NCT04428099

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: University of the Balearic Islands · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2020-01-13
• Primary completion: 2022-01-12
• Completion: 2022-07-12
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

1 site across 1 country: Spain