Clinical trial NCT04830553: Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial
Official title: Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Humboldt-Universität zu Berlin
First posted: 2021-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Couples Satisfaction Index, CSI-32.
timeFrame: 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:
measure: Change in Beck's Depression Inventory, BDI-II.
timeFrame: 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.
measure: Change in ICD-10 Symptom Rating, ISR.
timeFrame: 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:
measure: Childhood Trauma Questionnaire, CTQ.
timeFrame: Beginning of the treatment phase. (Note: This outcome measure is only assessed once prior to the treatment phase.)
measure: Positive and Negative Affect Schedule, PANAS.
timeFrame: Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).
measure: Standortbestimmung.
timeFrame: Change from beginning to end of each couple therapy session (i.e., outcome measure applied before and within 10 minutes after each meeting).
measure: Working Alliance Inventory.
timeFrame: 12-month follow-up. (Note: This outcome measure is only assessed once at the 12-month follow-up.)
Locations:
city: Berlin
country: Germany
facility: Humboldt-Universität zu Berlin
Study officials:
affiliation: University Medicine of Greifswald & Medical School Berlin
name: Benjamin Stahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: