Experimental Group 1 (Video Personal Expert)NCT03330431

Do Videos That Aim to Optimize Expectations Alter the Effectivess of PMR?

A study testing Progressive Muscle Relaxation (PMR) in people with Experimental Group 1 (Video Personal Expert) and Experimental Group 2 (Video Factual Expert), run by Philipps University Marburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study's aim is to determine whether a short video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) ist able to improve the actual effectiveness of PMR in comparison with a neutral (no video) control group. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Experimental Group 1 (Video Personal Expert), Experimental Group 2 (Video Factual Expert), Control Group
What is being tested?: 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: 66 participants
Where: 1 siteGermany
Study dates: 1 Jul 2017to 30 Nov 2017
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

Chronic illness
Mental disorder

Trial locations and contacts

1 site in 1 country.

Germany1 site

Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032

Other trials in Germany

About this study

Official title: Effects of Videos Aiming to Optimize Expectations on Effectiveness of Progressive Muscle Relaxation (PMR)

Conditions: Experimental Group 1 (Video Personal Expert), Experimental Group 2 (Video Factual Expert), Control Group
Being tested: Progressive Muscle Relaxation (PMR)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Progressive Muscle Relaxation (PMR)Behavioural
All groups undergo a PMR session, but they differ regarding the treatment before the PMR session. Two groups watch a video before undergoing PMR, the control group reads a text before undergoing PMR.
Progressive muscle relaxation (PMR) is a technique for learning to monitor and control the state of muscular tension. It was developed by American physician Edmund Jacobson in the early 1920s.
The technique 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 groups in NCT03330431
Study group	Role	What they receive
Experimental group 1 (personal expert)	Experimental	Participants watch a video of an expert describing the positive effects of Progressive Muscle Relaxation (PMR) with personalized examples and stories before undergoing a PMR session. Receives: Behavioral: Progressive Muscle Relaxation (PMR)
Experimental group 2 (factual expert)	Experimental	Participants watch a video of an expert describing the positive effects of Progressive Muscle Relaxation (PMR) with factual information (not personal) before undergoing a PMR session. Receives: Behavioral: Progressive Muscle Relaxation (PMR)
Control group	Active comparator	Participants read a neutral text before undergoing a Progressive Muscle Relaxation (PMR) session. Receives: Behavioral: Progressive Muscle Relaxation (PMR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in perceived/subjective relaxation
Participants are asked to rate how relaxed they feel at the moment at two time points (baseline and after the PMR intervention) on a questionnaire (VAS: item ranges from 0 (not relaxed at all) - 100 (very relaxed). Change scores are calculated (post- minus pre-scores).
Measured: Change from pre (baseline) to post scores (30 minutes later)

Secondary outcomes (2)

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).
Measured: Change from pre (baseline) to post scores (30 minutes later)
Change in physiological relaxation
Electromyography is used to assess participants' physiological relaxation status at baseline and after the PMR intervention. Change scores are calculated (post- minus pre-scores).
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.

1 Jul 201730 Nov 2017

First posted6 Nov 2017
Study start1 Jul 2017
Primary completion15 Sep 2017
Study completion30 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Experimental Group 1 (Video Personal Expert)Studies 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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03330431
Sponsor's protocol ID: 2017_EXPECT_v1
Status last verified: Jul 2020
First submitted: 27 Sep 2017
Last updated: 2 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Salzmann S, Wilhelm M, Schindler S, Rief W, Euteneuer F. Optimising the efficacy of a stress-reducing psychological intervention using placebo mechanisms: A randomized controlled trial. Stress Health. 2022 Oct;38(4):722-735. doi: 10.1002/smi.3128. Epub 2022 Jan 24.
PubMed 35043534

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Videos Aiming to Optimize Expectations on Effectiveness of Progressive Muscle Relaxation (PMR)
ClinicalTrials.gov ID: NCT03330431
Acronym / sponsor ID: 2017_EXPECT_v1
Conditions: Experimental Group 1 (Video Personal Expert), Experimental Group 2 (Video Factual Expert), Control Group
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Philipps University MarburgUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 15 Sep 2017 (actual)
Study completion: 30 Nov 2017 (actual)
First posted: 6 Nov 2017 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Experimental group 1 (personal expert)	Experimental	Behavioral: Progressive Muscle Relaxation (PMR)Participants watch a video of an expert describing the positive effects of Progressive Muscle Relaxation (PMR) with personalized examples and stories before undergoing a PMR session.
Experimental group 2 (factual expert)	Experimental	Behavioral: Progressive Muscle Relaxation (PMR)Participants watch a video of an expert describing the positive effects of Progressive Muscle Relaxation (PMR) with factual information (not personal) before undergoing a PMR session.
Control group	Active comparator	Behavioral: Progressive Muscle Relaxation (PMR)Participants read a neutral text before undergoing a Progressive Muscle Relaxation (PMR) session.

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)

Chronic 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
Progressive Muscle Relaxation (PMR)All groups undergo a PMR session, but they differ regarding the treatment before the PMR session. Two groups watch a video before undergoing PMR, the control group reads a text before undergoing PMR. Progressive muscle relaxation (PMR) is a technique for learning to monitor and control the state of muscular tension. It was developed by American physician Edmund Jacobson in the early 1920s. The technique 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	Control group, Experimental group 1 (personal expert), Experimental group 2 (factual expert)

Primary outcome

Change in perceived/subjective relaxation
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Participants are asked to rate how relaxed they feel at the moment at two time points (baseline and after the PMR intervention) on a questionnaire (VAS: item ranges from 0 (not relaxed at all) - 100 (very relaxed). Change scores are calculated (post- minus pre-scores).

2 secondary outcomes

Change in perceived stress
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Change in physiological relaxation
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 2 Jul 2020.
Derived from this study: PubMed 35043534Salzmann S, Wilhelm M, Schindler S, Rief W, Euteneuer F. Optimising the efficacy of a stress-reducing psychological intervention using placebo mechanisms: A randomized controlled trial. Stress Health. 2022 Oct;38(4):722-735. doi: 10.1002/smi.3128. Epub 2022 Jan 24.

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.

Winfried Rief, Professor principal investigator

Philipps University Marburg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 Jul 2020. 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/subjective relaxation (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?

On the ClinicalTrials.gov record for NCT03330431, which also lists 1 linked publication.

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 2 Jul 2020.