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

NCT ID: NCT04137432

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2020-12-31

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.

Conditions

Loneliness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Oxytocin (24 IU)

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Intranasal administration of 24 international units oxytocin.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Oxytocin nasal spray

Intranasal administration of 24 international units oxytocin.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The German-Israeli Foundation for Scientific Research and Development

OTHER

Sponsor Role: collaborator

Prof. Simone Shamay-Tsoory, University of Haifa

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Rene Hurlemann

Professor for Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rene Hurlemann, MSc, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oldenburg

Locations

Department of Psychiatry, University of Bonn

Bonn, , Germany

Countries

Germany

Related Links

http://renehurlemann.squarespace.com/welcome/

Neuromodulation of Emotion (NEMO) research group

Other Identifiers

GIF2

Identifier Type: -

Identifier Source: org_study_id