Healthy Lifestyle Promotion as Adjunctive Teletherapy for Treatment-resistant Major Depression
Primary Purpose
Depressive Disorder, Treatment-Resistant
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle change promotion program
Mindfullness based cognitive program
Written Information
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant focused on measuring heallthy Lifestyle, Minfullness based cognitive therapy, Teletherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Universitat Illes BalearsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Intervention
Control 1
Control 2
Arm Description
Lifestyle change promotion program
MBCT program
Usual care
Outcomes
Primary Outcome Measures
Depression severity
Beck Depression Inventory-II (BDI-II)
Secondary Outcome Measures
Health-related quality of life
Questionnaire (EQ-5D)
Full Information
NCT ID
NCT04428099
First Posted
June 9, 2020
Last Updated
June 10, 2020
Sponsor
University of the Balearic Islands
1. Study Identification
Unique Protocol Identification Number
NCT04428099
Brief Title
Healthy Lifestyle Promotion as Adjunctive Teletherapy for Treatment-resistant Major Depression
Official Title
Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic: A Randomized Clinical Trial Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
January 12, 2022 (Anticipated)
Study Completion Date
July 12, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Balearic Islands
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Depression is a very prevalent, incapacitating illness. The treatment available (psychotherapy and drug therapy) do not always manage to achieve complete remission of the symptoms or prevent its relapses or recurrences. For that reason, it is still necessary to investigate new adjuvant therapeutic antidepressant alternatives, especially if they can add efficacy to the treatment without reducing tolerance and safety. In the last few years, data have been growing about the usefulness of having patients who are depressed make specific changes in their lifestyles.
The main objective of the study will be to evaluate the effectiveness and efficiency 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 MBCT program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. Two control groups were designed: placebo-control (written lifestyle change suggestion) and active-control (MBCT). We selected this adjuvant therapy because MBCT has shown positive results as an adjunctive treatment for resistant depression in previous studies and it could be administered in a similar format as our intervention (8-weeks lifestyle change promotion program). We hypothesize that the lifestyle change promotion program at 12 months of follow-up will be more effective because patients will have better adherence to this intervention than to MBCT.
This study will be carried out during the COVID-19 pandemic, therefore the administration of the intervention will be administered by teletherapy. Different ways and technologies will be used to contact participants remotely: telephone calls, text messages, WhatsApp groups, and teleconferences.
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 measured using the Beck Depression Inventory-II (BDI-II). Secondary outcomes will include Clinical Global Impressions (CGI) Scale, to quantify and track patient progress and treatment response over time and Health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Treatment-Resistant
Keywords
heallthy Lifestyle, Minfullness based cognitive therapy, Teletherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lifestyle change promotion program
Arm Title
Control 1
Arm Type
Active Comparator
Arm Description
MBCT program
Arm Title
Control 2
Arm Type
Placebo Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle change promotion program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfullness based cognitive program
Intervention Description
The intervention consists of 8 group sessions with a mindfulness-based cognitive program
Intervention Type
Behavioral
Intervention Name(s)
Written Information
Intervention Description
Written information about lifestyle change suggestions
Primary Outcome Measure Information:
Title
Depression severity
Description
Beck Depression Inventory-II (BDI-II)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
Questionnaire (EQ-5D)
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro García-Toro, PhD
Phone
+34 971 259966
Email
mauro.garcia@uib.es
Facility Information:
Facility Name
Universitat Illes Balears
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07122
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro García-Toro, PhD
Phone
971 259966
Email
mauro.garcia@uib.es
12. IPD Sharing Statement
Citations:
PubMed Identifier
33157937
Citation
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.
Results Reference
derived
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Healthy Lifestyle Promotion as Adjunctive Teletherapy for Treatment-resistant Major Depression
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