Reduce Emotional Symptoms of Insomnia With SleepTreatment (RESIST)

Henry Ford Health

Status: Completed

Conditions: Insomnia; Rumination

Treatments: Behavioral: Mindfulness-Based Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT03724305

RESIST

Details and patient eligibility

About

The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.

Full description

Cognitive-behavioral therapy and pharmacotherapy are effective interventions for insomnia. Even so, about half of patients do not adequately respond to these treatments. Non-remission has been linked to high cognitive arousal that does not improve with traditional therapies. This study will examine the effects of mindfulness-based therapy for insomnia (MBTI) in a sample of patients who previously failed cognitive behavioral therapy and/or pharmacotherapy for insomnia.

This trial utilizes a single-arm, open label trial of MBTI. MBTI is delivered via telemedicine video in an individual therapy format.

Male and female participants who have insomnia, are age 18 and older, and who are recruited into the study will complete an initial assessment of their qualifications that are based on the severity of their insomnia symptoms, depression symptoms, and physical and mental health status. Eligible participants will undergo a clinical sleep interview and then complete 8 sessions of MBTI. Study outcomes are assessed via online survey before treatment, after treatment, and then a 6-month follow-up.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Determination of insomnia (ISI>10)
• Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.

Exclusion criteria

• Age < 18
• Current use of antidepressants for depression
• Bipolar or Seizure disorders
• Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

MBTI

Experimental group

Description:

Mindfulness-Based Therapy for Insomnia

Treatment:

Behavioral: Mindfulness-Based Therapy for Insomnia