Evidence map›Paper›PMID 33157937›Full record

ArticleMedicine2020

Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol.

Capilla Navarro, Aina M Yáñez, Aurora Garcia, Andrea Seguí, Francisco Gazquez, Jose Antonio Marino, Olga Ibarra, Maria J Serrano-Ripoll, Rocio Gomez-Juanes, Miquel Bennasar-Veny and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04428099 (Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04428099 naunknown statusnot on this map

Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic: A Randomized Clinical Trial Protocol

TypeinterventionalSponsorUniversity of the Balearic IslandsRan2020 to 2022Enrolled186ConditionsDepressive Disorder, Treatment-ResistantArmsLifestyle change promotion program, Mindfullness based cognitive program, Written Information
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

Capilla NavarroResearch Institute of Health Sciences (IUNICS-IDISBA).
Aina M YáñezDepartment of Nursing and Physiotherapy and Research Group on Global Health and Human Development.
Aurora GarciaResearch Institute of Health Sciences (IUNICS-IDISBA).
Andrea SeguíResearch Institute of Health Sciences (IUNICS-IDISBA).
Francisco GazquezResearch Institute of Health Sciences (IUNICS-IDISBA).
Jose Antonio MarinoResearch Institute of Health Sciences (IUNICS-IDISBA).
Olga IbarraResearch Institute of Health Sciences (IUNICS-IDISBA).
Maria J Serrano-RipollPrimary Care Research Unit of Majorca, Balearic Islands Health Services and Department of Psychology, University of the Balearic Islands, Palma.
Rocio Gomez-JuanesResearch Institute of Health Sciences (IUNICS-IDISBA).
Miquel Bennasar-VenyDepartment of Nursing and Physiotherapy and Research Group on Global Health and Human Development.ORCID 0000-0003-1668-2141
Joan SalvaResearch Institute of Health Sciences (IUNICS-IDISBA).
Bárbara OlivánDepartment of Psychology and Sociology, University of Zaragoza and Preventive Activities and Health Promotion Network, REDIAPP (G06/170), Zaragoza, Spain.
Miquel RocaResearch Institute of Health Sciences (IUNICS-IDISBA).
Margalida GiliResearch Institute of Health Sciences (IUNICS-IDISBA).
Mauro Garcia-ToroResearch Institute of Health Sciences (IUNICS-IDISBA).
Research Institute of Health Sciences · ESRed de Investigación en Actividades Preventivas y Promoción de la Salud · ESUniversitat de les Illes Balears · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTreatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions.

objectiveThe main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD.

methodsThis will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used 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. DISCUSSION: Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures. CLINICALTRIALS REGISTRATION NUMBER: NCT04428099.

Indexed as

Healthy LifestyleTelemedicineCognitive Behavioral TherapyCoronavirus InfectionsCOVID-19Depressive Disorder, Treatment-ResistantHealth PromotionHumansMindfulnessPandemicsPneumonia, ViralPragmatic Clinical Trials as TopicQuality of LifeSurveys and Questionnaires

Identifiers

PMID33157937
PMCPMC7647547
OpenAlexW3095277905

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.