Improving Depressive Symptoms Through Personalised Exercise and Activation

Summary

The purpose of the present study is to evaluate the changes on mental and physical health deriving from a blended intervention merging psychological intervention aimed at increasing activity and exercise with a personalised exercise program based on medical assessment on subjects suffering from mild to moderate depressive symptoms irrespective of diagnostic entity, by comparing two experimental groups (A. Personalised exercise group program+ app with motivational messages + fitness tracker or B. Personalised exercise group program+ app with no motivational messages + fitness tracker) and a control group (app with no motivational messages +fitness tracker). This study also introduces the use of a wearable device to collect information regarding physical activity and sleep patterns to provide motivational messages.

The investigators hypothesise that participation in a brief app-blended group intervention -on top of usual care- promoting personalised exercise and activity will improve functioning and well-being of participants, as well as motivate them to increase their physical activity and enhance behavioural changes towards a healthier lifestyle when compared to general exercise prescriptions. In addition, the investigators hypothesise that amongst patients who had been allocated to the intervention conditions, those presenting better commitment to prescribed personalised exercise plans (understood as more than a 70% compliance of prescribed exercise, measured by objective movement data collected by a fitness tracker) will show a higher functionality improvement.

Conditions

• Depressive Symptoms
• Depressive Disorder

Interventions

BEHAVIORAL

IDEA program (Improving depressive symptoms through personalised exercise and activation)

The program will consist of six 90-minute group sessions composed of four to six participants. These short intervention sessions will be distributed in one month, with a frequency of once or twice a week depending on the week of the program. Of the six sessions, two will be exercise-oriented and will include on-site practice. The remaining four sessions will include definitions of depressive symptomatology, the relationship between depression and having an active lifestyle, motivation and barriers towards exercise, and maintenance strategies.

DEVICE

IDEApp

An ad-hoc app (IDEApp) combined with a fitness tracker to register and store participants' physical activity, exercise compliance, and sleep patterns. The app will deliver motivational or awareness messages when the fitness tracker detects non-compliance with the exercise prescription, physical activity decreases, or altered sleep patterns.

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Parc de Salut Mar

  collaborator OTHER

• Hospital del Mar Research Institute (IMIM)

  lead OTHER

Principal Investigators

• Esther Duarte, Dr · Parc de Salut Mar

• Francesc Colom, Dr · Parc de Salut Mar

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-07

Primary Completion

2024-07-08

Completion

2024-07-08

Countries

• Spain

Study Locations