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

NCT02643927 | Completed Early Phase 1

• 1 other identifier: PI12/00134
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (3)

standard 8-weeks MBSR

EXPERIMENTAL

8-week program

Behavioral: standard 8-weeks MBSR

4-week shortened MBSR

EXPERIMENTAL

Short 4 sessions intervention

Behavioral: 4-week shortened MBSR

Control Group

NO INTERVENTION

control group: No intervention

Interventions

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).

standard 8-weeks MBSR

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).

4-week shortened MBSR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be adult (18-y or older);
• willingness to participate in the study and signing informed consent;
• ability to understand and write Spanish.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Miguel Servet: lead

Related Publications (1)

• 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.

  PMID: 28848465 DERIVED

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 31, 2015
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 1, 2016

Record last verified: 2015-12