Depression
Conditions
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.
Interventions
BEHAVIORALMusic-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.
Sponsors
Humboldt-Universität zu Berlin
University Medicine Greifswald
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Couples Satisfaction Index, CSI-32. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | This self-report measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability. |
| 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. | This self-report measure based on the ICD-10 criteria of mental disorders serves as a screening instrument for psychological syndromes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Childhood Trauma Questionnaire, CTQ. | 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. |
| Working Alliance Inventory. | 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. |
| 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). | This self-report measure serves as an indicator of change in emotional arousal within each couple therapy session. |
| Standortbestimmung. | 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. |
Countries
Germany
Outcome results
None listed