LonelinessPhase 1NCT04137432
Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention for Loneliness
A Phase 1 study testing Oxytocin nasal spray in people with Loneliness, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the clinical potential of oxytocin (OT) as an adjunct to a cognitive-behavioral group-based shortterm intervention for participants suffering from loneliness. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 26 Sep 2019to Dec 2020
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- UCLA loneliness scale score equal to or greater than 55
Who cannot join
- current psychiatric illness
- current psychiatric medication or psychotherapy
- MRI contraindication (e.g. metal in body, claustrophobia)
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention on Neural and Behavioral Correlates of Loneliness
The purpose of this study is to evaluate the clinical potential of oxytocin (OT) as an adjunct to a cognitive-behavioral group-based shortterm intervention for participants suffering from loneliness.
Read the detailed description
Loneliness has a high prevalence in Western societies and poses a significant health problem. Among its many implications, loneliness has been associated with increased risk for coronary heart disease and stroke, depression, cognitive decline, dementia, and mortality. At the neural level, several networks may be involved in loneliness, including the reward circuitry, which mediates social reward, and the amygdala, which signals social threat. Intranasal OT has been reported to regulate activity in both the reward system and the amygdala. Therefore, it may serve as an adjunct to a cognitive-behavioral short-term intervention for high lonely participants.
In this randomized, double-blind, placebo-controlled design study, effects of intranasal OT (24 international units (UI)) as a pharmacological augmentation given before the start of four sessions of a cognitive-behavioral short-term intervention in groups of six to eight participants (based on established interpersonal psychotherapy modules to reduce loneliness) will be investigated. Healthy, but high lonely participants will complete functional magnetic resonance imaging (fMRI) tasks in a separate testing session before the start of the intervention (testing session 1). In the first session of the intervention, the psychotherapist will inform the participants about the procedure of the intervention and participants will get to know the other participants in their intervention group (testing session 2). In the next four sessions (testing sessions 3-6), participants will receive 24 IU of intranasal OT 30 minutes before the start of the intervention. Sessions of the intervention will be conducted weekly. After completion of the intervention, participants will again undergo fMRI scanning (testing session 7). Three weeks and three months after completion of the intervention, follow-up measurements of the experienced loneliness and subjective well-being will be collected.
All fMRI testing sessions (1 and 7) will include following tasks:
- Blood-oxygen-level dependent (BOLD) signal will be measured while participants play a single-round trust game in the role of an investor. Participants will have to decide the amount of money they want to invest in an unknown trustee without receiving feedback about the decisions of the trustees. If the participant chooses to invest, that amount will be tripled and added to the trustee's account. The trustee may keep all of the money for him/herself or share the money with the investor. Participants will be informed of the collection of the trustee's decisions in a previous study for all possible investments. Furthermore, participants will view an image of a randomly chosen trustee from the previous study during the MRI session. In a control condition, participants will play a risk game and invest money in a computer (which will randomly decide whether the money will be shared).
- BOLD signal will be assessed while participants undergo a social touch task. Trials will include slow (~ 5 cm/s) and fast touch (~ 20 cm/s) across 20 cm of the shins as well as a control condition (no touch). The touch will be administered by an experimenter that cannot be seen by the participants. After each trial, participants will be asked to rate the perceived comfort of the stimulation.
- Conditions
- Loneliness
- Being tested
- Oxytocin nasal spray, Placebo
- Keywords
- loneliness, oxytocin-augmented intervention, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Intranasal administration of 24 international units oxytocin.
PlaceboDrug
The placebo nasal sprays contains identical ingredients except for the peptide itself.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin (24 IU) | Experimental | Intranasal administration of 24 international units (IU) of oxytocin (OT) 30 minutes before the start of four intervention sessions Receives: Drug: Oxytocin nasal spray |
| Placebo | Placebo comparator | Intranasal administration of a placebo spray 30 minutes before the start of four intervention sessions Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the UCLA Loneliness Scale
Loneliness, as measured via the University of California, Los Angeles (UCLA) loneliness scale before the start (testing session 1) and after completion of the intervention (testing session 7) (+ follow-up measurements 3 weeks and 3 months after completion of the intervention), will be analyzed using mixed ANOVAs with the software SPSS and Bonferroni-corrected post-hoc t-tests.
Measured: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
State loneliness (numeric rating scale)
State loneliness will be measured on a numeric rating scale ranging from 1 to 100 at the start and the end of each testing session and analyzed using mixed ANOVAs in SPSS and Bonferroni-corrected post-hoc t-tests.
Measured: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
Scores on the World Health Organization (WHO) Five Well-Being Index
Psychological well-being will be assessed using the World Health Organization (WHO) Five Well-Being Index before each testing session and analyzed using mixed ANOVAs in SPSS and Bonferroni-corrected post-hoc t-tests.
Measured: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
Scores on the Perceived Stress Scale
Perceived stress will be assessed using the Perceived Stress Scale (PSS-10) before each testing session and analyzed using mixed ANOVAs in SPSS and Bonferroni-corrected post-hoc t-tests.
Measured: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
Neural responses in the trust game
The BOLD signal as response to the trust game will be compared to the risk game and changes in the signal from testing session 1 to 7 will be compared between the OT and PLC groups. Results from both fMRI testing sessions will be compared to a non-lonely healthy control group (data were collected in a previous study with the same fMRI tasks in two fMRI sessions five to seven weeks apart from each other). Analyses will focus on anatomically defined regions of interests (ROIs) associated with trust (insula, amygdala, nucleus accumbens, and ventromedial prefrontal cortex). For analyses of fMRI data, standard procedures of the software SPM12 will be used. The family-wise error rate will be used to correct p-values for multiple comparisons and p < .05 will be considered significant. fMRI data will be correlated with behavioral data of the trust game and the UCLA Loneliness scores.
Measured: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
Amount of invested money in the trust game as an economic value of trust
Behavioral data of the trust game (invested money) will be analyzed using mixed ANOVAs in SPSS and compared between the OT and PLC groups. Post-hoc t-tests will be Bonferroni-corrected. Behavioral data will be correlated with fMRI data of the trust game and the UCLA Loneliness scores.
Measured: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
Neural responses to interpersonal touch
BOLD signals of slow touch trials will be contrasted with fast touch trials. Again, results of the OT group will be compared with the PLC group and results of lonely participants will be compared to the results of a non-lonely healthy control group. Analyses will focus on ROIs associated with the processing of social touch (amygdala, hippocampus, insula, and primary somatosensory cortex). For analyses of fMRI data, standard procedures of SPM12 will be used (preprocessing \& a two-stage approach based on the general linear model for statistical analyses). The family-wise error rate will be used to correct p-values for multiple comparisons and p < .05 will be considered significant. Post-hoc t-tests will be Bonferroni-corrected. fMRI data will be correlated with behavioral data of the touch task and the UCLA loneliness scores.
Measured: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
Comfort ratings of interpersonal touch in the fMRI task (visual analogue scale)
Behavioral data of the fMRI interpersonal touch task (comfort ratings on a visual analogue scale) will be analyzed using mixed ANOVAs in SPSS and compared between the OT and the PLC group. Post-hoc t-tests will be Bonferroni-corrected. Comfort ratings will be correlated with fMRI data of the interpersonal touch task and the UCLA loneliness scores.
Measured: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
Therapeutic relationship (positive bonding) measured by the Group Questionnaire (GQ-D)
The therapeutic relationship (positive bonding) will be measured after all intervention sessions using the Group Questionnaire (GQ-D; subscale Positive Bonding). OT effects will be analyzed by conducting mixed ANOVAs and Bonferroni-corrected post-hoc t-tests in SPSS.
Measured: Five weeks
Therapeutic relationship (positive working) measured by the Group Questionnaire (GQ-D)
The therapeutic relationship (positive working) will be measured after all intervention sessions using the GQ-D (subscale Positive Working). OT effects will be analyzed by conducting mixed ANOVAs and Bonferroni-corrected post-hoc t-tests in SPSS.
Measured: Five weeks
Therapeutic relationship (negative relationship) measured by the Group Questionnaire (GQ-D)
The therapeutic relationship (negative relationship) will be measured after all intervention sessions using the GQ-D (subscale Negative Relationship). OT effects will be analyzed by conducting mixed ANOVAs and Bonferroni-corrected post-hoc t-tests in SPSS.
Measured: Five weeks
Secondary outcomes (2)
Interpersonal distance
Interpersonal distance will be assessed by an adapted version of an established stop-distance paradigm. Participants start from a distance of ~ 2 m and move towards the investigator until their ideal distance is reached (trials 1 and 3) or until they feel slightly uncomfortable (trials 2 and 4). The task will be applied by the same investigator at testing sessions 1 and 7. Data will be analyzed using mixed ANOVAs and Bonferroni-corrected t-tests in SPSS to compare treatment group as well as lonely participants and non-lonely controls.
Measured: Five to seven weeks (before the start and after the completion of the intervention)
Neural activity at resting state
fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open. Participants will be instructed to look at a fixation cross for ~ 6 minutes. Functional connectivity will be analyzed using default preprocessing parameters implemented in the CONN-toolbox. Changes in functional connectivity will be contrasted between treatment groups and activity will be compared to those of non-lonely controls.
Measured: Five to seven weeks (fMRI task will be completed before start and after completion of the intervention and will take about 6 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start26 Sep 2019
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive either 24 IU of intranasal OT or placebo (PLC) over the four intervention sessions. All participants in one intervention group will receive the same substance.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- The German-Israeli Foundation for Scientific Research and Development, Prof. Simone Shamay-Tsoory, University of Haifa
- Responsible party
- Principal investigator, Rene Hurlemann, University of Oldenburg
- Investigators
- Rene Hurlemann, MSc, MD, PhD, Principal investigator, University of Oldenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137432
- Sponsor's protocol ID
- GIF2
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 24 Oct 2019
- 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 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention on Neural and Behavioral Correlates of Loneliness
- ClinicalTrials.gov ID
- NCT04137432
- Acronym / sponsor ID
- GIF2
- Conditions
- Loneliness
- Keywords
- loneliness, oxytocin-augmented intervention, fMRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- The German-Israeli Foundation for Scientific Research and Development, Prof. Simone Shamay-Tsoory, University of Haifa
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Oct 2019 (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 purpose of this study is to evaluate the clinical potential of oxytocin (OT) as an adjunct to a cognitive-behavioral group-based shortterm intervention for participants suffering from loneliness.
Detailed description
Loneliness has a high prevalence in Western societies and poses a significant health problem. Among its many implications, loneliness has been associated with increased risk for coronary heart disease and stroke, depression, cognitive decline, dementia, and mortality. At the neural level, several networks may be involved in loneliness, including the reward circuitry, which mediates social reward, and the amygdala, which signals social threat. Intranasal OT has been reported to regulate activity in both the reward system and the amygdala. Therefore, it may serve as an adjunct to a cognitive-behavioral short-term intervention for high lonely participants.
In this randomized, double-blind, placebo-controlled design study, effects of intranasal OT (24 international units (UI)) as a pharmacological augmentation given before the start of four sessions of a cognitive-behavioral short-term intervention in groups of six to eight participants (based on established interpersonal psychotherapy modules to reduce loneliness) will be investigated. Healthy, but high lonely participants will complete functional magnetic resonance imaging (fMRI) tasks in a separate testing session before the start of the intervention (testing session 1). In the first session of the intervention, the psychotherapist will inform the participants about the procedure of the intervention and participants will get to know the other participants in their intervention group (testing session 2). In the next four sessions (testing sessions 3-6), participants will receive 24 IU of intranasal OT 30 minutes before the start of the intervention. Sessions of the intervention will be conducted weekly. After completion of the intervention, participants will again undergo fMRI scanning (testing session 7). Three weeks and three months after completion of the intervention, follow-up measurements of the experienced loneliness and subjective well-being will be collected.
All fMRI testing sessions (1 and 7) will include following tasks:
- Blood-oxygen-level dependent (BOLD) signal will be measured while participants play a single-round trust game in the role of an investor. Participants will have to decide the amount of money they want to invest in an unknown trustee without receiving feedback about the decisions of the trustees. If the participant chooses to invest, that amount will be tripled and added to the trustee's account. The trustee may keep all of the money for him/herself or share the money with the investor. Participants will be informed of the collection of the trustee's decisions in a previous study for all possible investments. Furthermore, participants will view an image of a randomly chosen trustee from the previous study during the MRI session. In a control condition, participants will play a risk game and invest money in a computer (which will randomly decide whether the money will be shared).
- BOLD signal will be assessed while participants undergo a social touch task. Trials will include slow (~ 5 cm/s) and fast touch (~ 20 cm/s) across 20 cm of the shins as well as a control condition (no touch). The touch will be administered by an experimenter that cannot be seen by the participants. After each trial, participants will be asked to rate the perceived comfort of the stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will receive either 24 IU of intranasal OT or placebo (PLC) over the four intervention sessions. All participants in one intervention group will receive the same substance.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin (24 IU) | Experimental | Drug: Oxytocin nasal sprayIntranasal administration of 24 international units (IU) of oxytocin (OT) 30 minutes before the start of four intervention sessions |
| Placebo | Placebo comparator | Drug: PlaceboIntranasal administration of a placebo spray 30 minutes before the start of four intervention sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- UCLA loneliness scale score equal to or greater than 55
Key exclusion criteria (4 listed)
- current psychiatric illness
- current psychiatric medication or psychotherapy
- MRI contraindication (e.g. metal in body, claustrophobia)
- pregnancy
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 |
|---|---|---|
| Oxytocin nasal sprayIntranasal administration of 24 international units oxytocin. | Drug | Oxytocin (24 IU) |
| PlaceboThe placebo nasal sprays contains identical ingredients except for the peptide itself. | Drug | Placebo |
Primary outcome
Scores on the UCLA Loneliness Scale
Time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
Loneliness, as measured via the University of California, Los Angeles (UCLA) loneliness scale before the start (testing session 1) and after completion of the intervention (testing session 7) (+ follow-up measurements 3 weeks and 3 months after completion of the intervention), will be analyzed using mixed ANOVAs with the software SPSS and Bonferroni-corrected post-hoc t-tests.
State loneliness (numeric rating scale)
Time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
State loneliness will be measured on a numeric rating scale ranging from 1 to 100 at the start and the end of each testing session and analyzed using mixed ANOVAs in SPSS and Bonferroni-corrected post-hoc t-tests.
Scores on the World Health Organization (WHO) Five Well-Being Index
Time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
Psychological well-being will be assessed using the World Health Organization (WHO) Five Well-Being Index before each testing session and analyzed using mixed ANOVAs in SPSS and Bonferroni-corrected post-hoc t-tests.
Scores on the Perceived Stress Scale
Time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
Perceived stress will be assessed using the Perceived Stress Scale (PSS-10) before each testing session and analyzed using mixed ANOVAs in SPSS and Bonferroni-corrected post-hoc t-tests.
Neural responses in the trust game
Time frame: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
The BOLD signal as response to the trust game will be compared to the risk game and changes in the signal from testing session 1 to 7 will be compared between the OT and PLC groups. Results from both fMRI testing sessions will be compared to a non-lonely healthy control group (data were collected in a previous study with the same fMRI tasks in two fMRI sessions five to seven weeks apart from each other). Analyses will focus on anatomically defined regions of interests (ROIs) associated with trust (insula, amygdala, nucleus accumbens, and ventromedial prefrontal cortex). For analyses of fMRI data, standard procedures of the software SPM12 will be used. The family-wise error rate will be used to correct p-values for multiple comparisons and p < .05 will be considered significant. fMRI data will be correlated with behavioral data of the trust game and the UCLA Loneliness scores.
Amount of invested money in the trust game as an economic value of trust
Time frame: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
Behavioral data of the trust game (invested money) will be analyzed using mixed ANOVAs in SPSS and compared between the OT and PLC groups. Post-hoc t-tests will be Bonferroni-corrected. Behavioral data will be correlated with fMRI data of the trust game and the UCLA Loneliness scores.
Neural responses to interpersonal touch
Time frame: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
BOLD signals of slow touch trials will be contrasted with fast touch trials. Again, results of the OT group will be compared with the PLC group and results of lonely participants will be compared to the results of a non-lonely healthy control group. Analyses will focus on ROIs associated with the processing of social touch (amygdala, hippocampus, insula, and primary somatosensory cortex). For analyses of fMRI data, standard procedures of SPM12 will be used (preprocessing \& a two-stage approach based on the general linear model for statistical analyses). The family-wise error rate will be used to correct p-values for multiple comparisons and p < .05 will be considered significant. Post-hoc t-tests will be Bonferroni-corrected. fMRI data will be correlated with behavioral data of the touch task and the UCLA loneliness scores.
Comfort ratings of interpersonal touch in the fMRI task (visual analogue scale)
Time frame: Five to seven weeks (fMRI task will be completed before the start and after the completion of the intervention and will take about 15 minutes)
Behavioral data of the fMRI interpersonal touch task (comfort ratings on a visual analogue scale) will be analyzed using mixed ANOVAs in SPSS and compared between the OT and the PLC group. Post-hoc t-tests will be Bonferroni-corrected. Comfort ratings will be correlated with fMRI data of the interpersonal touch task and the UCLA loneliness scores.
Therapeutic relationship (positive bonding) measured by the Group Questionnaire (GQ-D)
Time frame: Five weeks
The therapeutic relationship (positive bonding) will be measured after all intervention sessions using the Group Questionnaire (GQ-D; subscale Positive Bonding). OT effects will be analyzed by conducting mixed ANOVAs and Bonferroni-corrected post-hoc t-tests in SPSS.
Therapeutic relationship (positive working) measured by the Group Questionnaire (GQ-D)
Time frame: Five weeks
The therapeutic relationship (positive working) will be measured after all intervention sessions using the GQ-D (subscale Positive Working). OT effects will be analyzed by conducting mixed ANOVAs and Bonferroni-corrected post-hoc t-tests in SPSS.
Therapeutic relationship (negative relationship) measured by the Group Questionnaire (GQ-D)
Time frame: Five weeks
The therapeutic relationship (negative relationship) will be measured after all intervention sessions using the GQ-D (subscale Negative Relationship). OT effects will be analyzed by conducting mixed ANOVAs and Bonferroni-corrected post-hoc t-tests in SPSS.
2 secondary outcomes
Interpersonal distance
Time frame: Five to seven weeks (before the start and after the completion of the intervention)
Neural activity at resting state
Time frame: Five to seven weeks (fMRI task will be completed before start and after completion of the intervention and will take about 6 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Neuromodulation of Emotion (NEMO) research groupLink 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.
Rene Hurlemann, MSc, MD, PhD principal investigator
University of Oldenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin nasal spray in people with Loneliness, run by University Hospital, Bonn 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Oct 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Scores on the UCLA Loneliness Scale (time frame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)). The study lists 11 primary outcomes in all. 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 24 Oct 2019.