Healthy ParticipantsNCT04973839
Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention
A study testing Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR), Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR) and Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR) in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR), Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR) and Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jul 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants
- fluency in the German language to provide informed consent
Who cannot join
- muscle disease, muscle cramps, acute psychosis, acute trauma responses, or another chronic somatic illness
- Mental disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032
About this study
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).
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR), Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR), Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR), Neutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR)Behavioural
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) + Progressive Muscle Relaxation (PMR)Behavioural
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) + Progressive Muscle Relaxation (PMR)Behavioural
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)+ Progressive Muscle Relaxation (PMR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video optimizing expectations before PMR (unguided) | Experimental | watching a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided) Receives: Behavioral: Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR) |
| Video optimizing expectations before PMR (guided) | Experimental | watching a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided) Receives: Behavioral: Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR) |
| Neutral video before PMR (unguided) | Active comparator | watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided), Receives: Behavioral: Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR) |
| Neutral video before PMR (guided) | Active comparator | watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided) Receives: Behavioral: Neutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from pre (baseline) to post scores (30 minutes later)
Secondary outcomes (1)
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.
Measured: Change from pre (baseline) to post scores (30 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start7 Jul 2021
- Primary completion11 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973839
- Sponsor's protocol ID
- augment_PMR
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention
- ClinicalTrials.gov ID
- NCT04973839
- Acronym / sponsor ID
- augment_PMR
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 11 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Video optimizing expectations before PMR (unguided) | Experimental | Behavioral: Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR)watching 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) | Experimental | Behavioral: Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR)watching 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 comparator | Behavioral: Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR)watching 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 comparator | Behavioral: Neutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR)watching a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy participants
- fluency in the German language to provide informed consent
Key exclusion criteria (2 listed)
- muscle disease, muscle cramps, acute psychosis, acute trauma responses, or another chronic somatic illness
- Mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Video optimizing expectations before PMR (unguided) |
| 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. | Behavioural | Video optimizing expectations before PMR (guided) |
| 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. | Behavioural | Neutral video before PMR (unguided) |
| 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. | Behavioural | Neutral video before PMR (guided) |
Primary outcome
Change in perceived stress
Time frame: Change from pre (baseline) to post scores (30 minutes later)
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).
1 secondary outcome
Change in positive affect
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR), Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR) and Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR) in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress (time frame: Change from pre (baseline) to post scores (30 minutes later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.