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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830553
• Other study ID #: SONIFY
• Status: Completed
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
Germany	Humboldt-Universität zu Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Humboldt-Universität zu Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Childhood Trauma Questionnaire, CTQ.	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.)
Other	Positive and Negative Affect Schedule, PANAS.	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).
Other	Standortbestimmung.	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).
Other	Working Alliance Inventory.	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.)
Primary	Change in Couples Satisfaction Index, CSI-32.	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	Change in Beck's Depression Inventory, BDI-II.	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.
Secondary	Change in ICD-10 Symptom Rating, ISR.	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.

External Links

•   Study website.