Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)
14 agosto 2026 aggiornato da: University of Kansas Medical Center
Feasibility, Acceptability, and Preliminary Treatment Efficacy of Early Cognitive Behavioral Therapy for Insomnia (CBT-I) to Mitigate Insomnia Symptoms and Fatigue and Improve Health-related Quality of Life in Individuals Planning to Undergo Hematopoietic Stem Cell Transplant (HSCT)
This proposed study is a prospective, randomized, controlled Phase 1 clinical trial to determine feasibility, acceptability (Aim 1) and preliminary effect (Aim 2) to mitigate insomnia symptoms and fatigue and improve health-related quality of life in patients who are planning to undergo HSCT.
The investigators plan to enroll n=30 with insomnia symptoms (Insomnia Severity Index ≥10) who will be randomized into one of two groups: 1.
A group that starts CBT-I after the initial evaluation visit with the HSCT care team (Early CBT-I), or 2. Treatment as usual (TAU).
Participants in the CBT-I group will receive six sessions of telehealth-delivered CBT-I that is completed prior to transplant.
Reassessments will occur post-intervention (~1-2 weeks before HSCT) and 1- and 3-months post-HSCT.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Catherine Siengsukon, PT, PHD
- Numero di telefono: 913-588-6913
- Email: csiengsukon@kumc.edu
Backup dei contatti dello studio
- Nome: Jade Robichaud
- Email: jrobichaud@kumc.edu
Luoghi di studio
-
-
Kansas
-
Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
-
Contatto:
- Jade Robichaud
- Email: jrobichaud@kumc.edu
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- ≥18 years old
- ≥10 on Insomnia Severity Index
- Primary HSCT physician approval
- English speaking
Exclusion Criteria:
- Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
- >3 on STOP BANG indicating increased risk of sleep apnea
- Increased risk of Restless legs syndrome as determined by RLS-Diagnosis Index
- Parasomnia as determined by the Sleep Disorders-Revised
- If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking < 3 months or dose has changed in past 3 months
- T-score ≥70 on PROMIS 29+2 Anxiety or PROMIS 29+2 Depression domains indicating moderate/severe anxiety or depression
- Current or history (up to 2 years) of substance use disorder involving drugs or alcohol as defined by DSM-5-TR criteria
- History of other nervous system disorder such as stroke or Parkinson's disease
- Severe mental illness such as schizophrenia or bipolar disorder
- Severe neurological or sensory impairments that would interfere significantly with testing
- History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
- Currently receiving a behavioral sleep health intervention or other behavioral health interventions that may impact sleep (such as exercise, mindfulness, CBT)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Terapia cognitivo comportamentale per l'insonnia (CBT-I)
|
The CBT-I program is a 1x/week, 6-week one-one-one program via video conferencing with trained research personnel.
The program is based on standard CBT-I manuals.
|
|
Nessun intervento: Treatment As Usual (TAU)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recruitment
Lasso di tempo: 1 year
|
number of people enrolled out of the number of people eligible
|
1 year
|
|
Retention
Lasso di tempo: 1 year
|
number of participants who complete the study
|
1 year
|
|
Attendance
Lasso di tempo: pre-hematopoietic stem cell transplant (HSCT) reassessment
|
number of cognitive behavioral therapy for insomnia (CBT-I) sessions attended
|
pre-hematopoietic stem cell transplant (HSCT) reassessment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adherence
Lasso di tempo: pre-HSCT reassessment
|
% days/week performed stimulus control or counter control if unable to sleep within 20 minutes and % nights/week conducted wind-down routine
|
pre-HSCT reassessment
|
|
Acceptability of Intervention Measure (AIM)
Lasso di tempo: pre-HSCT reassessment
|
The AIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater acceptability.
|
pre-HSCT reassessment
|
|
Feasibility of Intervention Measure (FIM)
Lasso di tempo: pre-HSCT reassessment
|
The FIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater feasibility.
|
pre-HSCT reassessment
|
|
Intervention Appropriateness Measure (IAM)
Lasso di tempo: pre-HSCT reassessment
|
The IAM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater appropriateness.
|
pre-HSCT reassessment
|
|
Insomnia Severity Index (ISI)
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
The ISI consists of 7 items with score ranging from 0-28.
A higher score indicates higher insomnia severity
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
PROMIS Sleep-Related Impairment Short Form 8a
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Consists of 8 items, which are summed and converted to a T-score.
A higher scores indicates greater sleep-related impairment.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
Actigraph total sleep time
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Total sleep time will be determined using ActiLife software from time to fall asleep to time to wake up and will be reported in minutes.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
Actigraph sleep efficiency
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Sleep efficiency will be determined using ActiLife software and calculated as total sleep time divided by time in bed X 100 and will be reported in percent.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
Actigraph wake after sleep onset
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Wake after sleep onset will be determined using ActiLife software and calculated number of minutes determine be awake during the sleep period and will be reported in percent.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
The PROMIS 29+2
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
31-item self-report measure.
Scores are reported as standardized PROMIS T-scores, with higher scores indicating more of the domain being assessed.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sleep Self-Efficacy Scale (SESS)
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
SESS is a 9-item self-report questionnaire used to measure sleep self-efficacy.
The respondents indicate confidence in ability to accomplish 9 sleep behaviors on a 5-point Likert scale with 1 = "not confident" at all to 5 = "very confident".
The score ranges from 0 to 45 with a higher score indicating greater sleep self-efficacy.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
PROMIS Cognitive Function 8-item short form
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
8 items, each scored from 1-5.
The raw score is converted to a t-score, with higher scores indicating better perceived cognitive function.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
Positive Affect and Negative Affect Schedule (PANAS)
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
The 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 indicates greater intensity of negative emotions.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
Dysfunctional Beliefs About Sleep (DBAS)
Lasso di tempo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
This assessment is a 10 item Likert-scale self-report questionnaire.
Higher scores indicate more dysfunctional beliefs.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
8 settembre 2026
Completamento primario (Stimato)
30 giugno 2027
Completamento dello studio (Stimato)
30 giugno 2027
Date di iscrizione allo studio
Primo inviato
11 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 agosto 2026
Primo Inserito (Effettivo)
19 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00162729
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .