ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

None

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety disorders

Depressive disorders

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

Pre-intervention/baseline
Post-intervention (8 weeks) (Primary timepoint)
Three-months post-intervention
12-months post-intervention

Secondary outcome [1]

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]