Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention

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).

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Behavioral: Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR); Behavioral: Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR); Behavioral: Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR); Behavioral: Neutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR)

Detailed Description

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 session 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). After the baseline assessment, participants are randomized to one of 4 possible intervention groups: i) watching a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided), ii) watching a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided), iii) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided), or iv) watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided). In a pre-posttest design, the subjective stress levels of the participants in the for groups will be analyzed.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Salzmann, PhD; Phone Number: +4964212823350; Email: stefan.salzmann@uni-marburg.de

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35032
      • Recruiting
      • Department of Psychology, Philipps University Marburg
      • Contact: Stefan Salzmann, PhD; Phone Number: +496421-2823350; Email: stefan.salzmann@staff.uni-marburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy participants
• fluency in the German language to provide informed consent

Exclusion Criteria:

• muscle disease, muscle cramps, acute psychosis, acute trauma responses, or another chronic somatic illness
• Mental disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video optimizing expectations before PMR (unguided); watching a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided)	Behavioral: Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR); 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.
Experimental: Video optimizing expectations before PMR (guided); watching a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided)	Behavioral: Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR); 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.
Active Comparator: Neutral video before PMR (unguided); watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided),	Behavioral: Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR); 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.
Active Comparator: Neutral video before PMR (guided); watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided)	Behavioral: Neutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in positive affect	Participants are asked to rate adjectives regarding their current mood (positive and negative) at two time points (baseline and after the PMR intervention) on a questionnaire. Change scores are calculated (post- minus pre-scores). Instrument: Positive and Negative Affect Scale (PANAS) by Watson, Clark, and Tellegen (1988) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Range for sum score of positive/negative affect: 10-50. For positive affect higher scores are better; for negative affect lower scores are better.	Change from pre (baseline) to post scores (30 minutes later)

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Anticipated): September 15, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: augment_PMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No