Clinical trial NCT04137432: Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention for Loneliness
Official title: Effects of an Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention on Neural and Behavioral Correlates of Loneliness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Loneliness
Keywords: loneliness
oxytocin-augmented intervention
fMRI
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: The German-Israeli Foundation for Scientific Research and Development
name: Prof. Simone Shamay-Tsoory, University of Haifa
First posted: 2019-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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:

1. 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).
2. 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.

Eligibility criteria: Inclusion Criteria:

* UCLA loneliness scale score equal to or greater than 55

Exclusion Criteria:

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

Primary outcomes:
measure: Scores on the UCLA Loneliness Scale
timeFrame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
measure: State loneliness (numeric rating scale)
timeFrame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
measure: Scores on the World Health Organization (WHO) Five Well-Being Index
timeFrame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
measure: Scores on the Perceived Stress Scale
timeFrame: Five to seven weeks (+ Follow-Up measurements 3 weeks and 3 months after completion of the intervention)
measure: Neural responses in the trust game
timeFrame: 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)
measure: Amount of invested money in the trust game as an economic value of trust
timeFrame: 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)
measure: Neural responses to interpersonal touch
timeFrame: 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)
measure: Comfort ratings of interpersonal touch in the fMRI task (visual analogue scale)
timeFrame: 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)
measure: Therapeutic relationship (positive bonding) measured by the Group Questionnaire (GQ-D)
timeFrame: Five weeks
measure: Therapeutic relationship (positive working) measured by the Group Questionnaire (GQ-D)
timeFrame: Five weeks
measure: Therapeutic relationship (negative relationship) measured by the Group Questionnaire (GQ-D)
timeFrame: Five weeks
Secondary outcomes:
measure: Interpersonal distance
timeFrame: Five to seven weeks (before the start and after the completion of the intervention)
measure: Neural activity at resting state
timeFrame: 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:
measure: Oxytocin plasma concentrations
timeFrame: Five to seven weeks (before the start and after the completion of the intervention)
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
affiliation: University of Oldenburg
name: Rene Hurlemann, MSc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: