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An open-label-placebo RCT for improving psychological distress in highly stressed students: The impact of pharmaceutical form and simulated side effects

An open-label-placebo RCT for improving psychological distress in highly stressed students: The impact of pharmaceutical form and simulated side effects - EDMONT_OLP_FIELD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030987
Enrollment
180
Registered
2023-01-02
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

perceived stress

Interventions

Group 1: Placebo nasal spray active for 7 days Group 2: Placebo nasal spray passive for 7 days Group 3: Placebo capsule passive for 7 days Group 4: No intervention (7 days natural history)

Sponsors

Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: German speaking stress level (PSS-10 > 20)

Exclusion criteria

Exclusion criteria: allergies against ingredients of Placebo severe asthma

Design outcomes

Primary

MeasureTime frame
Change in stress (PSS-10) from baseline to day 8 of participation

Secondary

MeasureTime frame
Change in psychological distress (DASS-21) from baseline to day 8 of participation

Countries

Germany

Contacts

Public ContactAlexander Winkler

Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen

Alexander.Winkler@psychol.uni-giessen.de+49 641 99-26084

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026