Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02281175 |
| Other study ID # |
CRIUGM-003 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2014 |
| Est. completion date |
July 2018 |
Study information
| Verified date |
March 2022 |
| Source |
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Benzodiazepines (BZD) are widely used to treat anxiety, insomnia, and depression. These drugs
can have very serious side effects if they are taken over a long period of time. In addition
to stability, memory, concentration, vigilance, and attention impairments, long-term use of
BZD is also associated with an increased in hypertension incidence, urinary incontinence,
coronary artery disease, and renal complications. There are growing evidences that long-term
BZD use causes physical and psychological dependence as evidenced by the withdrawal syndrome.
The recommended strategy by physicians to facilitate the withdrawal of BZD is to gradually
reduce the medication, either by replacing the BZD by another with a longer half-life, or by
the gradual dose reduction. Unfortunately, the success of such a procedure is low as up to
80% of people who try to quit, relapse due to the intolerance of withdrawal symptoms.
Therefore, it is important to find new strategies to overcome the withdrawal difficulties.
The aim of this study is to test the effectiveness of a novel psychosocial intervention
called PASSE-65+ to facilitate the benzodiazepine withdrawal in the older users, thus
providing a new therapeutic tool to physician.
Description:
Benzodiazepines (BZD) represent the most frequently consumed drugs by the elderly persons in
Canada. Indeed, there is 7.5 times more BZD users in older people (65 years and over) than in
adults (18-64 years). Importantly, more than 50% of seniors who received a prescription of
BZD do not display any severe psychiatric symptoms and are physically in good health.
Results from a survey including 2811 community-dwelling older adults (65 years and over)
showed that 32% of the respondents consumed BZD for an average of 205 days and 60% of them
had at least received one potentially inappropriate prescription during this period (e.g. a
prescription of a BZD with a long half-life or a prescription of 2 BZD for more than 6
consecutive weeks, etc.). Another study showed that 45% of new BZD users take these drugs for
more than 30 days. It should be noted that the definition of a long-term BZD use varies from
three to four months of consumption, which corresponds to the average period used by almost
all seniors.
Long-term use of BZD by older people is a complex phenomenon that can be explained by several
personal, psychological, and social factors interacting with each other. Systemic model of
BZD consumption in late-life implies the following five elements which contribute to initiate
and maintain BZD taking: 1) history (i.e. autonomy loss, stress, disease apparition, etc.);
2) the prescription process; 3) personal dispositions (i.e. sexe, age, education, loneliness,
etc.); 4) sociocultural factors (i.e. positive attitude of their family or their physician
toward BZD use); and 5) cognitive strategies (e.g. trivialization of concerns about the
drugs, etc.).
To the researcher's knowledge, very few randomized controlled clinical trials have tested the
effectiveness of non-pharmacological interventions in patients with a mean age of 60 years
and older. Data from these studies showed that brief intervention (e.g. receiving either an
informative leaflet on BZD withdrawal during a meeting with the doctor or an informative
letter by post mail) or psychological interventions (including cognitive behavioral therapy
or CBT) are most likely more effective than the standard care and in some cases, to the
gradual dose reduction (GDR) supervised by a physician. However, only 10% (brief
intervention) to 85% (cognitive behavioral therapy designed to treat insomnia) of
participants completely stopped BZD use at the end of treatment. Furthermore, Parr and
colleagues indicate that the complete stop of BZD consumption remains difficult and still a
big challenge to patients, clinicians and researchers.
Nevertheless, one of the limitations of these studies is the large variation of age of their
participants (ranging from 18 to 85 years, despite a mean age of over 60 years), thus
restricting the generalization of the findings to older patients. Moreover, these results
derive from efficacy studies (vs effectiveness studies) designed to improve internal validity
at the expense of external validity. Although these results demonstrate the potential
efficacy (vs effectiveness) of non-pharmacological treatments to facilitate BZD withdrawal,
very few elderly users receive such interventions due to lack of resources, expertise and
time or simply due to their expensive implementation cost. Finally, to the investigator's
knowledge, no psychosocial intervention based on cognitive-behavioral therapy (CBT) and
including other specific personal, psychological, and social components associated to aging,
and targeting older people with different psychological problems (i.e. not only insomnia but
also anxiety or depression) has been tested. Therefore, the researcher hypothesized that the
"Programme d'Aide au Succès du SEvrage (PASSE-65+)" could be more suitable and effective to
help older people in their BZD withdrawal management.
In order to answer the investigator's hypothesis, long-term older users of BZD will first
receive a clinical assessment to determine whether they meet the research criteria. The
participants (n=75) will then be randomly allocated to one of the following three groups: one
group will receive an informative document (describing the steps for a gradual self-weaning),
a second will receive the same informative document and will have a 30 minutes meeting with a
physician once a week, and the third group will receive the informative document, will meet a
physician once a week and will receive a psychosocial intervention (PASSE-65+).
It is noteworthy that the psychosocial intervention will also be offered to the first 2
groups at the end of the study.
The research study will be conducted during a 12 week-period for the first 2 groups. For the
third group, the intervention will be offered on 12 sessions during a 16 week-period.
All groups will undergo three additional assessments (2 to 14 days, 3 months and 12 months)
following end of interventions. These last assessments aim to measure the rate of relapse,
withdrawal symptoms, intensity of anxious and depressive symptoms, and the sleep quality of
participants.
Finally, 15 participants will be randomly chosen and divided into 3 groups (n=5): One group
will be constituted by BZD users who completely stopped taking their drug, the second one
with BZD users who diminished their consumption and the third one with participants who
relapsed or dropped out. All participants from these groups will be interviewed at home to
collect their opinion about the PASSE-65+ program.
