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RECHARGE: A Behavioural Regulation Program for Young Persons with Depression

RECHARGE: A Behavioural Regulation Program Targeting Circadian Desynchrony in Young Persons with Depression

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000711516
Enrollment
20
Registered
2015-07-09
Start date
2015-07-31
Completion date
Unknown
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, RECHARGE is an investigation of a novel 8-week behavioural regulation program targeting circadian rhythm desynchrony and its impact on depressive symptomology in young people with depression. It is the aim of the study to evaluate the 8-week behavioural regulation program and its impact on depression, and identify whether targeting circadian rhythm desynchrony (and its related improvements in circadian rhythm) are associated with improvements in depression.

Interventions

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 suc

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.

Sponsors

Professor Ian Hickie
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 30 Years
Healthy volunteers
No

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).

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026