to study search History

CBD-oil to reduce stress and psychological distress in stressed students

Organizational Data

DRKS-ID:
DRKS00030971
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2022-12-22
Last update in DRKS:
2023-12-04
Registration type:
Prospective

Acronym/abbreviation of the study

CBD

URL of the study

No Entry

Brief summary in lay language

Aim of the study is to assess the effect of a daily sublingual application of an over the counter 10% full spectrum CBD-oil over 30 days on perceived stress and psychological distress. Another goal is to assess the role of treatment expectation on the efficacy of the treatment.

Brief summary in scientific language

Aim of the study is to assess the effect of a daily sublingual application of an over the counter 10% full spectrum CBD-oil over 30 days, compared to a placebo-oil and a natural history group without application of any oil on perceived stress and psychological distress in a sample of stressed students. Another goal is to assess the role of treatment expectation on the efficacy of the treatment.

Health condition or problem studied

Free text:
perceived stress
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
10% full spectrum CBD-oil for 30 days
Arm 2:
Placebo-oil for 30 days
Arm 3:
No oil (30 day natural history)

Endpoints

Primary outcome:
Change in stress (PSS-10) from baseline to day 30 of intervention
Secondary outcome:
Change in psychological distress (DASS-21) from baseline to day 30 of intervention

Study Design

Purpose:
Basic research/physiological study
Allocation:
Randomized controlled study
Control:
  • Placebo
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen Gießen

Recruitment period and number of participants

Planned study start date:
2023-01-09
Actual study start date:
2023-01-16
Planned study completion date:
2023-12-31
Actual Study Completion Date:
2023-12-01
Target Sample Size:
180
Final Sample Size:
180

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
45 Years
Additional Inclusion Criteria:
students German speaking elevated stress level

Exclusion Criteria

allergies against ingredients of CBD and Placebo known chronic or acute disease or psychatric disorder regular intake of medication regular intake of CBD product within the last 4 weeks body weight >85kg

Addresses

Primary Sponsor

Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen
Dr. Alexander Winkler
Otto-Behaghel-Straße 10F
35394 Gießen
Germany
Telephone:
+49 641 99-26084
Fax:
+49 641 99-26099
Contact per E-Mail
URL:
https://www.uni-giessen.de/de/fbz/fb06/psychologie/abt/psychologie/klinische/mitarbeiter/winkler
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen
Dr. Alexander Winkler
Otto-Behaghel-Straße 10F
35394 Gießen
Germany
Telephone:
+49 641 99-26084
Fax:
+49 641 99-26099
Contact per E-Mail
URL:
https://www.uni-giessen.de/de/fbz/fb06/psychologie/abt/psychologie/klinische/mitarbeiter/winkler

Contact for Public Queries

Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen
Dr. Alexander Winkler
Otto-Behaghel-Straße 10F
35394 Gießen
Germany
Telephone:
+49 641 99-26084
Fax:
+49 641 99-26099
Contact per E-Mail
URL:
https://www.uni-giessen.de/de/fbz/fb06/psychologie/abt/psychologie/klinische/mitarbeiter/winkler

Principal Investigator

Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen
Dr. Alexander Winkler
Otto-Behaghel-Straße 10F
35394 Gießen
Germany
Telephone:
+49 641 99-26084
Fax:
+49 641 99-26099
Contact per E-Mail
URL:
https://www.uni-giessen.de/de/fbz/fb06/psychologie/abt/psychologie/klinische/mitarbeiter/winkler

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Abt. Klinische Psychologie und Psychotherapie der Justus-Liebig-Universität Gießen
Otto-Behaghel-Straße 10F
35394 Gießen
Germany
Telephone:
+49 641 99-26084
Fax:
+49 641 99-26099
Contact per E-Mail
URL:
https://www.uni-giessen.de/de/fbz/fb06/psychologie/abt/psychologie/klinische/mitarbeiter/winkler

Ethics Committee

Address Ethics Committee

Lokale Ethikkommission des Fachbereich 06
Otto-Behaghel-Straße 10 C
D-35394 Gießen
Germany
Telephone:
+49641/99 - 26014
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-08-11
Ethics committee number:
2022-0025
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-09-17

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
2022-004129-34
UTN (Universal Trial Number):
U1111-1286-1545
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Individual aggregated participant data will be provided after publication on a suitable platform (e.g. Zenodo).

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry