The Role of Partial Reinforcement in the Long Term Management of Insomnia
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | July 2006 |
| End Date: | June 2013 |
The lack of scientific attention devoted to the placebo effect as a phenomenon in its own
right probably reflects the paucity of theoretical positions within which to organize the
existing data and design new research. The proposed investigation 1) is an attempt to
advance from a descriptive to an experimental analysis of the placebo effect, taking into
account classical conditioning effects, and 2) examines the clinical implications of partial
reinforcement as it is applied to the treatment of insomnia. Subjects with primary insomnia
will be treated with zolpidem for a period of one month and then randomized to one of four
groups for a period of 12 weeks: one receiving full dose zolpidem on a nightly basis
(continuous reinforcement), one receiving full dose zolpidem on 14 of 28 nights where
placebo is provided on non-drug nights (partial reinforcement), one receiving full dose
zolpidem on 14 of 28 nights where no pills are imbibed on non-drug nights (intermittent
dosing), and one receiving 5 mg dose zolpidem on a nightly basis (continuous reinforcement
with half the standard dose). Following treatment, subjects will be entered into an
extinction protocol during which they will 1) continue on the schedule assigned during the
experimental period, 2) receive only placebo, or 3) receive neither drug nor placebo. Sleep
and daily functioning will be monitored on a daily basis via sleep diaries for the duration
of the study. It is hypothesized that, holding cumulative dose constant, a partial schedule
of reinforcement will enable patients to better maintain their clinical gains as compared to
subjects that receive either continuous reinforcement with half the standard dose or half
the frequency of use.
Relevance: The proposed research is not an attempt to offer a behavioral alternative to drug
treatment; it is an attempt to acknowledge and capitalize on a behavioral dimension in the
design of drug treatment protocols. The value of the proposed research resides in its
capacity to provide for the long term treatment of insomnia in a manner that increases the
durability of pharmacotherapy while reducing the overall amount of medication required. If
proven effective in the current application, this new approach to pharmacotherapy and
placebo effects is likely to stimulate new interdisciplinary research for the treatment of a
variety of chronic diseases.
right probably reflects the paucity of theoretical positions within which to organize the
existing data and design new research. The proposed investigation 1) is an attempt to
advance from a descriptive to an experimental analysis of the placebo effect, taking into
account classical conditioning effects, and 2) examines the clinical implications of partial
reinforcement as it is applied to the treatment of insomnia. Subjects with primary insomnia
will be treated with zolpidem for a period of one month and then randomized to one of four
groups for a period of 12 weeks: one receiving full dose zolpidem on a nightly basis
(continuous reinforcement), one receiving full dose zolpidem on 14 of 28 nights where
placebo is provided on non-drug nights (partial reinforcement), one receiving full dose
zolpidem on 14 of 28 nights where no pills are imbibed on non-drug nights (intermittent
dosing), and one receiving 5 mg dose zolpidem on a nightly basis (continuous reinforcement
with half the standard dose). Following treatment, subjects will be entered into an
extinction protocol during which they will 1) continue on the schedule assigned during the
experimental period, 2) receive only placebo, or 3) receive neither drug nor placebo. Sleep
and daily functioning will be monitored on a daily basis via sleep diaries for the duration
of the study. It is hypothesized that, holding cumulative dose constant, a partial schedule
of reinforcement will enable patients to better maintain their clinical gains as compared to
subjects that receive either continuous reinforcement with half the standard dose or half
the frequency of use.
Relevance: The proposed research is not an attempt to offer a behavioral alternative to drug
treatment; it is an attempt to acknowledge and capitalize on a behavioral dimension in the
design of drug treatment protocols. The value of the proposed research resides in its
capacity to provide for the long term treatment of insomnia in a manner that increases the
durability of pharmacotherapy while reducing the overall amount of medication required. If
proven effective in the current application, this new approach to pharmacotherapy and
placebo effects is likely to stimulate new interdisciplinary research for the treatment of a
variety of chronic diseases.
Inclusion Criteria:
- Patients with insomnia will meet RDC criteria for psychophysiologic insomnia(99).
These criteria are provided in Appendix 2. In addition, the complaint of disturbed
sleep will have one or more of the following characteristics:
- > 30 minutes to fall asleep (Initial Insomnia)
- 2 awakenings per night of >15 minutes duration and/or wake after sleep onset
time of > 30 minutes (Middle Insomnia)
- An awakening of > 30 minutes prior to the desired "wake up" time (Late Insomnia)
- Any two of the above complaints (Mixed Insomnia)
Additionally, total sleep time will not exceed 6 hours (unless the sleep efficiency
quotient is < 80%) and the problem frequency must be equal to or greater than 4 nights/
week (severe insomnia) with a problem duration > 6 months (chronic insomnia). This profile
must be evident at both intake (based on retrospective reports) and as an average profile
from the two weeks of baseline diaries (based on prospective sampling).
Exclusion Criteria:
- Unstable medical or psychiatric illness Assessed with the Mini International
Neuropsychiatric Interview (MINI) and the The Schedule for Affective Disorders and
Schizophrenia-Lifetime Version (SADS-L) To assure that the insomnia is not secondary
to these factors
- Symptoms suggestive of sleep disorders other than insomnia Assessed with the SDS-CL
To assure that the insomnia is not secondary to these factors
- Polysomnographic data indicating sleep disorders other than insomnia Assessed with
PSG in collaboration with our sleep medicine consultants To assure that the insomnia
is not secondary to these factors
- History of head injury with a sustained loss of consciousness Assessed by self report
during the Intake Interview To help assure that the EEG measures are unconfounded by
brain damage
- Evidence of active illicit substance use or fitting criteria for alcohol abuse or
dependence Assessed with a structured psychiatric interview schedule (the MINI) ,
written versions of clinical interview queries regarding alcohol use, abuse and
dependence (the AUDIT and CAGE), the toxicology screen which is part of the clinical
chemistries obtained during the screening physical. To assure that the insomnia is
not secondary to these factors and to assure that substance use/abuse does not
confound treatment.
- Use of CNS active medications, antidepressants, and hypnotics other than zolpidem
Assessed by self report and from the toxicology screen which is part of the clinical
chemistries obtained during the screening physical. To help assure that the clinical
effects observed in this study are due to the study medication and schedule of
reinforcement.
- Inadequate language comprehension Informally, assessed by the Clinical Research
Coordinator during Intake Interview To assure the quality of self report data as all
the measures are in English.
- Pregnancy Assessed by self report and from the clinical chemistries data obtained
during the screening physical. Excluded so as to 1) prevent the fetus from exposure
to the study medication (although it should be noted that the medication is
considered FDA pregnancy category B) and 2) control for the biopsychosocial changes
that occur with pregnancy and may alter the response to the study medication and
schedule of reinforcement.
- No first-degree relatives with bipolar disorder or schizophrenia Assessed by self
report and a structured psychiatric interview schedule (the SADs). Excluded to reduce
risk for first onset during the study
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