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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Behavioral: standard 8-weeks MBSR; Behavioral: 4-week shortened MBSR

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard 8-weeks MBSR; 8-week program	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).
Experimental: 4-week shortened MBSR; Short 4 sessions intervention	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).
No Intervention: Control Group; control group: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 31, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: PI12/00134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided