Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients

November 19, 2024 updated by: Max-Planck-Institute of Psychiatry

Initial Effect Size Estimation of a Smartwatch-based Intervention for Physical and Behavioral Activation in Depressed Patients: a Pilot-study

It is well known that physical activity interventions have a robust, if small-to-moderate effect on the amelioration of chronic diseases, including major depressive disorder (MDD) (Singh et al. 2023). At the same time, behavioral activation is one of the most effective components of digital cognitive-behavioral therapy for depression (Furakawa et al. 2021). Here we leveraged smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown promising effects in the amelioration of depression. Our primary aim was to estimate the effects of our digital smartwatch-based intervention in a small sample of depressed patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80805
        • Max Planck Institute of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Unmedicated, depressed patients (mildly or moderately depressed).

Description

Inclusion Criteria:

  • Written consent for voluntary study participation
  • Between 18 and 65 years of age
  • Current diagnosis of a single episode of mild to moderate depressive disorder without psychotic symptoms, according to ICD-10 (F32.0, F32.1)
  • Internet access and email address to answer electronic questionnaires
  • Ability to read German

Exclusion Criteria:

  • Acute suicidality
  • Pregnancy and breastfeeding
  • Currently undergoing psychological treatment
  • Current use of psychotropic medication
  • Neurological or internal medical disease
  • Diagnosis of a severe major depression or dysthymia according to ICD-10 (F32.2, F32.3, F33.2, F33.3, F34.1)
  • Diagnosis of a psychotic disorder according to ICD-10 (F20-F29) in the life history
  • Diagnosis of a bipolar disorder according to ICD-10 (F31) in life history
  • Acute substance abuse (e.g., drug use or excessive alcohol and nicotine use)
  • Diagnosis of dissociative disorder (F44) in life history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Intervention group
Group of patients that received the digital intervention
Behavioral: Physical and behavioral smartwatch-based activation
We used smartwatches to provide an interactive tool for delivering a mixed intervention of physical and behavioral activation, with the former addressing physical activity level and the latter pleasant activities including and beyond physical activity (e.g., social, relaxing activities). Moreover, given the relationship with physical activity level, we additionally incorporated digital insomnia exercises that have also shown large effects in the amelioration of depression.
Retrospective control group
Retrospectively collected group of patients from earlier versions (amendments) of the study who filled out the PHQ-9 twice with a certain interval (and were offered the intervention at a later time-point)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PHQ-9
Time Frame: pre to post: 12 weeks
Patient Health Questionnaire
pre to post: 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Max-Planck-Institute of Psychiatry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Victor Spoormaker, PhD, Max-Planck-Institute of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MaxPlanckIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on privacy regulation (removal of all connections to personal identifiers), the aim is to make the primary readout scores available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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