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

NCT06532097 | Completed

• 1 other identifier: MaxPlanckIP
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• PHQ-9

  Patient Health Questionnaire

  pre to post: 12 weeks

Study Arms (2)

Intervention group

Group of patients that received the digital intervention

Behavioral: Physical and behavioral smartwatch-based activation

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)

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unmedicated, depressed patients (mildly or moderately depressed).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, Bavaria, 80805, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Victor Spoormaker, PhD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: March 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-03

Locations

DE (1)