Improving Depressive Symptoms Through Personalised Exercise and Activation

NCT04857944 | Completed

• 1 other identifier: PI19/00009
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Depressive symptoms; Exercise; Personalized medicine; Blended intervention; Transdisciplinary

Outcome Measures

Primary Outcomes (1)

• Psychosocial and occupational functioning

  The Functioning Assessment Short Test (FAST) will be used to assess the change in psychosocial and occupational functioning comparing subjects allocated to both experimental conditions (A+B) vs the control condition. The FAST is a simple self-administered instrument that comprises 24 items. It assesses impairment or disability in six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.

  Baseline, 4 weeks, 12 weeks, and 36 weeks.

Secondary Outcomes (4)

• Depressive symptomatology

  Baseline, 4 weeks, 12 weeks, and 36 weeks.

• Well-being

  Baseline, 4 weeks, 12 weeks, and 36 weeks.

• Exercise motives

  Baseline to week 36.

• Physical and social functioning

  Baseline, 4 weeks, 12 weeks, and 36 weeks.

Other Outcomes (5)

• Physical Activity

  Baseline, 4 weeks,12 weeks, and 36 weeks.

• Aerobic capacity and endurance

  Baseline to week 36.

• Functional exercise capacity and leg muscle strength

  Baseline to week 36.

Study Arms (3)

Personalised exercise group program + fitness tracker + app with motivational messages (A)

EXPERIMENTAL

After study entry and baseline assessments, subjects will attend the one-month IDEA group sessions aimed at promoting physical activity and exercise. Participants randomly assigned to this study arm will use the smart band and the app with the motivation set enabled, allowing participants to receive the messages according to their compliance and adherence to the personalised prescriptions. After group sessions (week 4), study subjects will start receiving motivational messages up until the end of the trial (8 consecutive months).

Behavioral: IDEA program (Improving depressive symptoms through personalised exercise and activation); Device: IDEApp

Personalised exercise group program + fitness tracker + app without motivational messages (B)

EXPERIMENTAL

Subjects will follow the same procedure as intervention A, with the difference that the app will have the motivation set disabled, therefore participants will not receive any messages regarding their compliance. After group sessions, study subjects will be expected to continue using the smart band and app up until the end of the trial (8 consecutive months).

Behavioral: IDEA program (Improving depressive symptoms through personalised exercise and activation); Device: IDEApp

Fitness tracker + app without motivational messages (CG)

SHAM COMPARATOR

After study entry and baseline assessments, all patients assigned to the control group will receive both the app and the smart band, but the motivation set will be disabled. Study subjects will be expected to use the smart band and app up until the end of the trial.

Device: IDEApp

Interventions

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

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.

Personalised exercise group program + fitness tracker + app with motivational messages (A); Personalised exercise group program + fitness tracker + app without motivational messages (B)

IDEApp DEVICE

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.

Fitness tracker + app without motivational messages (CG); Personalised exercise group program + fitness tracker + app with motivational messages (A); Personalised exercise group program + fitness tracker + app without motivational messages (B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>18-\<65 years
• Presenting mild to moderate depressive symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS score\>16 \& \<34)
• Currently owning an Android compatible smartphone
• Fluent in the Spanish language
• Basic knowledge and skills using information and communication technology
• Be able to provide written informed consent to participate

You may not qualify if:

• Severe cognitive and/or physical impairment
• Cognitive deficit or developmental disorder
• Current psychotic, melancholic, or catatonic features
• Drug or alcohol abuse
• Modification of drug treatment (or its dose) in the last month (or plan for it
• Beginning of psychological treatment in the last month
• Beginning of biophysical treatment in the last month
• BMI \>40
• Physical disability.

Sponsors & Collaborators

• Hospital del Mar Research Institute (IMIM): lead
• Instituto de Salud Carlos III: collaborator
• Parc de Salut Mar: collaborator

Study Sites (1)

Centre Fòrum (Consorci Mar Parc de Salut de Barcelona)

Barcelona, Catalonia, 08019, Spain

Location

Related Publications (1)

• Garcia-Estela A, Angarita-Osorio N, Alonso S, Polo M, Roldan-Berengue M, Messaggi-Sartor M, Mur-Mila E, Vargas-Puertolas L, Perez V, Duarte E, Colom F. Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial. Int J Environ Res Public Health. 2021 Jun 10;18(12):6306. doi: 10.3390/ijerph18126306.

  PMID: 34200805 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Esther Duarte, Dr

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

• Francesc Colom, Dr

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After assignment to study conditions, participants and investigators will be blinded to one aspect of the specific experimental intervention (receiving or not motivational messages). Both will know whether participants have been allocated to experimental or control conditions but the specific experimental intervention (A or B) will not be revealed. To avoid assessment bias, an independent evaluator blinded to group allocation will complete follow-up assessments. Clinicians, principal investigators, and statisticians will be also blinded to the randomization procedure and group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group leader and senior researcher

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 23, 2021
• Study Start: June 7, 2021
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

ES (1)