Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001085460
Ethics application status
Approved
Date submitted
9/08/2016
Date registered
11/08/2016
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the impact of internal versus external attentional targets on mindfulness skills acquisition in individuals with history of depression or anxiety
Scientific title
Exploring the impact of internal versus external attentional targets on mindfulness skills acquisition in individuals with a history of depression or anxiety
Secondary ID [1] 289892 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mindfulness skills (sustained attention, switching attention, nonelaborative processing) 299844 0
Resilience 299845 0
Depression 299846 0
Anxiety 299847 0
Stress 299848 0
Emotional regulation skills 299849 0
General psychological wellbeing 299850 0
Condition category
Condition code
Alternative and Complementary Medicine 299759 299759 0 0
Other alternative and complementary medicine
Mental Health 299787 299787 0 0
Depression
Mental Health 299788 299788 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will go through eight weekly (1 hour) structured mindfulness sessions. All sessions will be in groups of up to eight participants, and all sessions will involve direct face-to-face contact at Murdoch University (Perth, Western Australia). All sessions will be facilitated by the main student researcher for this study (Leong-Min Loo), who is a provisionally registered clinical psychology PhD student at Murdoch University, Perth, Western Australia. The sessions will also have a co-facilitator (a provisionally registered clinical psychology Masters student). Sessions are supervised by a clinical psychologist. All sessions are structured - with a brief introduction, two scripted mindfulness activities, and two discussion segments. Materials are compiled into a comprehensive protocol. Mindfulness activity scripts are adapted from the book ‘The Mindful Way through Depression: Freeing Yourself from Chronic Unhappiness’.
Participants in this intervention condition (hereby labelled as "sounds") will attend to moment-to-moment progression of unique sound tracks, with each track lasting approximately five to eight minutes long. Each track will only be played once throughout the eight sessions, and each session will have two tracks, except for the eighth session, which will have only one track. All tracks will have low arousal and positive valence.
Participants will be given the Outcome Rating Scale (ORS) at the start of the session. They will be given the Five Facet Mindfulness Questionnaire (FFMQ), Brief Resilience Scale (BRS), Depression Anxiety Stress Scale-21 (DASS-21), and a session rating questionnaire, at the end of the session. Participants will also be emailed handouts containing a summary of the session and suggested mindfulness activities, after every session.
Intervention code [1] 295567 0
Treatment: Other
Comparator / control treatment
All participants will go through eight weekly (1 hour) structured mindfulness sessions. All sessions will be in groups of up to eight participants, and all sessions will involve direct face-to-face contact at Murdoch University (Perth, Western Australia). All sessions will be facilitated by the main student researcher for this study (Leong-Min Loo), who is a provisionally registered clinical psychology PhD student at Murdoch University, Perth, Western Australia. The sessions will also have a co-facilitator (a provisionally registered clinical psychology Masters student). Sessions are supervised by a clinical psychologist. All sessions are structured - with a brief introduction, two scripted mindfulness activities, and two discussion segments. Materials are compiled into a comprehensive protocol. Mindfulness activity scripts are adapted from the book ‘The Mindful Way through Depression: Freeing Yourself from Chronic Unhappiness’.
First, participants will go through two sessions of mindfulness orientation. They will be given information on the theory behind concepts of mindfulness, and will engage in some guided mindfulness exercises, such as a ten-minute Body Scan, and Mindful Eating. After the two orientation sessions, participants will engage in various mindfulness activities focusing on the breath and its accompanying bodily sensations (internal attentional targets).
Participants will be given the Outcome Rating Scale (ORS) at the start of the session. They will be given the Five Facet Mindfulness Questionnaire (FFMQ), Brief Resilience Scale (BRS), Depression Anxiety Stress Scale-21 (DASS-21), and a session rating questionnaire, at the end of the session. Participants will also be emailed handouts containing a summary of the session and suggested mindfulness activities, after every session.
Control group
Active

Outcomes
Primary outcome [1] 299218 0
Mindfulness skills (observing, describing, nonjudgement, nonreactivity, awareness) via the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [1] 299218 0
Baseline (pre-intervention), intervention (week 1, 2, 3, 4, 5, 6, 7, 8), Post-intervention (approx. 1-3 weeks after final intervention session). During the intervention, the FFMQ is administered immediately at the end of the specified sessions.
Secondary outcome [1] 326543 0
Resilience via the Brief Resilience Scale (BRS)
Timepoint [1] 326543 0
Baseline (pre-intervention), intervention (week 1, 2, 3, 4, 5, 6, 7, 8), post-intervention (approx. 1-3 weeks after final intervention session). During the intervention, the BRS is administered immediately at the end of the specified sessions.
Secondary outcome [2] 326544 0
Depression subscore of the Depression Anxiety Stress Scale-21 (DASS-21)
Timepoint [2] 326544 0
Baseline (pre-intervention), intervention (week 1, 2, 3, 4, 5, 6, 7, 8), post-intervention (approx. 1-3 weeks after final intervention session). During the intervention, the DASS-21 is administered immediately at the end of the specified sessions.
Secondary outcome [3] 326545 0
Anxiety subscore of the Depression Anxiety Stress Scale-21 (DASS-21)
Timepoint [3] 326545 0
Baseline (pre-intervention), intervention (week 1, 2, 3, 4, 5, 6, 7, 8), post-intervention (approx. 1-3 weeks after final intervention session). During the intervention, the DASS-21 is administered immediately at the end of the specified sessions.
Secondary outcome [4] 326546 0
Stress subscore of the Depression Anxiety Stress Scale-21 (DASS-21)
Timepoint [4] 326546 0
Baseline (pre-intervention), intervention (week 1, 2, 3, 4, 5, 6, 7, 8), post-intervention (approx. 1-3 weeks after final intervention session). During the intervention, the DASS-21 is administered immediately at the end of the specified sessions.
Secondary outcome [5] 326547 0
Heart rate variability (as an index of emotional regulation and flexibility) is monitored using finger sensors attached to the index, third and ring fingers on the participant's preferred hand (right or left). The sensors are in turn linked to the Alive Programme (Somatic Vision), installed on a Windows 7 laptop. The duration of monitoring is five minutes at each timepoint.
Timepoint [5] 326547 0
Baseline (pre-intervention) and post-intervention (approx. 1-3 weeks after final intervention session).

Eligibility
Key inclusion criteria
Aged 18-65
Normal hearing
History of depression or anxiety, with at least a current presentation of mild to moderate symptoms of depression or anxiety according to Depression Anxiety Stress Scale-42 (DASS-42; score of 10-20 for Depression, and 8-14 for Anxiety)
Understand and read at least conversational English
Stable use of psychopharmacology; on a regular dose for at least four weeks
Comfortable with being in group settings of up to 8 people
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of severe psychopathological disorders that require more specialised and intensive interventions (e.g., psychosis, eating disorders, dissociative disorders, personality disorders, or other mood disorders specified by DSM-5)
Presence of complex trauma, or other trauma-related disorders such as PTSD
Substance and/or alcohol misuse/abuse that require more specialised rehabilitation and/or detoxification
Neurocognitive impairments resulting from organic brain injury, acquired brain injury or dementia
Current and/or ongoing self-harm, suicidal ideation or attempt (within the past 24 months)
Hearing impairments (this includes the use of hearing aids)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers (1 for "control" and 2 for "sounds")
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants were randomly and individually assigned to one out of four group timeslots. Simple randomisation was then done using folded slips of paper labelled with session timeslots. Two session timeslots correspond to "control", another two session timeslots correspond to "music". The folded slips of paper were then shuffled and tossed into each of the labelled containers (Ctrl for "control" and Mus for "sounds"). Each slip is then opened one by one.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori power analysis has not been calculated.
Quantitative data (mindfulness skills, resilience, depression, anxiety and stress) will be converted and analysed via SPSS (PASW) Statistics, following intention to treat analyses, using linear mixed modelling approaches. In addition to intention to treat analyses, additional correlation and regression slope analyses will be carried out to determine relationships between variables.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We performed an initial round of data analysis, following stopping of the trial, and found that the results supported the aims/objectives of our study (pilot randomised controlled trial), and was sufficient for us to evaluate in relation to extant literature.
Date of first participant enrolment
Anticipated
31/10/2016
Actual
17/01/2017
Date of last participant enrolment
Anticipated
14/04/2017
Actual
19/04/2017
Date of last data collection
Anticipated
12/07/2017
Actual
13/07/2017
Sample size
Target
60
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 13994 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 294262 0
University
Name [1] 294262 0
Murdoch University PhD Research Fund
Country [1] 294262 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street
Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 293097 0
None
Name [1] 293097 0
Address [1] 293097 0
Country [1] 293097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295690 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 295690 0
Murdoch University
90 South Street
Murdoch, WA 6150
Ethics committee country [1] 295690 0
Australia
Date submitted for ethics approval [1] 295690 0
01/09/2016
Approval date [1] 295690 0
07/10/2016
Ethics approval number [1] 295690 0
2016/142

Summary
Brief summary
This study seeks to determine if incorporating sounds into mindfulness programmes will serve as viable alternatives in enhancing mindfulness skills acquisition, emotional flexibility, and psychological wellbeing, compared to the breath and body, in participants with a history of depression or anxiety.
Participants will first be screened in a pre-intervention interview (individually conducted) – using the Structured Clinical Interview for DSM-5 (SCID-5), alongside obtaining demographic information such as age, gender, meditation experience, and music experience. From the SCID-5, any participants with severe presentations will be excluded from the study, but will be provided with referral information as necessary. All participants will be informed about the outcome of the SCID-5, within 1-2 weeks of the interview.
Suitable participants will then go through a pre-group session (individually conducted), where they will fill in the Five Facet Mindfulness Questionnaire (FFMQ), Brief Resilience Scale (BRS), and Depression Anxiety Stress Scale-21 (DASS-21). They will also have their heart rate variability taken during the pre-group session. Participants are then randomly allocated (using simple randomisation) to two independent conditions - “active control” (ie. mindfulness activities using the breath and body as attentional targets as per other mindfulness oriented programmes), and “sounds” (mindfulness activities incorporating various sounds as external attentional targets). All participants are blinded to the random allocation process.
Following which, participants will attend eight weekly mindfulness sessions, each lasting one hour each (group settings of up to 8 people). Participants in the “active control” condition will first engage in two weeks of mindfulness familiarisation sessions, followed by six weeks of various guided mindfulness activities using the breath and its accompanying bodily sensations as attentional targets. Participants in the “sounds” condition will engage in two weeks of mindfulness familiarisation sessions, followed by six weeks of various guided mindfulness activities accompanied by unique soundtracks lasting 5-8 minutes long. Each soundtrack is only played once throughout the duration of the intervention. During the intervention, regardless of the condition they are in, all participants fill in an Outcome Rating Scale (ORS) at the start of every session; the FFMQ, BRS, DASS-21 and a session rating questionnaire at the end of every session. All participants will also be given session handouts at the end of each session.
After the intervention, all participants go through a post-group session (conducted individually), which is identical to that of the pre-group session. Participants will be given opportunities to provide feedback regarding the study, during the post-group session.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68130 0
Dr Helen Correia
Address 68130 0
School of Psychology and Exercise Sciences
Murdoch University
90 South Street
Murdoch, WA 6150
Country 68130 0
Australia
Phone 68130 0
+61 8 9360 2290
Fax 68130 0
Email 68130 0
[email protected]
Contact person for public queries
Name 68131 0
Dr Jon Prince
Address 68131 0
School of Psychology and Exercise Sciences
Murdoch University
90 South Street
Murdoch, WA 6150
Country 68131 0
Australia
Phone 68131 0
+61 8 9360 6670
Fax 68131 0
Email 68131 0
[email protected]
Contact person for scientific queries
Name 68132 0
Dr Helen Correia
Address 68132 0
School of Psychology and Exercise Sciences
Murdoch University
90 South Street
Murdoch, WA 6150
Country 68132 0
Australia
Phone 68132 0
+61 8 9360 2290
Fax 68132 0
Email 68132 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.