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Trial registered on ANZCTR


Registration number
ACTRN12617000424303
Ethics application status
Approved
Date submitted
10/03/2017
Date registered
24/03/2017
Date last updated
24/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Ajapa Japa Meditation on Symptoms of Anxiety Disorder
Scientific title
The efficacy of Ajapa Japa Meditation on Anxiety Symptoms in patients with Anxiety
Secondary ID [1] 291386 0
-
Universal Trial Number (UTN)
U1111-1193-9881
Trial acronym
-
Linked study record
-

Health condition
Health condition(s) or problem(s) studied:
anxiety 302435 0
Condition category
Condition code
Mental Health 302006 302006 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aims of the project:

This research study intends to evaluate the efficacy of an 8-week yoga meditation intervention utilising an ancient meditation technique known as Ajapa Japa in reducing anxiety, sleep problems, improving quality of life and increasing trait mindfulness for individuals with Anxiety Disorders. This meditation technique has never previously been used with Anxiety Disorder patients.

Research Design:

Participants:
The participants will be volunteers from St John of God Outpatient programs (SJOG) who have Anxiety Disorders, who are 18 years or older, English speakers, have not had a previous psychotic episode and who are not experienced meditators.
Method:
These participants will perform the Ajapa japa meditation at least three times a week over 8 weeks. The meditation in total would take 15 minutes per session. The participants will be lead in person through the meditation by the student researcher Sally Blair once a week in the Outpatient Hospital suite. The other 2 meditations will be done by way of an audio meditation which is lead by Dr Swami Shankadev who is a medical doctor, a yoga swami and psychotherapist who lives and works in Sydney. The participants will receive the meditation via google drive and will download it onto their computer or personal device. The participants will perform track 3 and 4 of the meditation a minimum of twice a week at a time and place of their choosing. Thus, the participants will have one live session of meditation at the hospital per week and do two audio sessions of meditation a time and place of their choosing at least twice per week.

Adherence to the meditation will be assessed by asking the participants to complete a sheet determining a) how many times they did the meditation 2) whether they were engaged in the meditation in a mindful fashion or not. These sheets will be returned to the student researcher after 8 weeks.

Importantly, the participants will be still receiving their usual outpatient treatment throughout the 8-week period.

Intervention code [1] 297460 0
Treatment: Other
Comparator / control treatment
Control Groups:
The control groups for this experiment would consist of a waitlist group from the outpatients programs at SJOG Burwood who are currently participating in treatment as usual in their Outpatient Group.

The control group will be sent the meditation intervention by way of Google Drive following the 12 week follow-up period.

The usual treatment is a CBT-based outpatient group therapy for individuals with Anxiety Disorders. Topics covered include:
understanding anxiety
dealing with anxiety
managing anxious and negative thoughts
relaxation strategies and other stress management techniques
mindfulness meditation and skills.
Control group
Active

Outcomes
Primary outcome [1] 301432 0
The Beck Anxiety Inventory (BAI: Beck, Epstein, Brown, & Steer, 1988). The BAI is a brief 21-item questionnaire that assesses anxiety symptoms (0-3 Likert scale; total score 0-63).
Timepoint [1] 301432 0
Baseline, 8-weeks and 12-weeks after intervention commencement.
Secondary outcome [1] 332631 0


*The Five Facet Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). The FFMQ is a 39-item that assesses mindfulness on five scales (1-5 Likert scale; total score 39-195).

Timepoint [1] 332631 0
Baseline, 8-weeks and 12-weeks after intervention commencement.
Secondary outcome [2] 332881 0
* The Quality of Life Inventory (QOLI; Frisch, Cornell, Villanueva, & Retzlaff, 1992). The QOLI assesses the importance of (0-2) Likert scale) and satisfaction with (-3 to 3 Likert scale) 16 life domains on 32 items (total score -6 to 6);
Timepoint [2] 332881 0
Baseline, 8 weeks and 12 weeks
Secondary outcome [3] 332882 0
The Insomnia Severity Index (ISI; Morin, 1993). The ISI is a brief questionnaire that assesses insomnia on 7 items (0-4 Likert scale; total score 0-28);
Timepoint [3] 332882 0
Baseline, 8 weeks and 12 weeks

Eligibility
Key inclusion criteria
The participants must have an Anxiety Disorder, not have had a psychotic episode, not be experienced meditators and be able to understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The absence of an Anxiety 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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Whilst group 1 does the meditation they are also receiving treatment as usual in their outpatient group. Group 2 will only be receiving the treatment as usual in their outpatient group during the same time period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine the sample size required, an a priori power analysis was conducted using G*Power 3.1.9.2 This identified that to achieve a target power of .80 with p < .05, an anticipated medium effect size, and two predictor variables (time and meditation), a sample size of 86 would be required. However, as this is a pilot study, a smaller number of participants is anticipated.

To determine the participants’ anxiety levels, quality of life, trait mindfulness and sleep quality over the 8-week time period in both the treatment and control group, a 2 (participant type: control vs treatment) by 3 (time: pre, 8 weeks, 12 weeks) mixed design ANOVA will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7652 0
St John of God Hospital - Burwood
Recruitment postcode(s) [1] 15565 0
2134 - Burwood

Funding & Sponsors
Funding source category [1] 295943 0
University
Name [1] 295943 0
Australian Catholic University
Country [1] 295943 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
25A Barker St, Strathfield NSW 2135
Country
Australia
Secondary sponsor category [1] 294723 0
Hospital
Name [1] 294723 0
St John of God, Burwood
Address [1] 294723 0
13 Grantham St, Burwood, NSW 2134
Country [1] 294723 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297145 0
ACU Research Ethics Committee
Ethics committee address [1] 297145 0
Ethics committee country [1] 297145 0
Australia
Date submitted for ethics approval [1] 297145 0
25/09/2016
Approval date [1] 297145 0
27/02/2017
Ethics approval number [1] 297145 0
2016-306E

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1570 1570 0 0
/AnzctrAttachments/372516-ACU participant info letter with logos.pdf (Participant information/consent)
Attachments [2] 1571 1571 0 0
/AnzctrAttachments/372516-Memorandum of Agreement SJOG.pdf (Supplementary information)

Contacts
Principal investigator
Name 73122 0
Ms Ewa Geba
Address 73122 0
Mary Aikenhead Clinic
Australian Catholic University
163-167 Albert Rd, Strathfield, NSW 2135
Country 73122 0
Australia
Phone 73122 0
+61 2, 9701 4708
Fax 73122 0
-
Email 73122 0
ewa.geba@acu.edu.au
Contact person for public queries
Name 73123 0
Sally Blair
Address 73123 0
Mary Aikenhead Clinic
Australian Catholic University
163-167 Albert Rd, Strathfield, NSW 2135
Country 73123 0
Australia
Phone 73123 0
+61 2 9701 4708
Fax 73123 0
-
Email 73123 0
sally.blair@myacu.edu.au
Contact person for scientific queries
Name 73124 0
Ewa Geba
Address 73124 0
Mary Aikenhead Clinic
Australian Catholic University
163-167 Albert Rd, Strathfield, NSW 2135
Country 73124 0
Australia
Phone 73124 0
+61 2 9701 4708
Fax 73124 0
-
Email 73124 0
ewa.geba@acu.edu.au

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.