An interventional study of Music-based couple therapy. in Depression, sponsored by University Medicine Greifswald. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by University Medicine Greifswald · Not applicable, Interventional, and Treatment
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.
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.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University Medicine Greifswald is the lead sponsor of 152 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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 go through an initial waiting period before the treatment phase. Duration of the waiting period: five weeks.
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.
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).
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.
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.
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.
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.
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.
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.
Time frame: Beginning of the treatment phase. (Note: This outcome measure is only assessed once prior to the treatment phase.)
Positive and Negative Affect Schedule, PANAS.
This self-report measure serves as an indicator of change in emotional arousal within each couple therapy session.
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).
Standortbestimmung.
This self-report measure serves as an indicator of subjective benefit from the treatment experienced within each couple therapy session.
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).
Working Alliance Inventory.
This self-report measure serves as an indicator of therapeutic relationship quality.
Time frame: 12-month follow-up. (Note: This outcome measure is only assessed once at the 12-month follow-up.)
Plan to share: No
Ran from Mar 2021 to primary completion in Apr 2022, 12 months.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 12 months is below that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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