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Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial

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ClinicalTrials.gov Identifier: NCT04830553
Recruitment Status : Completed
First Posted : April 5, 2021
Last Update Posted : April 20, 2022
Sponsor:
Collaborator:
Humboldt-Universität zu Berlin
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Music-based couple therapy. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial
Actual Study Start Date : March 26, 2021
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


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.
Behavioral: 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.

No Intervention: Waiting list.
Each couple will go through an initial waiting period before the treatment phase. Duration of the waiting period: five weeks.



Primary Outcome Measures :
  1. 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 and immediately at the end of the five-week treatment phase or five-week waiting-list period. ]
    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).


Secondary Outcome Measures :
  1. 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 and immediately at the end of the five-week treatment phase or five-week waiting-list period. ]
    This self-report measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability.

  2. Change in ICD-10 Symptom Rating, ISR. [ Time Frame: Change on the ISR, as determined by scores on this outcome measure at the beginning and immediately at the end of the five-week treatment phase or five-week waiting-list period. ]
    This self-report measure based on the ICD-10 criteria of mental disorders serves as a screening instrument for psychological syndromes.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830553


Locations
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Germany
Humboldt-Universität zu Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
University Medicine Greifswald
Humboldt-Universität zu Berlin
Investigators
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Principal Investigator: Benjamin Stahl, PhD University Medicine of Greifswald
Additional Information:
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT04830553    
Other Study ID Numbers: SONIFY
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms