Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life (Seteb)

IRCCS San Camillo, Venezia, Italy

Status: Enrolling

Conditions: Spinal Cord Injuries; Multiple Sclerosis

Treatments: Behavioral: Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05142111

2020.12

Details and patient eligibility

About

In this study patients with Multiple Sclerosis or Spinal Lesions will participate in two different types of treatments that aim to improve sexual and sentimental life. Behavioral (via questionnaires) and brain (via high-density electroencephalogram) effects associated with treatment will be studied.

Full description

People with neurological diseases can experience sexual disorders that can affect their quality of life. There are cognitive treatments to improve these aspects, but their effectiveness is not clear. The aim of this study is to test the potential efficacy of two treatments (mindfulness and sezual therapy) in two neurological populations (patients with multiple sclerosis and patients with spinal injury). To verify the effects of the treatment, questionnaires and brain activity measurements, measured by electroencephalogram, will be used.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• medical diagnosis of MS or spinal injury.
• ability to sign informed consent.

Exclusion criteria

• other relevant previous neurological or psychiatric pathologies.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Sexual therapy

Experimental group

Description:

In the sessions a series of questions will be proposed to the subject, who will be free to answer or not, being able to express questions in turn. The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.

Treatment:

Behavioral: Therapy

Mindfulness

Active Comparator group

Description:

During the mindfulness treatment the subjects will be subjected to sessions in which they will be invited to relax, to become aware of the present moment, of their body, through exercises that involve breathing, attention, and visualization of the body. The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.

Treatment:

Behavioral: Therapy