Condition category
Mental and Behavioural Disorders
Date applied
18/09/2019
Date assigned
27/09/2019
Last edited
27/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Patients with chronic mood and anxiety disorders experience many life stressors and are more reactive to these stressors. Mindful yoga represents an intervention that might reduce stress reactivity. However, little is known about affect regulation strategies by which yoga might reduce stress reactivity. In this study, we examined within-person temporal associations between stressful experiences, affect and four potential affect regulation strategies: rumination, fear of emotions, mindfulness and body awareness, before and after a yoga intervention. Using experience sampling methodology, 12 patients with chronic mood and anxiety disorders completed five daily assessments for 15 days before and after a 9-week mindful yoga intervention. Autoregressive moving average models were used to assess mean-level change from pre to post intervention and vector autoregressive models to assess change in the temporal associations. Most individuals experienced positive changes in affect and the proposed affect regulation strategies. There were individual differences in which pathways from stress to the strategies and from the strategies to affect changed and how they changed. In the context of daily life stress, change seems to be more difficult and complex, and it remains difficult for many individuals to preserve a better affect balance with regards to the proposed affect regulation strategies.

Background and study aims
Patients with chronic (long-standing) mood and anxiety disorders experience many stressful situations in the life such as suicide attempts and hospitalizations, higher risk of developing physical illnesses and problems with physical, social and work functioning. Moreover, they also react more strongly to these stressors. Mindful yoga could be a technique to reduce stress reactivity. However, little is known about the processes by which mindful yoga might reduce stress reactivity. Rumination (repeatedly thinking about problems) and fear of emotions are two processes that might increase stress reactivity, and mindfulness and body awareness (understanding of the body's position and sensations) are two processes that might reduce stress reactivity. This study aims to investigate changes within people from before to after a 9-week mindful yoga course. It will examine the relationships between stressful experiences, moods and feelings, and four ways of changing moods and feelings: rumination, fear of emotions, mindfulness, and body awareness.

Who can participate?
Adults with a chronic mood or anxiety disorder who are currently in treatment at a mental health clinic.

What does the study involve?
All participants receive a 9-week mindful yoga intervention. Before and after the intervention they completed five daily assessments over 15 days. These daily assessments involved questions about the stressful events during their day, current mood/feelings, and questions on rumination, fear of emotions, mindfulness, and body
awareness. Before and after the yoga treatment, and at 6 and 12 months after the end of the yoga treatment, they also completed several questionnaires to assess
psychological symptoms, and quality of life.

What are the possible benefits and risks of participating?
Participants may potentially benefit from receiving the 9-week mindful yoga intervention. Mindful yoga, especially unsupervised practice, may lead to injuries. The participants were medically screened to see if they needed any adaptations of yoga postures because of certain health conditions. Also, the intervention was designed to be safe and
well-supervised in order to reduce the risk of injuries for the participants.

Where is the study run from?
The Center for Integrative Psychiatry, an outpatient department of Lentis Psychiatric Institute (Netherlands)

When is the study starting and how long is it expected to run for?
May 2015 to May 2017

Who is funding the study?
The Center for Integrative Psychiatry, an outpatient department of Lentis Psychiatric Institute (Netherlands)

Who is the main contact?
Nina Vollbehr, n.vollbehr@lentis.nl

Trial website

Contact information

Type

Public

Primary contact

Miss Nina Vollbehr

ORCID ID

http://orcid.org/0000-0002-7221-2585

Contact details

Hereweg 76
Groningen
9725AG
Netherlands
+31505223135
n.vollbehr@lentis.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2015/387

Study information

Scientific title

The temporal dynamics of daily life stress, affect, and several affect regulation strategies, in patients with (chronic) mood and anxiety disorders before and after a yoga intervention

Acronym

Study hypothesis

We hypothesized that after the yoga intervention, participants would show improved affect, and changes in the proposed affect regulation strategies, including reduced rumination and fear of emotions and greater mindfulness and body awareness. We also hypothesized that the temporal associations between the variables would change in beneficial directions (e.g., weakening of the positive association between stressful experiences and rumination). Finally, we hypothesized that we would find different individual pathways of change in the relationships between stress and the proposed affect regulation strategies; and in the relationships between these affect regulation strategies and affect.

