Anxiety Depression (Mild or Not Persistent)NCT02774018
Life Satisfaction and Psychopathology in Institutionalized Elderly People
A study testing Mindfulness-Based Stress Reduction (MBSR) program in people with Anxiety Depression (Mild or Not Persistent), run by Irmandade da Misericórdia de Albergaria-a-Velha.
Trial summary
The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life satisfaction and reduce psychopathology. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression (Mild or Not Persistent)
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- literacy
- age above 65 years
Who cannot join
- presence of cognitive or sensorial
- impairment
About this study
Official title: Life Satisfaction and Psychopathology in Institutionalized Elderly People: The Results of an Adapted Mindfulness-Based Stress Reduction Program
The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several selfreport questionnaires and were assessed with Mini Mental State Examination. Participants attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48 sessions (16 weeks) and Participants were evaluated before and after the intervention.
- Being tested
- Mindfulness-Based Stress Reduction (MBSR) program
- Keywords
- Mindfulness, Elderly, Psychopathology
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR) programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 12 institutionalized elderly people | Experimental | Mindfulness-Based Stress Reduction program. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression levels assessed with the GDS
GDS; Geriatric Depression Scale; Greenberg et al., 2005
Measured: Pre-test and Post-test (4 months later)
Change in anxiety levels assessed with the DASS-21
DASS-21; Depression Anxiety Stress Scale; Lovibond e Lovibond, 1995
Measured: Pre-test and Post-test (4 months later)
Change in experiential avoidance levels assessed with the AAQ-II
AAQ-II; Acceptance and Action Questionnaire; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz e Zettle, 2011
Measured: Pre-test and Post-test (4 months later)
Change in subjective pain levels assessed with the Faces Scale
Faces Scale; Wong et al., 2001
Measured: Pre-test and Post-test (4 months later)
Change in life satisfaction levels assessed with the SWLS
SWLS; Satisfaction with Life Scale; Diener et al., 1985
Measured: Pre-test and Post-test (4 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Depression (Mild or Not Persistent)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irmandade da Misericórdia de Albergaria-a-Velha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Seabra, Irmandade da Misericórdia de Albergaria-a-Velha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774018
- Sponsor's protocol ID
- 01_PSI_MINDFULNESS
- Status last verified
- May 2016
- First submitted
- 18 Apr 2016
- Last updated
- 16 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Satisfaction and Psychopathology in Institutionalized Elderly People: The Results of an Adapted Mindfulness-Based Stress Reduction Program
- ClinicalTrials.gov ID
- NCT02774018
- Acronym / sponsor ID
- 01_PSI_MINDFULNESS
- Keywords
- Mindfulness, Elderly, Psychopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Irmandade da Misericórdia de Albergaria-a-VelhaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several selfreport questionnaires and were assessed with Mini Mental State Examination. Participants attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48 sessions (16 weeks) and Participants were evaluated before and after the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12 institutionalized elderly people | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR) programMindfulness-Based Stress Reduction program. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- literacy
- age above 65 years
Key exclusion criteria (2 listed)
- presence of cognitive or sensorial
- impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) program | Behavioural | 12 institutionalized elderly people |
Primary outcome
Change in depression levels assessed with the GDS
Time frame: Pre-test and Post-test (4 months later)
GDS; Geriatric Depression Scale; Greenberg et al., 2005
Change in anxiety levels assessed with the DASS-21
Time frame: Pre-test and Post-test (4 months later)
DASS-21; Depression Anxiety Stress Scale; Lovibond e Lovibond, 1995
Change in experiential avoidance levels assessed with the AAQ-II
Time frame: Pre-test and Post-test (4 months later)
AAQ-II; Acceptance and Action Questionnaire; Bond, Hayes, Baer, Carpenter, Guenole, Orcutt, Waltz e Zettle, 2011
Change in subjective pain levels assessed with the Faces Scale
Time frame: Pre-test and Post-test (4 months later)
Faces Scale; Wong et al., 2001
Change in life satisfaction levels assessed with the SWLS
Time frame: Pre-test and Post-test (4 months later)
SWLS; Satisfaction with Life Scale; Diener et al., 1985
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) program in people with Anxiety Depression (Mild or Not Persistent), run by Irmandade da Misericórdia de Albergaria-a-Velha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression levels assessed with the GDS (time frame: Pre-test and Post-test (4 months later)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.