DepressionNCT04830553
Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial
A study testing Music-based couple therapy. in people with Depression, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Music-based couple therapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 26 Mar 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In couple relationship for at least six months;
- Living in shared household or close daily contact.
Who cannot join
- Currently acute episode of any mental disorder.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Music-based couple therapy.
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-based couple therapy.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
This self-report measure of depression severity is known for its good psychometric properties, including construct validity and test-retest reliability.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start26 Mar 2021
- Primary completion1 Apr 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Responsible party
- Sponsor
- Investigators
- Benjamin Stahl, PhD, Principal investigator, University Medicine of Greifswald & Medical School Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830553
- Sponsor's protocol ID
- SONIFY
- Status last verified
- Jan 2023
- First submitted
- 26 Mar 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial
- ClinicalTrials.gov ID
- NCT04830553
- Acronym / sponsor ID
- SONIFY
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music-based couple therapy. | Experimental | Behavioral: Music-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. |
| Waiting list. | No intervention | –Each couple will go through an initial waiting period before the treatment phase. Duration of the waiting period: five weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In couple relationship for at least six months;
- Living in shared household or close daily contact.
Key exclusion criteria (1 listed)
- Currently acute episode of any mental disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-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. | Behavioural | Music-based couple therapy. |
Primary outcome
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).
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Study website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Stahl, PhD principal investigator
University Medicine of Greifswald & Medical School Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-based couple therapy. in people with Depression, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.