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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Behavioral: standard 8-weeks MBSR
* Behavioral: 4-week shortened MBSR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard 8-weeks MBSR<br>8-week program | Behavioral: standard 8-weeks MBSR<br>* 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).<br>|
| Experimental: 4-week shortened MBSR<br>Short 4 sessions intervention | Behavioral: 4-week shortened MBSR<br>* 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).<br>|
| No Intervention: Control Group<br>control group: No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) |  | baseline | 
| Hospital Anxiety and Depression Scale (HADS) change from baseline |  | post-treatment 8 weeks from baseline in 8 weeks intervention group | 
| Hospital Anxiety and Depression Scale (HADS) change from baseline |  | post-treatment 4 weeks from baseline in 4 weeks intervention group | 
| Hospital Anxiety and Depression Scale (HADS) change from baseline |  | six-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |