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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Max Planck Institute of Psychiatry

Munich, Bavaria, 80805, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical and behavioral smartwatch-based activation

Behavioral

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.

Primary outcomes

PHQ-9

Time frame: pre to post: 12 weeks

Patient Health Questionnaire

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Aug 1, 2024
Registry last updated: Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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