Healthy Lifestyle Promotion as Adjunctive Teletherapy for Treatment-resistant Major Depression
Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic: A Randomized Clinical Trial Protocol
1 other identifier
interventional
186
1 country
1
Brief Summary
The main objective of the study will be to evaluate the effectiveness of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be depression severity and secondary outcomes will include health-related quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2020
CompletedFirst Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2022
CompletedJune 11, 2020
June 1, 2020
2 years
June 9, 2020
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression severity
Beck Depression Inventory-II (BDI-II)
12 month
Secondary Outcomes (1)
Health-related quality of life
12 month
Study Arms (3)
Intervention
EXPERIMENTALLifestyle change promotion program
Control 1
ACTIVE COMPARATORMBCT program
Control 2
PLACEBO COMPARATORUsual care
Interventions
The intervention consists of 8 group sessions centered on healthy physical activity, healthy diet, social life, Good Sleep Hygiene, healthy sun exposure, nature contact, how to stop ruminating, review and maintenance tips.
The intervention consists of 8 group sessions with a mindfulness-based cognitive program
Written information about lifestyle change suggestions
Eligibility Criteria
You may qualify if:
- Individuals aged 18 or older.
- Diagnosis of Major Depressive Disorder as stated by the DSM-5.
- Two previous treatment failures (non-response to an adequate dose of potentially effective medication for an adequate length of time or treatment intolerance or refusal) in the current episode.
- At least one month of treatment with a psychiatrist and/or psychologist in the current episode.
- Physical and cognitive aptitudes to understand and give written informed consent.
You may not qualify if:
- Comorbidity with other medical conditions which would affect the Central Nervous System (CNS).
- Other severe psychiatric disorders (except for anxiety disorders or personality disorders)
- Other non-controlled severe medical diseases, infectious or degenerative which would interfere with affective symptomatology or the adherence to the hygienic-dietary recommendations.
- Patients with delusions or hallucinations which are congruent or non-congruent with mood.
- Patients with an important risk for suicide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitat Illes Balears
Palma de Mallorca, Balearic Islands, 07122, Spain
Related Publications (1)
Navarro C, Yanez AM, Garcia A, Segui A, Gazquez F, Marino JA, Ibarra O, Serrano-Ripoll MJ, Gomez-Juanes R, Bennasar-Veny M, Salva J, Olivan B, Roca M, Gili M, Garcia-Toro M. Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol. Medicine (Baltimore). 2020 Nov 6;99(45):e22958. doi: 10.1097/MD.0000000000022958.
PMID: 33157937DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 11, 2020
Study Start
January 13, 2020
Primary Completion
January 12, 2022
Study Completion
July 12, 2022
Last Updated
June 11, 2020
Record last verified: 2020-06