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Completed

NCT Number: NCT04830553

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humboldt-Universität zu Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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, 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).

Secondary outcomes

  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, 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.

  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, 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.

Other outcomes

  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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Humboldt-Universität zu Berlin

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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