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Completed

NCT Number: NCT02643927

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard 8-weeks MBSR

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

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).

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline

  2. Hospital Anxiety and Depression Scale (HADS) change from baseline

    Time frame: post-treatment 8 weeks from baseline in 8 weeks intervention group

  3. Hospital Anxiety and Depression Scale (HADS) change from baseline

    Time frame: post-treatment 4 weeks from baseline in 4 weeks intervention group

  4. Hospital Anxiety and Depression Scale (HADS) change from baseline

    Time frame: six-months follow-up

Secondary outcomes

  1. Mindful Attention Awareness Scale (MAAS)

    Time frame: 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

  2. Five Facets Mindfulness Questionnaire (FFMQ)

    Time frame: 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

  3. Self-Compassion Scale (SCS)

    Time frame: 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

  4. The Positive and Negative Affect Scale (PANAS)

    Time frame: 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

  5. Connor-Davidson Resilience Scale (10-item CD-RISC)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 31, 2015
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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