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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06532097
Enrollment
53
Registered
2024-08-01
Start date
2023-03-01
Completion date
2024-01-31
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

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.

Interventions

BEHAVIORALPhysical 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.

Sponsors

Max-Planck-Institute of Psychiatry
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PHQ-9pre to post: 12 weeksPatient Health Questionnaire

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026