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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02643927
Other study ID # PI12/00134
Secondary ID
Status Completed
Phase Phase 0
First received December 18, 2015
Last updated December 31, 2015
Start date February 2013
Est. completion date October 2013

Study information

Verified date December 2015
Source Hospital Miguel Servet
Contact n/a
Is FDA regulated No
Health authority Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Study type Interventional

Clinical Trial Summary

The aim of this study was to assess and compare the efficacy of a standard 8-weeks protocol based on the Mindfulness Based Stress Reduction MBSR program versus a 4-week shortened version of the protocol in the improvement of wellbeing variables in a non-clinical population in Spain. The investigators initial hypothesis was that both protocols are efficacious but the standard 8-week performs better that the short one.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date October 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- be adult (18-y or older);

- willingness to participate in the study and signing informed consent;

- ability to understand and write Spanish.

Exclusion Criteria:

- have an acute clinical or psychiatry condition;

- have no previous experience with mindfulness or other type of contemplative or mind-boy practices such as yoga, taichi or chikung.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
standard 8-weeks MBSR
A 8 weekly sessions of 120 min based on the standard protocol of Kabat Zinn was performed. The adapted program did not include a one-day retreat in silence, but one session in silence plus extra kindly awareness (compassion-based) and value-based exercises. Home practice was not systematically assessed, but recommended to be of 45min per day, most of the days. It was administered by a trained (3-y experience) and certified MBSR teacher (MMPD).
4-week shortened MBSR
This protocol was made up of 4 sessions of 120 mn administered by the same trained MBSR programme therapist to avoid variables associated to the therapist. The rationale behind the shortened version of MBSR was to keep the core content and practices of the program, in fewer sessions: raisin exercise (experiential concept of mindfulness); and main anchors of attention (breathing, body sensations, body movements).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital Miguel Servet

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Anxiety and Depression Scale (HADS) baseline No
Primary Hospital Anxiety and Depression Scale (HADS) change from baseline post-treatment 8 weeks from baseline in 8 weeks intervention group No
Primary Hospital Anxiety and Depression Scale (HADS) change from baseline post-treatment 4 weeks from baseline in 4 weeks intervention group No
Primary Hospital Anxiety and Depression Scale (HADS) change from baseline six-months follow-up No
Secondary Mindful Attention Awareness Scale (MAAS) baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up No
Secondary Five Facets Mindfulness Questionnaire (FFMQ) baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up No
Secondary Self-Compassion Scale (SCS) baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up No
Secondary The Positive and Negative Affect Scale (PANAS) baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up No
Secondary Connor-Davidson Resilience Scale (10-item CD-RISC) baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up No
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