CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Chronic Insomnia; Cancer

Treatments: Behavioral: cognitive behavioral therapy for insomnia (CBTI); Behavioral: Waitlist control condition

Study type: Interventional

Funder types: Other

Identifiers

NCT02410564

HM20002827

MCC-14-10761

Details and patient eligibility

About

To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients.

Full description

The proposed study will be a randomized controlled trial design. Participants will be randomized to either a CBTI treatment or a wait list control condition. The intervention is SHUTi, a validated web based version of CBTI, which will take place over seven weeks and will include a combination of face to face and telephone sessions, and email updates. All participants will have a face to face meeting with the doctoral student at enrollment. During the intervention period, all participants will be contacted by telephone at week 1, 3, and 6 to check in and to encourage participant engagement. However, during phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study. Participants in SHUTi will additionally be provided the the doctoral student's phone number and will be encouraged to contact her if they have any questions during the intervention. They will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance. Pretreatment, all participants will complete a two week sleep diary and multiple self report measures. At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed with I-III non-metastatic cancer
• scheduled to begin chemotherapy or radiotherapy
• chemotherapy or radiotherapynaïve
• meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
• Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
• interested in behavioral sleep treatment
• have the permission of their oncologists to participate.

Exclusion criteria

• untreated alcohol or substance abuse or dependence, bipolar, or psychotic disorder
• medical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
• untreated sleep disorders such as sleep apnea

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups, including a placebo group

CBTI treatment

Active Comparator group

Description:

cognitive behavioral therapy for insomnia (CBTI) treatment is a validated web based version of CBT-I, which will take place over seven weeks and will include a combination of face-to-face and telephone sessions, and email updates

Treatment:

Behavioral: cognitive behavioral therapy for insomnia (CBTI)

Waitlist control condition

Placebo Comparator group

Description:

No advice regarding sleep will be given to the control group and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.

Treatment:

Behavioral: Waitlist control condition