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Università del KansasEfficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis (CALM)
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La sperimentazione clinica NCT06428006 (CALM) è uno studio interventistico di Fase II volto a esaminare il trattamento per Sclerosi multipla, Insonnia, attualmente in arruolamento. Avviato il 30 luglio 2024, prevede di arruolare 70 partecipanti. Sotto la guida di l'Università del Kansas, dovrebbe concludersi entro il 31 maggio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 luglio 2025.
Sommario breve
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).
Titolo ufficiale
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
Condizioni
Sclerosi multiplaInsonniaAltri ID dello studio
- CALM
- STUDY00160476
Numero NCT
Data di inizio (effettiva)
2024-07-30
Ultimo aggiornamento pubblicato
2025-07-20
Data di completamento (stimata)
2027-05-31
Arruolamento (previsto)
70
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Parole chiave
Cognitive behavioral therapy for insomnia
CBT-I
CBT-I
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleCognitive behavioral therapy for insomnia 1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education. | Terapia cognitivo-comportamentale per l'insonnia The general sessions outlines are as follows with each session:
Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention |
Comparatore attivoSleep and lifestyle education 1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education. | Sleep and Lifestyle Education The general sessions outlines are as follows with each session:
Session 1: Basic sleep education, stretching exercises Session 2: Sleep hygiene education (environmental factors \& sleep positions), stretching exercises Session 3: Sleep hygiene education (lifestyle factors), stretching exercises Session 4: Diet recommendations, stretching exercises Session 5: Exercises recommendations, stretching exercises Session 6: Discus maintaining achievements \& preventing relapses, stretching exercises |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Insomnia Severity Index (ISI) | The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia. | baseline, Week 6, Month 6 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Pittsburgh Sleep Quality Index (PSQI) | The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of \>5 reflects poor sleep quality. | baseline, Week 6, Month 6 |
Epworth Sleepiness Scale (ESS) | Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness. | baseline, Week 6, Month 6 |
Dysfunctional Beliefs About Sleep | This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs. | baseline, Week 6, Month 6 |
Positive Affect and Negative Affect Schedule (PANAS) | is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicate greater intensity of negative emotions. | baseline, Week 6, Month 6 |
Sleep Self-Efficacy Scale (SESS) | Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy. | baseline, Week 6, Month 6 |
Actigraphy | Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration | baseline, Week 6, Month 6 |
Modified Fatigue Impact Scale (MFIS) | The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue. | baseline, Week 6, Month 6 |
Fatigue Severity Scale (FSS) | The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7. | baseline, Week 6, Month 6 |
Multiple Sclerosis Impact Scale (MSIS-29) | Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS | baseline, Week 6, Month 6 |
Cognitive Failures Questionnaire (CFQ) | Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities. | baseline, Week 6, Month 6 |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 18-65 years old
- Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist
- Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
- Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
- ≥10 on Insomnia Severity Index
- English speaking
- ≥31 on modified Telephone Interview of Cognitive Status23
- Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
- Report having access to internet service or a data plan and access to a computer, tablet, or smart phone
- Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
- >3 on STOP BANG indicating increased risk of sleep apnea
- Restless legs syndrome as determined by RLS-Diagnosis Index
- Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
- Parasomnia as determined by the Sleep Disorders-Revised
- Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
- Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
- Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
- History of other nervous system disorder such as stroke or Parkinson's disease
- Currently pregnant or intending to become pregnant in the next 6 months
- Severe mental illness such as schizophrenia or bipolar disorder
- Severe neurological or sensory impairments that would interfere significantly with testing
- Relapse and/or corticosteroid use in the past 8 weeks
- History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
- Currently receiving a behavioral sleep health intervention
Università del Kansas229 studi clinici attivi da esplorareParte responsabile dello studio
Catherine Siengsukon, PT, PhD, Investigatore principale, Professor, University of Kansas Medical Center
Contatti principali dello studio
Contatto: Eryen Nelson, MPH, 913-945-7349, [email protected]
Contatto: Catherine Siengsukon, PhD, 913-588-6913, [email protected]
1 Centri dello studio in 1 paesi
Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States
In arruolamento