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Trial registered on ANZCTR


Registration number
ACTRN12620000601932
Ethics application status
Approved
Date submitted
28/04/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining yoga as a complementary therapy for anxiety and depression
Scientific title
Examining yoga as an adjunct treatment to CBT for adults with anxiety and depression
Secondary ID [1] 295370 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 308603 0
Depressive disorders 308604 0
Condition category
Condition code
Mental Health 307550 307550 0 0
Anxiety
Mental Health 307551 307551 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As a pragmatic trial, all participants have the option to self-select into an eight week, yoga therapy program in addition to treatment as usual (control condition) consisting of 8 weekly group yoga sessions of 60 minutes each and a personalised home practice. The yoga practice includes:
- Gentle asana (physical postures) suitable for all levels of experience and utilising suitable modifications where necessary. Postures may be standing, lying or sitting.
- Breath awareness and implementation of pranayama techniques. The main technique taught and utilised during the 8 weeks will be ujjayi breathing (observation of breath drawing softly through back of nose and throat space during inhalation and exhalation) with a focus on extending breath length.
- Relaxation with a movement towards meditative focus. The goal at the end of each class will be to give participants a deep experience of relaxation and a direction towards focusing the mind.

The personalised practice will be developed by the Yoga Teacher based on the participants needs and abilities. It will consist of 15-30 minutes of breath-based movement and relaxation, encouraged to practice at home practice each day (at least three days per week).

Participant attendance to group classes will be recorded by the yoga teacher and they will complete weekly practice logs regarding the frequency and their experiences of the home practice.
Intervention code [1] 301693 0
Treatment: Other
Intervention code [2] 317550 0
Lifestyle
Comparator / control treatment
All participants will attend a two-hour group therapy session session once a week for eight weeks as per their usual treatment. The program draws on the manualised CBT Mood-Management Course protocol, adapted from the Centre of Clinical Interventions (Nathan et al., 2004). It is designed to provide effective treatment for individuals experiencing anxiety and depression in a group setting that is comparable in efficacy to individual CBT (Craigie & Nathan, 2009). The program aims to assist individuals to:
- Gain an understanding of depression and anxiety,
- Learn practical strategies for managing them,
- Practice the techniques both in and outside of the group setting, and
- Learn how to maintain the gains they have made during therapy and prevent relapse.

The program is conducted at the clinic by a Clinical Psychologist and up to three Provisional Psychologists. It typically consists of 10 participants per group, and includes the following concepts:
- Education about depression and anxiety,
- Identifying activities that give a sense of pleasure or achievement, and working to include these in regular routines,
- Learning to break down overwhelming tasks into manageable steps,
- Learning a breathing technique to manage physical symptoms of anxiety,
- Cognitive therapy (identifying, questioning and changing unhelpful thoughts), and
- Learning how to actively cope with problems.
Control group
Active

Outcomes
Primary outcome [1] 306529 0
Clinically significant change will be assessed based on the totals scores of the Depression Anxiety Stress Scale - 21 items (DASS-21)* (Lovibond & Lovibond, 1995). The DASS-21 is a self-report measure that consists of three scales designed to assess the emotional states of depression, anxiety and stress. Each of the three scales contains seven items that are scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores are calculated for each subscale, with the total score calculated by summing each subscale multiplied by two. The scale is reported to have high internal consistency (Cronbach’s alpha = .92) and re-test reliability (r = .91) (Lovibond & Lovibond, 1995).
Timepoint [1] 306529 0
Pre-intervention/baseline
Post-intervention (8 weeks) (Primary timepoint)
Three-months post-intervention
12-months post-intervention
Secondary outcome [1] 348793 0
The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)* will also be in the battery of measures (Feldman et al., 2007). The CAMS-R is a self-report measure that involves 10 statements phrased in everyday language that reflect the four first order factors of mindfulness: attention, present-focus, awareness, and acceptance. Respondents rate their agreement with the statements from 1 (rarely/not at all) to 4 (almost always), where higher scores reflect greater mindful qualities overall. The CAMS-R has demonstrated acceptable internal consistency and evidence of convergent and discriminant validity with concurrent measures of mindfulness, distress, well-being, emotion-regulation and problem solving (Feldman et al., 2007).
Timepoint [1] 348793 0
Pre-intervention/baseline
Post-intervention (8 weeks)
Three-months post-intervention
12-months post-intervention
Secondary outcome [2] 382816 0
The Outcome Rating Scale (ORS) is a brief visual analogue self-report measure of individual functioning (Miller, Brown, Sparks & Claud, 2003). The ORS assesses how individuals are feeling across four areas of functioning: individually, interpersonally, socially and overall. Scores for each domain range from 0-10, and are totalled to an overall score out of 40. Scores below 25 indicate symptoms of clinical significance. The scale demonstrates good psychometric properties and is sensitive to change in treatment-seeking populations (Miller et al., 2003).
Timepoint [2] 382816 0
Pre-intervention/baseline
Post-intervention (8 weeks)
Three-months post-intervention
12-months post-intervention
Secondary outcome [3] 382817 0
The Mental Health Recovery Star is a self-report outcome measure which invites individuals to measure their own recovery progress across ten aspects of life, including: living skills, relationships, work and identity, and self-esteem (MacKeith & Burns, 2008). Each domain is rated alongside the “Ladder of Change”, from 1-10, where scores of 10 indicates full recovery. The Mental Health Recovery Star has been found a valid and useful tool in the Australian mental health service sector (Lloyd, Williams, Machingura & Tse, 2015).
Timepoint [3] 382817 0
Pre-intervention/baseline
Post-intervention (8 weeks)
Three-months post-intervention
12-months post-intervention
Secondary outcome [4] 382818 0
The Beck Depression Inventory II (BDI-II)* is one of the widely accepted instruments for measuring depression in adults. It is a 21-item scale arising from clinical observations. Recent additions include items relating to agitation, worthlessness, concentration difficulty and loss of energy. Scores range from 0-63, with a suggested cut-off score of 17 or higher indicating the presence of clinical depression (Beck, Steer & Brown, 2000).
Timepoint [4] 382818 0
Pre-intervention/baseline
Post-intervention (8 weeks)
Three-months post-intervention
12-months post-intervention
Secondary outcome [5] 382819 0
Assessment of Quality of Life (AQoL 8D)* is a patient self-report instrument that aims to assess of quality of life and provides opportunity to assess health economic metrics (Maxwell, Özmen, Iezzi & Richardson, 2016). The AQoL-8D consists of 35 items, which examine quality of life across the following domains: Independent Living, Happiness, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses. It takes approximately 5 minutes to complete. Scores on each item are added together to provide an overall profile for health related quality of life, as well as for each dimension. The AQoL-8D was developed and validated in Australia with a large sample of adults, aged 16-74 (Maxwell et al., 2016).
Timepoint [5] 382819 0
Pre-intervention/baseline
Post-intervention (8 weeks)
Three-months post-intervention
12-months post-intervention
Secondary outcome [6] 382820 0
The Patient Global Impressions Scale (PGI)* is a self-report, single item measure that aims to evaluate patients' perceptions of their health and assesses if there has been an improvement or decline in clinical status (Guy, 1976). The participant has to select the one response from the response options that gives the most accurate description of his/her state of health (overall status). The scale is widely validated for use measuring treatment for chronic pain (e.g. Farrar, Young, La Moreaux, Werth & Poole, 2001), and the manual indicates that it can be applied across a range of conditions (Guy, 1976).
Timepoint [6] 382820 0
Post-intervention (8 weeks)
Three-months post-intervention
12-months post-intervention

Eligibility
Key inclusion criteria
- Diagnosis of anxiety or depression of mild to moderate severity, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), established via Clinical Interview based on the Structured Clinical Interview (SCID) for DSM-5 (American Psychological Association (APA), 2013).
- English speaking.
- Capacity to provide informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Based on the clinic exclusion criteria for participating in a group program, individuals will not be eligible to participate in the trial if they are:
- Deemed to have a high risk of harming self or others.
- Deemed unsuitable for group treatment at the time (e.g. presentation is too complex, or individual may not benefit due to personality style etc.). Screening procedures used by the clinic identify such individuals.
- Not available to participate in the group programs at the allocated times.
- Experiencing a significant medical comorbidity, cognitive impairment, or substance dependence.

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



Intervention assignment
Other
Other design features
Self-selection
Long-term follow up at 3 and 12 month time points
Mixed-methods
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be entered into SPSS, and the study hypotheses will be tested with the linear mixed effects models to compensate for expected attrition over time. In these models, the dependent variable is the DASS-21, with predictors being Time, Group and the Interaction between Time and Group - the coefficient for Interaction being the formal test of the hypothesis. The alpha level for all analyses will be set at .05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/10/2018
Date of last participant enrolment
Anticipated
Actual
23/03/2020
Date of last data collection
Anticipated
23/03/2021
Actual
Sample size
Target
60
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299956 0
University
Name [1] 299956 0
Deakin University
Country [1] 299956 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
School of Psychology
1 Gheringhap Street
Geelong
VIC 3220
Country
Australia
Secondary sponsor category [1] 299335 0
Other Collaborative groups
Name [1] 299335 0
Barwon Health Deakin Psychology Clinic
Address [1] 299335 0
Level 1
131 Myers Street
Geelong
VIC 3220
Country [1] 299335 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300819 0
Barwon Health Human Research Ethics Committee (BH HREC)
Ethics committee address [1] 300819 0
University Hospital Geelong
Corner Bellerine and Ryrie Street
Geelong
VIC 3220
Ethics committee country [1] 300819 0
Australia
Date submitted for ethics approval [1] 300819 0
27/06/2018
Approval date [1] 300819 0
11/07/2018
Ethics approval number [1] 300819 0
18/102

Summary
Brief summary
This is a pragmatic, proof-of-concept study which aims to explore yoga as an adjunct treatments to cognitive behavioural therapy (CBT) for adults with anxiety and depression. Up to 60 participants will be recruited from an existing eight week group CBT program for treatment of anxiety or depression at a primary mental health clinic and invited to take part in a tailored yoga program in addition to their usual treatment, consisting of weekly group classes and an individualised home practice. Mixed-methods data will be collected at pre post and follow up time points. It is expected that individualised who complete yoga in addition to CBT will experience significantly greater reduction in clinical symptoms compared to those engaged in CBT alone. Furthermore, it is expected that qualitative findings will provide insights into whether yoga is an acceptable adjunct treatment to CBT, if adults with anxiety and depression experience yoga as complementary and how.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84918 0
A/Prof Melissa O'Shea
Address 84918 0
Deakin University
School of Psychology
1 Geringhap St
Geelong
VIC 3220
Country 84918 0
Australia
Phone 84918 0
+61 03 5247 9486
Fax 84918 0
Email 84918 0
[email protected]
Contact person for public queries
Name 84919 0
Melissa O'Shea
Address 84919 0
Deakin University
School of Psychology
1 Geringhap St
Geelong
VIC 3220
Country 84919 0
Australia
Phone 84919 0
+61 04 5247 9486
Fax 84919 0
Email 84919 0
[email protected]
Contact person for scientific queries
Name 84920 0
Melissa O'Shea
Address 84920 0
Deakin University
School of Psychology
1 Geringhap St
Geelong
VIC 3220
Country 84920 0
Australia
Phone 84920 0
+61 03 5247 9486
Fax 84920 0
Email 84920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality and privacy as detailed in ethics approval


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
SourceTitleYear of PublicationDOI
EmbaseA pragmatic preference trial of therapeutic yoga as an adjunct to group cognitive behaviour therapy versus group CBT alone for depression and anxiety.2022https://dx.doi.org/10.1016/j.jad.2022.03.028
N.B. These documents automatically identified may not have been verified by the study sponsor.