- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04830553
Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial
January 17, 2023 updated by: University Medicine Greifswald
The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of immediate sound feedback for physical distance and touch between individuals as a potential means to complement existing methods in couple therapy.
The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
According to early 20th century psychoanalysis, the "unsaid" becomes apparent in the relationship between patient and therapist, as well as in metaphors and symbols revealed through unintended utterances, imaginative techniques, and dreams.
To convey emotions and thoughts, this method relies on the use of spoken language.
Likewise, spoken language remains central to the practice of psychotherapy in subsequent decades, as clinicians and researchers sought to translate and transform major claims of psychoanalysis into newer paradigms, the most prominent of them being cognitive-behavioral, client-centered and family-systems psychotherapy.
Inspired by somatic psychology and neuroscience evidence, more recent approaches focus on body and movement to target the "unsaid" beyond spoken language.
Funded by the German Federal Ministry of Education and Research, the "Sentire" project attempts to provide immediate sound feedback for physical distance and touch between individuals (www.sentire.me).
The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of "Sentire" as a potential means to complement existing methods in couple therapy.
The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 10117
- Humboldt-Universität zu Berlin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- In couple relationship for at least six months;
- Living in shared household or close daily contact.
Exclusion Criteria:
- Currently acute episode of any mental disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music-based couple therapy.
Each couple will receive five treatment sessions, including established methods from client-centered and family-systems psychotherapy as well as "Sentire," a technological approach providing immediate sound feedback for physical distance and touch.
Duration of the treatment phase: five weeks.
|
Each couple will receive five treatment sessions, including established methods from client-centered and family-systems psychotherapy as well as "Sentire," a technological approach providing immediate sound feedback for physical distance and touch.
Duration of the treatment phase: five weeks.
|
No Intervention: Waiting list.
Each couple will go through an initial waiting period before the treatment phase.
Duration of the waiting period: five weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Couples Satisfaction Index, CSI-32.
Time Frame: Change on the CSI-32, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up.
|
This self-report questionnaire was conceived to quantify various aspects of a person's satisfaction in a couple relationship on a Likert scale ranging from 0 (very low satisfaction) to 6 (very high satisfaction).
|
Change on the CSI-32, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck's Depression Inventory, BDI-II.
Time Frame: Change on the BDI-II, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up.
|
This self-report measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability.
|
Change on the BDI-II, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up.
|
Change in ICD-10 Symptom Rating, ISR.
Time Frame: Change on the ISR, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up.
|
This self-report measure based on the ICD-10 criteria of mental disorders serves as a screening instrument for psychological syndromes.
|
Change on the ISR, as determined by scores on this outcome measure at the beginning, immediately at the end of the five-week treatment phase or five-week waiting-list period, and at 12-month follow-up.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Childhood Trauma Questionnaire, CTQ.
Time Frame: Beginning of the treatment phase. (Note: This outcome measure is only assessed once prior to the treatment phase.)
|
This self-report measure serves as a covariate to determine the relationship between childhood trauma and present issues in a couple relationship.
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Beginning of the treatment phase. (Note: This outcome measure is only assessed once prior to the treatment phase.)
|
Positive and Negative Affect Schedule, PANAS.
Time Frame: Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).
|
This self-report measure serves as an indicator of change in emotional arousal within each couple therapy session.
|
Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).
|
Standortbestimmung.
Time Frame: Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).
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This self-report measure serves as an indicator of subjective benefit from the treatment experienced within each couple therapy session.
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Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).
|
Working Alliance Inventory.
Time Frame: 12-month follow-up. (Note: This outcome measure is only assessed once at the 12-month follow-up.)
|
This self-report measure serves as an indicator of therapeutic relationship quality.
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12-month follow-up. (Note: This outcome measure is only assessed once at the 12-month follow-up.)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin Stahl, PhD, University Medicine of Greifswald & Medical School Berlin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2021
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
October 1, 2022
Study Registration Dates
First Submitted
March 26, 2021
First Submitted That Met QC Criteria
April 1, 2021
First Posted (Actual)
April 5, 2021
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SONIFY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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