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

NCT04428099 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2020-06-11

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Treatment-Resistant

Interventions

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

Sponsors & Collaborators

  • University of the Balearic Islands

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2022-01-12
Completion
2022-07-12

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428099 on ClinicalTrials.gov