Will a sleep training consisting of CBT in a chronic, psychiatric population with depressive disorder and insomnia lead to a decline of sleeping problems and a increase in sleep quality? Will the results from a normal and non chronic population will…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters are the amount of sleep complaints and the quality of sleep
before and after the CBT and waiting list condition and between both conditions
after the training. Sleep complaints and quality consist of different
parameters: subjective sleep quality, sleep onset, sleep efficiency, amount of
sleep habits and sleep distortions. The are measured with a sleep diary and a
questionnaire.
Secondary outcome
Depressive symptoms are measured with the help of the Beck Depression
Inventory (21 items focussing on symptoms in the past week). The quality of
life questionnaire OQ-45 is used to measure quality of life and the DBAS 16
(dysfunctional beliefs about sleep) is used to measure negative thought about
sleep.
Background summary
Insomnia is a very common complaint within the psychiatric population and is
often seen comorbid to a depressive disorder. The last decennia non
psychopharmacological treatment has become focus of interest. Especially
treatment with cognitive behavioral therapy has produced promising results in
short and long term effects on treating insomnia. With the increase of
research focused on insomnia and depression, there is also an increase in the
versatility of hypotheses and research protocols. It is striking to see the
limited amount of research in the chronic psychiatric population (>2 years of
psychiatric care and treatment for depressive complaints and insomnia). This
study will focus on verifying if CBT, besides the offered care as usual, has an
effect on insomnia, depression and quality of life as results for now in non
chronic populations are showing.
Study objective
Will a sleep training consisting of CBT in a chronic, psychiatric population
with depressive disorder and insomnia lead to a decline of sleeping problems
and a increase in sleep quality? Will the results from a normal and non chronic
population will be replicable?
Hypotheses:
1. CBT for insomnia will lead to a significant decrease in sleep problems and
sleep quality compared to a control waiting list condition.
2. CBT for insomnia will lead to an increase in general quality of life
3. CBT for insomnia will lead to a decrease in depressive disorder compared to
the control waiting list condition.
Study design
In this experimental randomized intervention design participants will be
assigned to an experimental (CBT) or control (waiting list) condition.
Participants first have to fill out different questionnaires with a minimal
score of 18 on the BDI depression inventory and meet the criteria for insomnia.
During a second intake and 2 other moments during this study questionnaires
about sleep habits, thoughts about sleep, sleep quality and a sleep diary will
be handed out. The CBT condition consists of 8 weekly sessions and one follow
up session. Participants assigned to the waiting list condition will be offered
to attend CBT for insomnia afterwards.
Intervention
Participants will be assigned to either a treatment or control condition.
Treatment consists of 8 weekly 90 minutes sessions and one more follow up
session after 4 weeks. The treatment will be added to care as usual. The
trainer will be a psychologist or a GZ psychologist.
The treatment consists of 3 parts specifically aimed at insomnia: psycho
education, cognitive behavioral therapy and relaxation therapy.
Sleep hygiene will be the main part of psycho education. Participants will
receive information about the sleeping cycle, and the influence of behavior on
the sleep pattern.
The role of negative thoughts in maintaining sleeping problems will be the
focus of CBT. Most thoughts are present for years and are viewed as reality and
impossible to change. This conception will be challenged through different
methods.
The final part of the treatment will be relaxation therapy practicing exercises
like progressive relaxation and autogenic training.
The control condition will be a waiting list and participants in this group
will be offered the treatment after an 10 week waiting list.
Study burden and risks
Risks for participants are minor. Participants can quit at any time. Besides 2
indivuals appointments, they have to visit the hospital to attend the training
9 times in total. There are 3 measurement moments (2 after a session)for the
experimental condition and they have to fill out the sleep diary daily for 14
weeks. The waiting list condition has 2 (individual) measurement and have to
fill out the sleep diary for 10 weeks.
Goudesteinstraat 1
3223DA Hellevoetsluis
NL
Goudesteinstraat 1
3223DA Hellevoetsluis
NL
Listed location countries
Age
Inclusion criteria
1. Age between 18 and 65 years old.
2. Chronic patient, meaning more than 2 years in treatment
3. BDI depression score > 18
4. Meeting the criteria of insomnia according to DSM IV criteria
5. Fixed medication administration during participation
Exclusion criteria
1. Acute psychiatric illness interfering with participation of treatment, consuming information, accomplishing homework. I.e. manic episode or PTSD.
2. Participating in psychotherapy during research
3. Seasonal mood disorder
4. Intelligence < 75
5. Sleeping problems with a treatable organic cause
6. More than average alcohol usage. More than 2 units a day, independent from sex
7. Current drug abuse
8. Insufficient skill of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33196.097.10 |