Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention
1 other identifier
interventional
90
1 country
1
Brief Summary
This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2021
CompletedFirst Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedAugust 7, 2024
August 1, 2024
2 months
July 13, 2021
August 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in perceived stress
Participants are asked to rate how stressed they feel at the moment at two time points (baseline and after the PMR intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores). More negative change scores are better since it indicates a stronger stress reduction (maximum reduction: -100). Higher positive change scores are worse since this indicates an increase in perceived stress (maximum increase: +100). Range of change scores: -100 - +100).
Change from pre (baseline) to post scores (30 minutes later)
Secondary Outcomes (1)
Change in positive affect
Change from pre (baseline) to post scores (30 minutes later)
Study Arms (4)
Video optimizing expectations before PMR (unguided)
EXPERIMENTALwatching a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided)
Video optimizing expectations before PMR (guided)
EXPERIMENTALwatching a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided)
Neutral video before PMR (unguided)
ACTIVE COMPARATORwatching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided),
Neutral video before PMR (guided)
ACTIVE COMPARATORwatching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided)
Interventions
Participants watch a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided). The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
Participants watch a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided). The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
Participants watch a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided). The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
Participants watch a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided).The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
Eligibility Criteria
You may qualify if:
- Healthy participants
- fluency in the German language to provide informed consent
You may not qualify if:
- muscle disease, muscle cramps, acute psychosis, acute trauma responses, or another chronic somatic illness
- Mental disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 22, 2021
Study Start
July 7, 2021
Primary Completion
September 11, 2021
Study Completion
September 15, 2021
Last Updated
August 7, 2024
Record last verified: 2024-08