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

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.
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).
This self-report measure serves as an indicator of subjective benefit from the treatment experienced 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).
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.
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.

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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