Ethics approval

The Medical Ethical Committee of the University Medical Center Groningen judged the study protocol to be exempted from review by the Medical Research Involving Human Subjects Act (in Dutch: WMO) because it concerned a non-randomized open study (registration number 2015/387).

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Chronic mood and anxiety disorders

Intervention

Participants undertook a manualized 9-week mindful yoga intervention, based on traditional yogic practices and texts, which were adapted to a clinical setting for patients with mood and anxiety disorders, that was tested in a pilot study (Vollbehr, Hoenders, Bartels-Velthuis & Ostafin, 2019). The intervention consisted of weekly 90-minute sessions with yoga postures (80%), meditative practices and breathing techniques (20%). Participants received a manual with weekly registration forms and practice videos. When necessary, adaptations of postures were given (e.g., no full standing forward bend for a participant with high blood pressure). Material needed to adjust yoga postures was available for the participants.

We examined within-person temporal associations between stressful experiences, affect and four potential affect regulation strategies: rumination, fear of emotions, mindfulness and body awareness, before and after a yoga intervention, using experience sampling methodology.

Participants completed daily diary questionnaires on their smartphones. If they did not have a smartphone we gave them one including explanation of the functions to complete the questionnaires. Participants received a text message with a link to RoQua (www.roqua.nl), a secure online survey administration program, to complete on their smartphone. After 30 minutes, the participants were sent a reminder text message to complete the questionnaire, if they had not yet done so. If participants did not complete the questionnaires within 60 min, the questionnaire became inaccessible

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Affect balance assessed by deducting the positive affect items from the negative affect items in the Depression, Anxiety 2. Rumination assessed at pre- and post-intervention using one item from the Preservative Thinking Questionnaire (Ehring et al., 2011), ), adapted to reflect the focus on negative thoughts: “Many negative thoughts are going through my head”
2. Fear of emotions assessed at pre- and post-intervention using one item focusing on the fear of losing control of once emotions (Williams et al., 1997): “I feel overwhelmed with my emotions”, and one item focusing on the accepting, open awareness of emotions that is an aspect of mindfulness (Bishop et al., 2004): “I accept the way I am feeling”
3. Mindfulness assessed at pre- and post-intervention using items from the Mindful Attention and Awareness Scale (MAAS) with a high factor loading (Osman, Lamis, Bagge, Freedenthal & Barnes, 2016): “Over the last period I did tasks and errands automatically, without being aware of what I was doing” and “Over the last period I was living in the moment”. We reformulated the scoring of the second item, with a higher score indicating more mindfulness.
4. Body awareness assessed at pre- and post-intervention using two items, with the first reflecting the noticing of inner sensations (Mehling et al., 2012): “Over the last period I was aware of things that were happening in my body, for example tension, emotional responses or other sensations”. The other item focused on embodiment (Mehling et al., 2012): “Over the last period I felt at home in my body”.
5. Temporal associations between stress, rumination, fear of emotions, mindfulness and body awareness and affect balance assessed at pre- and post-intervention

Secondary outcome measures

N/A

Overall trial start date

01/05/2015

Overall trial end date

01/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Has a mood or anxiety disorder or post-traumatic stress disorder with an illness duration of at least 2 years
2. Receiving current treatment as usual
3. Willing to attend nine weekly sessions of a yoga intervention
4. Able to read and write Dutch
5. Aged over 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Acute suicidal symptoms
2. Acute psychotic symptoms
3. Substance abuse

Recruitment start date

01/10/2015

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Center for Integrative Psychiatry, Lentis Psychiatric Institute
Hereweg 76
Groningen
9725AG
Netherlands

Sponsor information

Organisation

Lentis Center for Integrated Psychiatry

Sponsor details

Hereweg 76
Groningen
9725AG
Netherlands
+31505223135
hjr.hoenders@lentis.nl

Sponsor type

Hospital/treatment centre

Website

http://www.lentis.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Lentis

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Nina Vollbehr, n.vollbehr@lentis.nl. Excel data files will be available from 01/10/2019 until 01/10/2029. Consent was obtained from the participants.

Intention to publish date

01/01/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/09/2019: Trial's existence confirmed by Lentis Research.