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

NCT ID: NCT04973839

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2021-09-15

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR)

Intervention Type BEHAVIORAL

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.

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)

Group Type EXPERIMENTAL

Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR)

Intervention Type BEHAVIORAL

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.

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),

Group Type ACTIVE_COMPARATOR

Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR)

Intervention Type BEHAVIORAL

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.

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)

Group Type ACTIVE_COMPARATOR

Neutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Winfried Rief

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychology, Philipps University Marburg

Marburg, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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augment_PMR

Identifier Type: -

Identifier Source: org_study_id

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