared to follow-up).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291548 0
University
Name [1] 291548 0
The University of Sydney
Country [1] 291548 0
Australia
Primary sponsor type
Individual
Name
Professor Ian Hickie
Address
Brain and Mind Research Institute, The University of Sydney, 94 Mallett Street, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 290225 0
Individual
Name [1] 290225 0
Ashlee Hannon
Address [1] 290225 0
Brain and Mind Research Institute, The University of Sydney, 94 Mallett Street, Camperdown NSW 2050
Country [1] 290225 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293090 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 293090 0
Ethics committee country [1] 293090 0
Australia
Date submitted for ethics approval [1] 293090 0
03/07/2015
Approval date [1] 293090 0
Ethics approval number [1] 293090 0

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

Contacts
Principal investigator
Name 58426 0
Prof Ian Hickie
Address 58426 0
Brain and Mind Research Institute, The University of Sydney, 94 Mallett Street, Camperdown, NSW 2050
Country 58426 0
Australia
Phone 58426 0
+61 2 9351 0810
Fax 58426 0
Email 58426 0
[email protected]
Contact person for public queries
Name 58427 0
Ashlee Hannon
Address 58427 0
Brain and Mind Research Institute, The University of Sydney, 94 Mallett Street, Camperdown, NSW 2050
Country 58427 0
Australia
Phone 58427 0
+61 2 9114 4000
Fax 58427 0
Email 58427 0
[email protected]
Contact person for scientific queries
Name 58428 0
Ashlee Hannon
Address 58428 0
Brain and Mind Research Institute, The University of Sydney, 94 Mallett Street, Camperdown, NSW 2050
Country 58428 0
Australia
Phone 58428 0
+61 2 9114 4000
Fax 58428 0
Email 58428 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

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