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

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: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Physical and behavioral smartwatch-based activation

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
PHQ-9	Patient Health Questionnaire	pre to post: 12 weeks

Collaborators and Investigators

• Sponsor: Max-Planck-Institute of Psychiatry
• Investigators: Principal Investigator: Victor Spoormaker, PhD, Max-Planck-Institute of Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID 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