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

NCT04830553 | Completed

• 1 other identifier: SONIFY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Beck's Depression Inventory, BDI-II.

  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.

  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 Outcomes (4)

• Childhood Trauma Questionnaire, CTQ.

  Beginning of the treatment phase. (Note: This outcome measure is only assessed once prior to the treatment phase.)

• Positive and Negative Affect Schedule, PANAS.

  Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).

• Standortbestimmung.

  Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).

Study Arms (2)

Music-based couple therapy.

EXPERIMENTAL

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.

Waiting list.

NO INTERVENTION

Each couple will go through an initial waiting period before the treatment phase. Duration of the waiting period: five weeks.

Interventions

Music-based couple therapy. BEHAVIORAL

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.

Music-based couple therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In couple relationship for at least six months;
• Living in shared household or close daily contact.

You may not qualify if:

• Currently acute episode of any mental disorder.

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Humboldt-Universität zu Berlin: collaborator

Study Sites (1)

Humboldt-Universität zu Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Benjamin Stahl, PhD

  University Medicine of Greifswald & Medical School Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: March 26, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)