Impact of Cognitive Behavioral Therapy on Parasomnias

NCT04633668 | Completed

• 1 other identifier: Umanitoba1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities).

Conditions

Parasomnia

Outcome Measures

Primary Outcomes (3)

• Parasomnia events

  \# of parasomnia events

  6 weeks

• Nocturnal Activity

  activity level during sleep period

  6 weeks

• Nightmares

  Nightmare Experiences Scale, 0-16, higher scores more problematic nightmares

  6 weeks

Secondary Outcomes (6)

• Fatigue

  6 weeks

• Sleepiness

  6 weeks

• Insomnia

  6 weeks

• Cognitive

  6 weeks

• Impairment

  6 weeks

Study Arms (2)

CBT-p

EXPERIMENTAL

cognitive behavioral therapy, Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy

Behavioral: CBT for parasomnias (CBT-p)

Self-monitoring

ACTIVE COMPARATOR

Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy

Behavioral: Self-Monitoring

Interventions

CBT for parasomnias (CBT-p) BEHAVIORAL

Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks

CBT-p

Self-Monitoring BEHAVIORAL

Monitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks

Self-monitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM 5 Parasomnia Disorder
• at least one parasomnia event per week
• daytime fatigue or sleepiness
• months in duration

You may not qualify if:

• current use of agents known to triggers parasomnias such as Lithium carbonate, Thioridazine, Chlorpromazine, Perhphenazine, Methaqualone, or Amitriptyline,
• for participants taking benzodiazepines or Prazosin, a stable dose regime for the past 4 weeks,
• excessive alcohol consumption defined as the consumption of \> 10 alcoholic beverages per week

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Psychealth Center, 771 Bannatyne Avenue

Winnipeg, Manitoba, R3E 3N4, Canada

Location

Related Publications (1)

• Vincent N, Dirkse D, Giannouli E, McQuarrie A. Transdiagnostic cognitive behavioral therapy for nightmares and parasomnias. J Clin Sleep Med. 2023 Mar 1;19(3):499-509. doi: 10.5664/jcsm.10374.

  PMID: 36468650 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Shelley Rempel-Rossum

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Self-Monitoring of sleep
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist/Professor

Model Details: 2 (group) X 3 (time)

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 18, 2020
• Study Start: January 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)