The purpose of the study was to compare the effects
of psychotherapy, nefazodone, and their combination on subjective measures
of sleep in patients with chronic forms of major depression.
Participants were randomized to receive 12 weeks of treatment
with one of the three interventions.
The study was conducted in parallel at 12 academic institutions
and was approved by the Human Subjects Committee at each site.
484 adult outpatients (65.29% female) who met DSM-IV criteria
for one of three chronic forms of major depression.
Psychotherapy (16-20 sessions) was provided by certified
therapists following a standardized treatment manual for Cognitive Behavioral
Analysis System of Psychotherapy (CBASP), a variant of cognitive
psychotherapy developed for chronic depression. Pharmacotherapy consisted
of open-label nefazodone, 300–600 mg per day in two divided
doses prescribed by psychiatrists. The clinical management visits were
limited to 15-20 minutes and followed a standardized protocol. Combination
treatment consisted of both therapies.
Measurements and Results:
Depression outcome was determined by
the 24-item Hamilton Rating Scale for Depression and the 30-item Inventory
of Depressive Symptomatology-Self Rating. Sleep outcome was
measured prospectively with daily sleep diaries that were completed a
week prior to HRSD assessments at baseline and after 1, 2, 3, 4, 8, and
12 weeks of treatment. Although nefazodone alone and CBASP alone
had comparable impact on global measures of depression outcome, only
monotherapy with nefazodone improved early morning awakening and
total sleep time. Significant improvements in sleep quality, time awake
after sleep onset, latency to sleep onset, and sleep efficiency were present
in each of the three treatment groups. These improvements, however,
occurred earlier in the course of treatment for participants receiving
nefazodone, alone or in combination with CBASP.
Nefazodone therapy may have a direct impact on disturbed
sleep associated with depression beyond what would be expected
if the improvements were all a consequence of improved depression.