Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders



Status:Completed
Conditions:Insomnia Sleep Studies, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:60 - Any
Updated:10/14/2017
Start Date:April 2007
End Date:March 2008

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The purpose of this pilot study is to assess feasibility and patient accessibility in order
to design an adequately powered study to compare group cognitive behavioral therapy for
insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with
controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual
insomnia.


Inclusion Criteria:

1. Age greater or equal to 60 years.

2. Patients with history of major affective disorder, including Bipolar disorder type I
or type II or major depressive disorder, as assessed by the Structured Clinical
Interview for DSM-IV (SCID), currently in remission.

3. Difficulty starting or initiating sleep four or more times/week for at least 3 months
by history.

4. Total Pittsburg Sleep Quality Index >5.

Exclusion Criteria:

1. Patient in an acute mood episode as assessed by SCID

2. Patients with sleep disruptive medical problems including: sleep apnea, restless leg
syndrome, periodic limb movement, parasomnia, congestive heart failure, chronic pain
and chronic obstructive pulmonary disease as assessed by medical history and medical
record review.

3. Patients with schizophrenia, primary anxiety disorder and active substance abuse as
determined by SCID.

4. Patients on or with history of failure or intolerance to respond to quetiapine.

5. Patient with positive Alcohol Use Disorders Identification Test (AUDIT) with a total
score above 8.

6. Patients with dementia brain degenerative diseases, cognitive disorders and Mini
Mental Status Examination (MMSE) score of less or equal to 24.

7. Patients who are in an acute depressive, manic, hypomanic or mixed state as reflected
by SCID

8. Patients on concurrent sedating medications that would confound interpretation of the
results. This is operationalized as follow: Sedating medications must be present and
stable dosage for at least 14 days prior to enrollment in the study. If the medication
is not prescribed as a primary sleep aid, it will be continued. Our rationale is that
patients may need these medications and the initial sedating effect will have
plateaued by 14 days. However, medications prescribed to assist insomnia will be
discontinued as they are not effective for the subjects who otherwise meet inclusion
ad exclusion criteria for the current study. Medications will be tapered as clinically
indicated after the patients sing informed consent and prior to baseline assessment.
We found this trial at
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Houston, Texas 77030
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Houston, TX
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