Lifestyle physical activity coaching in outpatients with major depressive disorder (PACOUTPAT): Randomized controlled trial on physical activity, depression and quality of life

Lifestyle physical activity coaching in outpatients with major depressive disorder (PACOUTPAT): Randomized controlled trial on physical activity, depression and quality of life - PACOUTPAT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036209

Enrollment

114

Registered

2025-05-08

Start date

2025-06-02

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

F32 F33

Interventions

Group 1: 10-week “interest- and experience-based” physical activity coaching supported by wearing a smart ring to support self-monitoring Group 2: 10-week “interest- and experience-based” physical act

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - Outpatients in a day clinic, - Doctor-diagnosed depressive disorder (F32, F33), - Sufficient knowledge of the German language to understand instructions and complete questionnaires - Signed written informed consent and voluntary participation in the study

Exclusion criteria

Exclusion criteria: - Medical contraindications to physical activity assessed by a practitioner and indicated by the physical activity readiness questionnaire - Patients suffering from psychosis and/or acute suicidality - Pregnancy or breast feeding at the time of assessment

Design outcomes

Primary

Measure	Time frame
Device-based physical activity at post- and follow-up-test, as assessed by a Fibion® device.	—

Secondary

Measure	Time frame
- Post- and follow-up-test of self-reported physical activity, as assessed by 7DPAR. - Post- and follow-up-test of depressive symptom severity, as assessed by HAMD17 and BDI-II. - Post- and follow-up-test of HRQoL, as assessed by SF-12. - Post- and follow-up-test of psychological mechanisms (social-cognitive and affective determinants), as assessed by multiple internationally accepted instruments. - Post- and follow-up-test of physical self-perception, as assessed by PSDQ. - Exploratory: A qualitative study will be embedded in the RCT to obtain information on how participants perceived the new physical activity coaching intervention. - Exploratory: An implementation evaluation will be conducted to assess the effectiveness of the physical activity coaching intervention.	—

Measure

Time frame

- Post- and follow-up-test of self-reported physical activity, as assessed by 7DPAR. - Post- and follow-up-test of depressive symptom severity, as assessed by HAMD17 and BDI-II. - Post- and follow-up-test of HRQoL, as assessed by SF-12. - Post- and follow-up-test of psychological mechanisms (social-cognitive and affective determinants), as assessed by multiple internationally accepted instruments. - Post- and follow-up-test of physical self-perception, as assessed by PSDQ. - Exploratory: A qualitative study will be embedded in the RCT to obtain information on how participants perceived the new physical activity coaching intervention. - Exploratory: An implementation evaluation will be conducted to assess the effectiveness of the physical activity coaching intervention.

—

Countries

Switzerland

Contacts

Public ContactCéline Stark

Universität Basel, Departement für Sport, Bewegung und Gesundheit

celine.stark@unibas.ch+41612074771

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026