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

NCT ID: NCT02643927

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-10-31

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.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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standard 8-weeks MBSR

8-week program

Group Type EXPERIMENTAL

standard 8-weeks MBSR

Intervention Type BEHAVIORAL

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

Short 4 sessions intervention

Group Type EXPERIMENTAL

4-week shortened MBSR

Intervention Type BEHAVIORAL

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).

Control Group

control group: No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Miguel Servet

OTHER

Sponsor Role lead

Responsible Party

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Javier Garcia Campayo

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Demarzo M, Montero-Marin J, Puebla-Guedea M, Navarro-Gil M, Herrera-Mercadal P, Moreno-Gonzalez S, Calvo-Carrion S, Bafaluy-Franch L, Garcia-Campayo J. Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study. Front Psychol. 2017 Aug 8;8:1343. doi: 10.3389/fpsyg.2017.01343. eCollection 2017.

Reference Type DERIVED
PMID: 28848465 (View on PubMed)

Other Identifiers

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PI12/00134

Identifier Type: -

Identifier Source: org_study_id

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