Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Healthy Lifestyle Promotion as Adjunctive Teletherapy for Treatment-resistant Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428099
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of the Balearic Islands

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Treatment-Resistant Behavioral: Lifestyle change promotion program Behavioral: Mindfullness based cognitive program Behavioral: Written Information Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : January 12, 2022
Estimated Study Completion Date : July 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: Intervention
Lifestyle change promotion program
Behavioral: Lifestyle change promotion program
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.

Behavioral: Written Information
Written information about lifestyle change suggestions

Active Comparator: Control 1
MBCT program
Behavioral: Mindfullness based cognitive program
The intervention consists of 8 group sessions with a mindfulness-based cognitive program

Behavioral: Written Information
Written information about lifestyle change suggestions

Placebo Comparator: Control 2
Usual care
Behavioral: Written Information
Written information about lifestyle change suggestions




Primary Outcome Measures :
  1. Depression severity [ Time Frame: 12 month ]
    Beck Depression Inventory-II (BDI-II)


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 12 month ]
    Questionnaire (EQ-5D)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428099


Contacts
Layout table for location contacts
Contact: Mauro García-Toro, PhD +34 971 259966 mauro.garcia@uib.es

Locations
Layout table for location information
Spain
Universitat Illes Balears Recruiting
Palma de Mallorca, Illes Balears, Spain, 07122
Contact: Mauro García-Toro, PhD    971 259966    mauro.garcia@uib.es   
Sponsors and Collaborators
University of the Balearic Islands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of the Balearic Islands
ClinicalTrials.gov Identifier: NCT04428099    
Other Study ID Numbers: RMD01
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of the Balearic Islands:
heallthy Lifestyle
Minfullness based cognitive therapy
Teletherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders