CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients



Status:Terminated
Conditions:Cancer, Cancer, Insomnia Sleep Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2014
End Date:January 2016

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Testing an Accessible Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention in Newly Diagnosed Cancer Patients

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.

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.

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
We found this trial at
1
site
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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from
Richmond, VA
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