NCT04058119

Brief Summary

Mental disorders are among the most common causes of disability globally. Given the high prevalence of mental disorders (57.0%) in Azores islands (Portugal), local primary health care (PHC) services should encourage the implementation of complementary interventions for prevention of this type of disorders. New approaches, such as mind-body therapies, have been studied and recommended for prevention and treatment of numerous chronic diseases, particularly mental disorders. This study aims to evaluate the feasibility and effectiveness of a 6-months mind-body therapies (yoga, qigong and pilates), in users of Ponta Delgada Health Center (PDHC) with perceived distress, compared to a waiting list control.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

Same day

First QC Date

August 8, 2019

Last Update Submit

October 25, 2019

Conditions

Psychological Stress

Keywords

Mind-body therapiesYogaQigongPilatesPrimary health care

Outcome Measures

Primary Outcomes (1)

  • Change in perceived stress

    Perceived Stress Scale (PSS 10), validated for portuguese population, is a self-report scale with 10 items on daily hassles and the current feeling of being able to handle problems that need to be addressed. It is a five-point Likert scale ranging from 0 (never) to 4 (very often). This questionnaire is widely used to measure perceived stress and has adequate internal and test-retest reliability.

    T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)

Secondary Outcomes (19)

  • Adherence to the mind-body sessions

    Up to 6 months

  • Perceived enjoyment

    Up to 6 months

  • Perceived exertion

    Up to 6 months

  • Participants' satisfaction

    T1, Post-intervention (at month 6)

  • Change in hand grip strength

    T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)

  • +14 more secondary outcomes

Study Arms (2)

Mind-body therapies

EXPERIMENTAL

Sessions of body-mind therapies (yoga, qigong and pilates)

Behavioral: Mind-body therapies

Waiting list control group

NO INTERVENTION

Participants will not participate in any specific intervention, but will receive the Functional Training Program after the experimental period (6 months).

Interventions

Mind-body therapiesBEHAVIORAL

Sessions of body-mind therapies (yoga, qigong and pilates), oriented by certified instructors. Every sessions will be 60-minutes long, biweekly, with a total duration of 6 months.

Mind-body therapies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Users of Ponta Delgada Health Center with perceived distress (score higher than 20 for men and higher than 22 for women in PSS-10).

You may not qualify if:

  • Users with recent practice (less than 3 months) of any mind-body therapies;
  • Users with medical contraindications to moderate-to-vigorous intensity physical activities, such as: unstable angina; deep vein thrombosis; recent thromboembolism or embolism; acute systemic infection or fever; atrioventricular block of 2nd grade or higher (without pacemaker); negative deflection of the ST segment deflection of the ST segment \> 2 mm; severe neuro-musculoskeletal dysfunction; severe mitral or aortic insufficiency or stenosis without adequate treatment; decompensated heart failure; resting heart rate above 100 bpm; other decompensated metabolic disorders; pericarditis or acute myocarditis; uncontrolled arrhythmia; uncontrolled resting hypertension (SBP ≥ 180 or DBP ≥ 110); orthostatic hypotension with a fall in SBP\> 20 mmHg or uncontrolled diabetes;
  • Users with physical and/or mental disabilities;
  • Users with severe psychiatric diagnosis or/and active psychosis or
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)

Ponta Delgada, Azores, 9500-354, Portugal

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Sara B. Ponte, MD

    Unidade de Saúde da Ilha de São Miguel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara B. Ponte, MD

CONTACT

+351 296 960 286Sara.CB.Ponte@azores.gov.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, General Practitioner

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 15, 2019

Study Start

February 1, 2020

Primary Completion

February 1, 2020

Study Completion

December 1, 2021

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

PT(1)