Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population

Healthy Subjects Clinical Trial

Official title:

Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population: a Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643927
• Other study ID #: PI12/00134
• 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

• Healthy Subjects

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