Clinical trial NCT02643927: Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population
Official title: Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population: a Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Subjects
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS) change from baseline
timeFrame: post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Hospital Anxiety and Depression Scale (HADS) change from baseline
timeFrame: post-treatment 4 weeks from baseline in 4 weeks intervention group
measure: Hospital Anxiety and Depression Scale (HADS) change from baseline
timeFrame: six-months follow-up
Secondary outcomes:
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: 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
measure: Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: 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
measure: Self-Compassion Scale (SCS)
timeFrame: 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
measure: The Positive and Negative Affect Scale (PANAS)
timeFrame: 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
measure: Connor-Davidson Resilience Scale (10-item CD-RISC)
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References:
citation: 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.