Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention for Loneliness

NCT04137432 | Unknown Phase 1

• 1 other identifier: GIF2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Loneliness

Keywords

loneliness; oxytocin-augmented intervention; fMRI

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Five weeks

Secondary Outcomes (2)

• Interpersonal distance

  Five to seven weeks (before the start and after the completion of the intervention)

• Neural activity at resting state

  Five to seven weeks (fMRI task will be completed before start and after completion of the intervention and will take about 6 minutes)

Other Outcomes (1)

• Oxytocin plasma concentrations

  Five to seven weeks (before the start and after the completion of the intervention)

Study Arms (2)

Oxytocin (24 IU)

EXPERIMENTAL

Intranasal administration of 24 international units (IU) of oxytocin (OT) 30 minutes before the start of four intervention sessions

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

Intranasal administration of a placebo spray 30 minutes before the start of four intervention sessions

Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

Intranasal administration of 24 international units oxytocin.

Oxytocin (24 IU)

Placebo DRUG

The placebo nasal sprays contains identical ingredients except for the peptide itself.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• UCLA loneliness scale score equal to or greater than 55

You may not qualify if:

• current psychiatric illness
• current psychiatric medication or psychotherapy
• MRI contraindication (e.g. metal in body, claustrophobia)
• pregnancy

Sponsors & Collaborators

• University Hospital, Bonn: lead
• The German-Israeli Foundation for Scientific Research and Development: collaborator
• Prof. Simone Shamay-Tsoory, University of Haifa: collaborator

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Location

Related Links

• Neuromodulation of Emotion (NEMO) research group

Study Officials

• Rene Hurlemann, MSc, MD, PhD

  University of Oldenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 24, 2019
• Study Start: September 26, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)