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Improving Depressive Symptoms Through Personalised Exercise and Activation (IDEA)

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ClinicalTrials.gov Identifier: NCT04857944
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Parc de Salut Mar
Information provided by (Responsible Party):
Francesc Colom, Hospital del Mar Research Institute (IMIM)

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.


Condition or disease Intervention/treatment Phase
Depressive Symptoms Depressive Disorder Behavioral: IDEA program (Improving depressive symptoms through personalised exercise and activation) Device: IDEApp Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Personalised Exercise Prescription: the Efficiency of a Transdisciplinary Blended Intervention in Depressive Symptoms
Estimated Study Start Date : April 26, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalised exercise group program + fitness tracker + app with motivational messages (A)
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)
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.

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

Sham Comparator: Fitness tracker + app without motivational messages (CG)
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
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.




Primary Outcome Measures :
  1. Psychosocial and occupational functioning [ Time Frame: Baseline, 4 weeks, 12 weeks, and 36 weeks. ]

    The 36-item Short-Form Health Survey (SF-36) 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 SF-36 is a 36-item, self-administered questionnaire used to assess general health status, and it includes eight health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The scores of each domain depend on the number of items in them; however, these scores are transformed on a scale from 0 to 100, where higher scores indicate less disability and better general health status.



Secondary Outcome Measures :
  1. Depressive symptomatology [ Time Frame: Baseline, 4 weeks, 12 weeks, and 36 weeks. ]

    The Patient Health Questionnaire (PHQ-9) will be used to assess the severity and improvement of depressive symptomatology.

    The PHQ-9 is a self-administered questionnaire used to screen the presence and severity of depression. It has 9 items on a scale from 0 (not at all) to 3 (nearly every day), the total score ranges from 0 to 27, with higher scores meaning severe depressive symptomatology.


  2. Well-being [ Time Frame: Baseline, 4 weeks, 12 weeks, and 36 weeks. ]

    Well-being will be assessed by the World Health Organization Well-Being Index (WHO-5).

    The WHO-5 a 5-item self-administered questionnaire used to assess current mental well-being. The rating scores go from 0 (at no time) to 5 (all of the time), with total scores ranging from 0 to 100, where higher scores mean the best imaginable well-being.


  3. Exercise motives [ Time Frame: Baseline to week 36. ]

    The Exercise Motivations Inventory (EMI-2) will be used to identify participants' motives to initiate and adhere to the personalised exercise prescription, and if they have changed during the trial.

    The EMI-2 is a 51-item, self-administered questionnaire used to assess the motives that are related to the practice of exercise. The rating scores go from 0 (not true at all for me) to 10 (totally true for me). Scores can be interpreted according to three different options: analysing individual items, analysing the 5 main areas (psychological, interpersonal, health, appearance and physical form), or a global score. Higher scores on either option mean that those reasons are what motivate exercise practise.



Other Outcome Measures:
  1. Physical Activity [ Time Frame: Baseline, 4 weeks,12 weeks, and 36 weeks. ]

    The Simple Physical Activity Questionnaire (SIMPAQ) will be used to assess change in the percentage of practise of physical activity and sedentary time.

    The SIMPAQ is a 5-item clinical interview used to assess physical activity in a population at risk of high sedentary behaviour. The items assess time in bed, sedentary time, time spent walking, structured exercise and incidental or non-structured physical activity. It does not include scoring indications but aims to evaluate the physical activity to be able to increase it and reduce sedentary behaviour.


  2. Aerobic capacity and endurance [ Time Frame: Baseline to week 36. ]

    Changes in performance capacity assessed by the 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the distance a person can walk in the time frame of 6 minutes. There is no scoring instruction, as the results depend on individual variables and the own subject becomes its control.

    Heath rate, oxygen saturation, dyspnoea will be assessed before and after the test.

    To assess the fatigued cause by the test a reduced Borg scale will be used.


  3. Functional exercise capacity and leg muscle strength [ Time Frame: Baseline to week 36. ]

    Changes in exercise capacity and leg muscle strength evaluated by the 1-Min Sit to Stand Test (1MSTS).

    The 1MSTS consists of getting up from and sitting on a chair as fast as possible within one minute. The scoring includes counting how many times the person repeats the action. Fatigue perceived after the test will be rated using a modified Borg scale.


  4. Functional exercise capacity and isometric muscle strength [ Time Frame: Baseline to week 36. ]

    Changes in functional exercise capacity and isometric muscle strength will be assessed by the Handgrip Strength Test.

    The Handgrip Strength Test will be performed using a Jamar Plus+ digital hand dynamometer; grip strength will be measured three times per hand in the 2-handle position. A mean score of the three tries will be calculated, and the fatigue caused by the test will be assessed with the reduced Borg scale.


  5. Activity and sleep patterns [ Time Frame: Baseline to week 36. ]
    Changes in Activity and sleep patterns based on objective data collected by a fitness tracker (Xiaomi Mi Band 5). This wearable device will collect data including the number of daily steps, aerobic exercise (minutes, distance in meters, maximum, minimum, and average heart rate) and sleep structure (time of sleep per 24-hour period, deep and light sleep discrimination).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857944


Contacts
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Contact: Francesc Colom, Dr +34 93 316 04 00 ext 1493 fcolom@imim.es
Contact: Esther Duarte, Dr +34933674214 eduarte@parcdesalutmar.cat

Locations
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Spain
Centre Fòrum (Consorci Mar Parc de Salut de Barcelona) Recruiting
Barcelona, Catalonia, Spain, 08019
Contact: Francesc Colom, Dr    +34 93 316 04 00 ext 1493    fcolom@imim.es   
Contact: Esther Duarte, Dr    +34933674214    eduarte@parcdesalutmar.cat   
Principal Investigator: Francesc Colom, Dr         
Principal Investigator: Esther Duarte, Dr         
Sponsors and Collaborators
Hospital del Mar Research Institute (IMIM)
Instituto de Salud Carlos III
Parc de Salut Mar
Investigators
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Principal Investigator: Esther Duarte, Dr Parc de Salut Mar
Principal Investigator: Francesc Colom, Dr Parc de Salut Mar
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Responsible Party: Francesc Colom, Group leader and senior researcher, Hospital del Mar Research Institute (IMIM)
ClinicalTrials.gov Identifier: NCT04857944    
Other Study ID Numbers: PI19/00009
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesc Colom, Hospital del Mar Research Institute (IMIM):
Depressive symptoms
Exercise
Personalized medicine
Blended intervention
Transdisciplinary
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms