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- This Page is the webedition of the CapOpus protocol -
CapOpus - Cannabis and Psychosis
Randomized clinical trial: Specialized addiction treatment versus
treatment as usual for young patients with cannabis abuse and psychosis
Read more about CapOpus after the résumé:
RESUME
Background
One fourth of the
first-episode psychotic patients referred to the OPUS trial (a treatment for
young people with psychosis) in Copenhagen and Aarhus had a comorbid diagnosis of substance abuse, and the vast majority of
these had abuse of cannabis. The use of cannabis is associated with worsening
of prognosis regarding development of symptoms, compliance to treatment, and
number of days in hospital. Trials examining the effect of interventions
addressing the cannabis use of young people with psychosis are consequently
required
Method
Young
people with a psychosis in the schizophrenia-spectrum (F2 in ICD-10) and
co-occurring cannabis abuse (F12 in ICD-10) are included in the trial. The
study is a randomized single-blinded clinical trial of the effect of
specialized addiction treatment compared with treatment as usual. Treatment as
usual is not homogenous, but is either in OPUS, Community Mental Health Centre
or Assertive Community Treatment. The specialized treatment encompasses a month
of individual treatment with ‘Motivational Interviewing’, followed by three
months of group-based treatment, and finally two months of individual
treatment.
During
the entire 6-month specialized treatment, meetings are held with the patients’
family and the case manager. This is to ensure that these important supporting
networks in the life of the patient are informed and knowledgeable about the
factors that contribute to decreased cannabis use. Harm-reduction is the
primary goal for the intervention.
Two
therapists lead the group intervention together and carry out the specialized
treatment. They maintain contact with the patient’s case manager, and offer
additional contacts with the patient and family.
A
research assistant, who is blinded to which kind of treatment the patient has
been randomized to, performs the examinations of the patient. This is done at
baseline, after six months, and again after ten months. The primary outcome
measure is days of abuse during the last month before follow-up, measured with
time-line follow-back and validated with measures of THC in blood samples. The
plan is to include 120 patients in the trial. The study has sufficient power to
detect a reduction from 20 days to 15 days with cannabis abuse during the last
month before follow-up at the five percent statistical significance level.
Statistics
Dropout
analysis will be carried out, as well as ANOVA with repeated measurement
analysis with interaction analysis of time and type of treatment. This is to
evaluate the effect and reduce the bias due to skewed attrition.
Organization
Staff at
Copenhagen University Hospital, Psychiatric Centre Bispebjerg, will
carry out the trial. The patients can be referred to the trial by psychiatric
outpatient clinics in the whole region of Copenhagen.
Read more about it:
Head of
trial: Merete Nordentoft, M.D, Professor, Ph.D. MPH.
Project
Leader Allan
Fohlmann, clinical psychologist. Conducting the intervention.
Project
Leader Anne-Mette
Larsen,
occupational therapist. Conducting the intervention.
Research
Assistant Carsten Hjorthøj, MSc. in Public Health Science. Conducting the
research.
Head of
department, MD, dr. med. Sci., Copenhagen Trial Unit, Rigshospitalet.
All
project staff are employed in:
CapOpus
Copenhagen University Hospital
Psychiatric Centre Bispebjerg
Bispebjerg Bakke 23,
2400
Copenhagen NV,
Denmark
Tel: +45 35 31
62 42
The
randomized clinical trial aims to examine the effect of specialized treatment
of cannabis abuse amongst young people with psychosis. Specialized addiction
treatment is compared with treatment as usual. Treatment as usual is a
non-specialized, non-manualized treatment.
In order to
examine the effect of the two treatments, patients are randomized to either
specialized addiction treatment or treatment as usual.
A recent
meta-analysis of longitudinal studies concluded that cannabis use is associated
with increased risk of long lasting psychotic conditions later in life [Moore
et al., 2007;Nordentoft and Hjorthøj, 2007].
Abuse of cannabis among patients
with psychosis can maintain and worsen the psychotic symptoms [Linszen
et al., 1994;Grech et al., 2005;Hides et al., 2006;van Os et al., 2002]. Several studies show that use of cannabis increases the risk of
development of schizophrenia-like symptoms, especially in young men disposed to
developing psychosis [Zammit
et al., 2002;Arseneault et al., 2002;Arseneault et al., 2004;Henquet et al.,
2005;Smit et al., 2004;Stefanis et al., 2004;Hall, 2006]).
Comorbid schizophrenia and substance
abuse (dual-diagnosis) have been associated in several reviews with lack of
compliance to treatment. A systematic examination of hospitalized patients with
schizophrenia found that lack of compliance to the treatment was related to
substance abuse and lack of insight [Kamali et al., 2001]. A follow-up study of patients with
schizophrenia and cannabis abuse found significantly more rehospitalizations,
worse psychosocial functioning, higher levels of thought disorders and more
pronounced paranoia compared to non-abusing patients with schizophrenia [Caspari, 1999]. In the
”Reference Programme for Schizophrenia” [Sekretariatet for referenceprogrammer, 2004], the Danish National Board of
Health makes the following recommendation:
"Since patients with
schizophrenia and concomitant cannabis abuse have a poorer prognosis, the
treatment system should therefore develop treatment methods that are effective
at alleviating cannabis abuse."
A Cochrane review from 2006
concludes that both Cognitive-Behavioural Therapy (CBT) and Motivational
Enhancement Therapy / Motivational Interviewing have been demonstrated to be
effective to reduce cannabis use, both when given individually or in group
sessions. Two studies on contingency-management treatment conclude that this
may enhance outcomes combined with CBT or motivational enhancement[Denis et al., 2006].
The literature suggests that
cannabis abuse can be treated using methods that are effective for other types
of abuse. Several randomized trials show an effect of cognitive behavioural
therapy in dual diagnosis patients[Waldron and Kaminer, 2004];
however,treatment programmes that combine motivational interviewing, family
involvement, and cognitive behavioural treatment seem to be more effective[McRae et al., 2003;Carroll, 2005].
A Cochrane review from 2002
concludes that insufficient evidence exists to show that any intensive
treatment method is superior to others[Jeffery et al., 2000]. It is recommended not to offer the
treatment separately but as a part of treatment programmes[Drake
et al., 2004;Linszen et al., 1994].
A randomized trial showed that
the combination of cognitive behavioural therapy, motivational interviewing,
and family involvement had a significant positive effect on level of
functioning, psychotic symptoms, and duration of periods without abuse,
compared with regular treatment[Barrowclough et al., 2001]. Two reviews conclude that there is
positive evidence for integrated treatment with motivational interviews,
cognitive behavioural therapy (individual or group-based), 12-step treatment,
and a harm-reduction approach[RachBeisel et al., 1999;Ziedonis, 2004].
There is no
clear evidence to show that group-based interventions are superior to
individual treatment[Greene, 2002;McRobert et al., 1998]. Treatment in groups is less
expensive. In a literature review, Weiss et al. conclude that specialized group
therapy can reinforce the effect of the existing treatment[1992].
A randomized controlled trial on group therapy for dual diagnosis
patients concludes that it is possible to reduce substance use in individuals
with psychotic disorders, using a targeted group-based approach[James
et al., 2004]. Similar results were found in an
earlier study from 1999 which showed a significant positive effect on symptoms,
level of functioning, and lower costs for supportive services by robustly
implementing a manualized behavioural group intervention[Jerrell and Ridgely, 1999].
There is
evidence for the efficacy of a stepwise or phase-specific treatment that is
successively based on engagement, motivation, coping with symptoms, and
preventing relapse[Drake et al., 2004].
A review of
the literature shows that there is a lack of randomized trials that can ensure
that the treatment of patients with dual diagnosis is evidence-based. This
trial will assist in solving this problem by building on best practice.
Therefore, we plan a trial in which individual and group-based, combined
treatment, such as motivational interviewing, psychoeducation, cognitive
behavioural therapy, and social skills training is compared with treatment as
usual.
The patient
is connected to a case manager who is offered education and supervision by one
of the two addiction consultants employed in the trial-project.
The
addiction consultants are both directly and indirectly involved in the
treatment of the patient. During the month prior to the group intervention, one
of the addiction consultants is in contact with the patients once or twice a
week. A meeting is also held with the patient’s family and fortnightly contact with the case manager is established.
During the
three months of group intervention, one of the addiction consultants has weekly
individual contacts with the patient and two meetings with the family. In
addition, the patient follows the weekly group intervention (12 meetings of 1½
hours) and has fortnightly consultative contacts to the case manager.
During the
two months following the group intervention, the addiction consultants are in
weekly contact with the patient and the family is invited to a meeting. The
addiction consultants contact the patient’s case manager every three weeks.
For the
purpose of creating alliance and motivation, the treatment starts with
motivational interviewing [Miller, 1983;Miller and Rollnick, 1991]. There is good evidence for the
efficacy of motivational interviews in short-term treatment [Hettema
et al., 2005; Burke et al., 2003].
The patient
formulates individual goals for the treatment and is offered the group
intervention. The groups consist of 6 to 8 patients, with the addiction
consultants as trainers. Each group runs for three months with weekly sessions
lasting 1½ hours. The group is conducted at a fixed time and weekday and the
structure of the agenda is the same at all meetings.
The group
intervention is followed by two months during which the individual weekly
meetings with the patient continue. The two addiction consultants offer
consultative assistance to the patient’s case manager, who also has the
possibility of involving the consultants directly in the treatment of the patient.
The entire specialized treatment programme, in which the addiction consultants
are involved, amounts to six months.
A
manualized treatment programme based on the Australian EPPIC manual [Hinton et al., 2002] especially developed for
first-episode psychotic patients with cannabis abuse is used. This method is
well described and incorporates methods with a high degree of evidence.
Motivational interviewing with analyses of advantages and drawbacks of
continued abuse are used. Instruction is given in coping skills in relation to
craving and situations that usually trigger abuse, and in developing personal
strategies for avoiding or handling these situations. Furthermore, strategies
for handling withdrawal symptoms and for preventing relapse are facilitated.
General
coping skills are introduced, such as handling unpleasant emotions,
stress-management, social skills training, and relaxation techniques.
An element of contingency management
is introduced to enhance motivation for participation in the group intervention.
In a Cochrane Review from 2006, Denis et al. conclude that contingency
management treatment may enhance outcomes combined with CBT or motivational
enhancement [Denis et al., 2006] Contingency management in the
CapOpus trial is solely connected to positive reinforcement of attendance in
the group intervention. It has no connection to whether or not the use of
cannabis is decreased. Patients are offered participation in free excursions,
cinema visits etc. in the company of one of the addiction consultants. Also,
sandwiches are served in conjunction with group sessions.
An
important part of "Cannabis and Psychosis" is to understand and to help
the patients understand the mechanisms that prevent them from abstaining from
cannabis. The overall target is harm reduction, a method which has proved
effective in several studies [Ziedonis, 2004b; Rachbeisel et al., 1999]. The treatment is based on the patients’ own
goals for tackling cannabis abuse.
The
treatment is structured around the circle of change [Prochaska, 1991; Prochaska and Diclemente,
1992]. This describes changes in
behaviour as a process that runs through phases of pre-contemplation, contemplation,
preparation, action, and maintenance. Relapse is considered to be an integrated
part of the process, after which the phases must be repeated.
Pedagogy of
the group intervention takes into account that psychotic patients most often
have subnormal cognitive functioning. It is therefore important that the
structure of each session is predictable and over-learning is encompassed. This
is done by using the same agenda at each session:
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Round – what has happened the
past week.
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Repetition from last session.
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Homework assignment for this
session.
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Talk/psychoeducation (new topic
in each session).
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Discussion of participants'
experience with the topic.
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New homework assignment.
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Finishing round – evaluation.
The active
participation of the patients is facilitated through discussions and
role-playing and homework between each session. To increase motivation, the
teaching is made relevant in relation to the life of each patient and their
individual goals for the treatment. The overall principles are described in the
manual, but each session leaves room for adaptation to the patients’ wishes and
stage in the circle of change.
Therapist
roles are directive
and direct, but non-confronting non-critical. Emphasis is on empathy and
positive reinforcement, problem solving and generalization to the patients’
daily life. The atmosphere is sought to be relaxed and with room for humour.
For the concluding part of the group intervention, a patient with former
cannabis abuse is involved as a role model.
Methods
of treatment are
all part of the cognitive therapeutical framework, using psychoeducation,
cognitive behavioural therapy, and social skills training. The aim is to ensure
that the patients gain insight into inappropriate patterns of thoughts and
actions and develop coping strategies. This is facilitated through: Exploration
of the patient’s reasons for using cannabis and the connection to
symptomatology. Mapping of advantages/disadvantages of cannabis use and
cessation of use. Warning signs of craving/relapse. Problem-solving skills and
coping skills for symptoms. Use of behavioural chain analysis (Mørch and
Rosenberg, 2005). Work with negative automatic thoughts and alternative
thoughts. Social skills training (e.g. to refuse drugs, solve conflicts, and
engage in new contacts). Facilitating daily and recreational activities.
Relapse prevention and developing a crisis plan.
Structure
of the modules in the group-intervention:
The structure of the intervention is based on
the stages in Prochaska and Diclemente's model of change (circle of change). The model is
based on the view that the patient often fluctuates between the different
stages and undergoes relapses before being able to reach the final stage, which
marks lasting change.
In order to
support the group and patient in the process of changing lifestyle, the
therapists must be able to identify the current stage of the group/patient.
Thus, the intervention can be aimed specifically, either by being oriented
towards motivation enhancing or advisory techniques, or by changing focus, e.g.
from exploring reasons for change to making plans for change. The purpose is to
motivate the patient to move on through the stages; therefore, the model is
also called “the motivational cycle” or “circle of change”. In this way, each session
in the group can be adapted to the participants’ motivational level and stage
of change.
Sessions
for the pre-contemplation stage:
Psychoeducation about:
Knowledge of psychotic symptoms.
Knowledge of the psychosis-inducing effect of
cannabis.
Knowledge of risks and harms caused by cannabis
use.
Knowledge of abstinence symptoms following
cannabis use [Denis et al., 2006]
Knowledge of the effect of decreased use (harm
reduction).
Mapping the individual pattern of use, with
focus on disadvantages of cannabis use and the triggers for craving and use.
This is done by using registration charts.
Contemplation
stage:
Exploration of pros and cons of cannabis use and cessation of use.
This is used with the aim of replacing some of the advantages of cannabis use
with other interventions.
Exploration of connections between cannabis abuse and symptomology.
Ambivalence and resistance is addressed from an accepting viewpoint.
Exploration of pros and cons
Smoking Cannabis Cessation of use
Advantages:
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Advantages:
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Disadvantages:
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Disadvantages:
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Adapted from Beck, A.T., Wright, F.D., Newman, C.F.
& Liese, B.S. (1993) Cognitive therapy of substance abuse. New York: The Guilford Press; Mørch, M.M. &
Rosenberg, N.K. (red.): Hans Reitzels Forlag 2005.
Preparation
stage:
Individual
goal-setting with focus on disadvantages of cannabis use. Exploration of the
connection between cannabis use and symptomatology. Development of
symptom-coping skills and alternative coping strategies. This is facilitated
through exploration of pros/cons, behavioural chain analysis and exploration of
negative automatic thoughts and actions in relation to the cannabis abuse.
Social
skills training to enhance ability to refuse drugs, solve conflicts, and
initiate contacts to non-users. Introduction to the problem-solving model
[Denis et al., 2006]Mørch and Rosenberg, 2005). (SAMHSA: http://mentalhealth.samhsa.gov/cmhs/communitysupport/toolkits/family/workbook/problem.asp)
Steps of the Problem-Solving Process:
Step 1. Define the problem or goal.
Step 2. List all possible solutions.
Step 3. Discuss first advantages and then disadvantages of each in turn.
Step 4. Choose the solution that best fits the situation.
Step 5. Plan how to carry out this solution by forming a detailed action plan.
Step 6. Carry out the plan
Step 7. Review implementation.
Action stage:
Problem
solving, where coping strategies are tested. Mapping of warning signs for
relapse and triggers for cannabis use. Individual crisis plans in relation to
relapse and worsening of symptoms.
Maintenance
stage:
Development
of new skills and habits in daily life. Support (in cooperation with the case
manager) to maintain an active life with focus on activities of daily life
(ADL), exercise and work/education/recreational activities. Widening of
personal network with non-cannabis users. Training of general coping skills
such as social skills training, handling of unpleasant emotions, stress
management, and relaxation techniques. Strategies for relapse prevention and
coping strategies for craving are tested in daily life. Involvement of patient
with former cannabis abuse as a consultant and role model.
Relapse:
De-dramatizing
and normalization with focus on learning from relapse. Support in order to
re-engage in the stages of change, with focus on the patient's own coping
strategies.
Programme fidelity
To ensure
programme fidelity in the intervention, the number of contacts with the
patient, the patient’s family, and the case manager are registered during the
six-month intervention period. Forms for registration of programme fidelity are
implemented in individual and group senssions. Registration forms are also used
to ensure that the planned content in the group intervention is sufficiently
implemented. These forms are anonymized and reviewed by the research assistant.
To ensure
method fidelity the addiction consultants are supervised by an external
supervisor with expertise cannabis abuse, motivational interviewing, and
cognitive behavioural therapy.
The
non-specialized treatment programme is carried out by staff in OPUS (a
treatment for young people with psychosis in Copenhagen), in Assertive Community Treatment
or in Community Mental Health Centres. Thus, the control intervention is
identical to the treatment that is ordinarily offered to this patient-group.
The frequency of contact with the patients may vary. There is no standardized
manual for this treatment. The treatment approach is supportive and not
condemnatory. It is important to advise the patient about alternative coping
strategies and to encourage every small reduction in abuse.
A research
assistant is responsible for conducting interviews at the time of inclusion in
the trial, at six months, and again ten months later. Thereby, the first
follow-up interview is held when the specialized CapOpus treatment is
concluding. The second follow-up interview is held four months after the
specialized treatment has ended.
The
assessment instruments used as effect measures are all validated psychometric
scales, which the research assistant is certified to use.
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The patient must fulfil
research criteria for F2 in ICD-10 (schizophrenia and schizophrenia-like
conditions) and diagnosis of F12 (Mental illness or disturbances caused by
cannabis). Cannabis abuse must be the dominant form of abuse. Other
substance abuse may be present sporadically.
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The patient must understand
Danish to the extent that assessment and treatment can be conducted
without an interpreter.
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The patient must give informed
consent to participate in the trial. In addition, the patient must consent
to participate in the CapOpus project and to continuation or initiation of
treatment for the psychiatric condition.
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Patients in OPUS, Assertive
Community Treatment, Community Mental Health Centres, psychiatric wards,
and others who meet the criteria can be included in the trial.
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Patients must be 18-35 years of age and have legal residence in the municipality of Copenhagen or Frederiksberg
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Patients who meet the criteria
of alcohol-dependence syndrome (F10.2), opioid dependence syndrome (F11.2)
or cocaine dependence syndrome (F14.2)
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Patients who do not give
informed consent
Referred
patients will be assessed by a research assistant to ensure that they meet the
criteria for inclusion.
Included
patients are randomized to either specialized addiction treatment (CapOpus) or
to treatment as usual. The Copenhagen Trial Unit (CTU) conducts the
randomization. A research secretary is responsible for contacting CTU and for
informing the patient about which kind of treatment he or she has been
randomized to receive. Only CTU will know the block size of the randomization.
The randomization is stratified for severity of cannabis addiction, measured by
using Time Line Follow-Back (up to 14 days in the last month versus 15 days or
more); and for the type of treatment setting (OPUS, Assertive Community
Treatment, or Community Mental Health Centre), in order to ensure that patients
from each type of setting are evenly distributed between the intervention group
and control group. A secretary in the trial is appointed a PIN code to CTU and
makes a telephone call to inform of the patients social security number and
serial number. CTU sends an e-mail with information of which treatment the
patient is allocated to. The identification of the patient is secured by the
serial number.
The design
of the trial implies that the same case manager can treat patients in the
intervention group as well as in the control group. This is a drawback of the
trial and can mean that the treatment methods used in the specialized CapOpus
treatment are also used in the control group.
Therefore,
the follow-up analysis of patients in the control group must examine whether
any differences occur between those who had a case manager with a patient
receiving specialized treatment and those whose case manager did not have
patients receiving specialized treatment.
The trial
is not blinded for therapists or patients, but the research assistant is
blinded to treatment allocation. The patients are instructed not to tell the
researcher which treatment they were allocated to. To register whether the
blinding is effective, the research assistant registers his guess of the
patient's treatment allocation.
The
following effect measurements are used at baseline, after six months and after
ten months:
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Severity of abuse. Assessment
of number of days with cannabis abuse during the last month with Time Line
Follow-Back [Sobell and Sobell,
1992;Donohue et al., 2007]. This effect measurement is
the best for measuring the effect the trial aims to influence; namely
whether number of days with cannabis use can be reduced. Information
supplied by patients on cannabis use will be validated with the results of
blood analysis. Blood tests are taken at the six-month and ten-month
follow-up interviews.
If comparison of results of blood
analysis and the patient’s self-report in Time Line Follow-Back indicates that
the patient's reports are reliable, Time Line Follow-Back is used to measure
effect.
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Influence and severity of other
substance use, including prescribed medication, and establishment of the
severity of consequences of cannabis use, are assessed using sections 11 (use
of alcohol) and 12 (use of psychoactive substances other than alcohol) of the SCAN
interview (Schedules for Clinical Assessment in Neuropsychiatry).[Wing et al., 1990]
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Psychosis symptoms are assessed
by the use of The positive and negative syndrome scale (PANSS) for
schizophrenia. [Kay
et al., 1987] A
psychiatrist, who is blinded to patients' allocations, rates samples of
videotaped interviews to measure the reliability of the rating of these
interviews
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Cognitive function. Danish
Adult Reading Test (DART) is used as an estimate of prepsychotic IQ [Nelson
and O'Connell, 1978]. Speed of information processing is assessed
with BACS’ symbol coding and with Trailmaking A [Bowie
and Harvey, 2006;Keefe et al., 2004;Spreen and Strauss, 1998]. Attention/vigilance is assessed by Continuous Performance Test,
Identical Pairs Version [CPT-IP;
Cornblatt et al., 1989].
Working memory is assessed with Trailmaking B. Memory and verbal learning is
assessed with Hopkins Verbal Learning Test [Brandt,
1991]. Executive functioning
is assessed with NAB Mazes [Stern
and White, 2003].
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Social functioning (major life areas;
community, social, and civic life) is assessed with WHODASII [WHO, 2000].
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Quality of life is assessed
with Manchester Short Assessment of Quality of Life [MANSA;
Priebe et al., 1999] and
EQ-5D [Brooks,
1996].
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User satisfaction is assessed
with Client Satisfaction Questionnaire [Larsen
et al., 1979]
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Expenses for the experimental
intervention (CapOpus) and control intervention is measured by examining number
of outpatient treatment and bed days in both treatment groups.
Follow-up
is planned to be undertaken at six months, because patients in specialized
CapOpus treatment have just finished the intervention at that time. Follow-up
at ten months is chosen, because this allows for a four-month follow-up period
after the end of specialized treatment.
In order to
be able to detect a difference between the two types of treatment with regard
to the reduction of cannabis abuse, it is necessary to examine approximately 40
patients in each type of treatment. This is necessary in order to obtain a five
percent statistical significance level in the detection of a difference in
reduction of cannabis use from 20 days monthly to 15 days monthly (standard
deviation is estimated to be 5). In the group intervention, the maximum
inclusion is 24 patients annually (4x6); a therefore, it is necessary for the
project to continue for several years in order to recruit the necessary number
of patients. A loss to follow-up is anticipated from both research interviews
and from intervention. Therefore, it is planned to include 70 patients in each
type of treatment.
The
necessary number of patients can be ensured by launching the project as a
cooperation between the three OPUS teams in Copenhagen, Assertive Community Treatment,
Community Mental Health Centres, and treatment facilities for cannabis abusers
in Copenhagen and Frederiksberg.
Continuous
outcome measures will be analysed with ANOVA analyses of variance. Dropout
analysis will be carried out comparing the group of patients who complete the
entire experimental treatment with the population who enrolled in the trial.
Baseline
values of measures are included as covariates in the analysis whenever
possible. To counteract the effect of skewed attrition, repeated measurement
(mixed model, unstructured variance) analysis with interaction analysis of time
and type of treatment is used, in order to evaluate the effect over time.
Sensitivity analysis will be carried out, three hypotheses will be tested: that
all the dropouts have the same values as in the last measurement (last
observation carried forward), that all the dropouts have ceased cannabis use
completely, and that all dropouts have become daily users of cannabis.
The results of the trial will be published in national and international
journals. Authorship is determined in an agreement of cooperation for the
entire project. The publications will be publicized according to Consort and Vancouver
guidelines of publication of randomized trials.
The
participants are invited by letter to an assessment by the research assistant,
who presents the trial to the patients, both orally and in writing. The
research interviews can take place at Bispebjerg Hospital, in OPUS, in the patient’s home, or
wherever it may be possible. In the oral presentation, it is stated explicitly
that participation is voluntary and not dangerous, and that the patient can
withdraw informed consent at any time without any consequences for the
treatment. Oral and written informed consent are obtained. The trial is
registered with the ethics committee, the data surveillance agency and
'clinicaltrials.gov'.
The group intervention can beconducted on the premises at OPUS (Bispebjerg Hospital, Nannasgade), where the addiction
consultants can also be based. Inclusion of patients happens continuously. The
group intervention is planned with sizes of 6-8 patients, and each group has
ten sessions during the three months. It is possible to treat 9 groups during
the course of the trial. The individual treatment can be conducted at the
patients homes, if they wish so.
The project is conducted in
cooperation between the three OPUS teams. They are located in psychiatric
departments at three hospitals in Copenhagen: Bispebjerg Hospital, Hvidovre Hospital and Rigshospitalet.
The addiction consultants are
responsible for the group intervention and conduct training and supervision of
the case managers connected to the patients in specialized treatment. They are
also available for consultation or direct involvement in the patient’s
treatment, in cooperation with the patient’s case manager.
Consent has been given to
participate in a network of professionals within the field of substance abuse
in Denmark. This network will act as a follow-group for
the intervention. They will also be invited to seminars with dissemination of
the results and empirical findings obtained during the trial, as will the
network for professionals working with young people with mental illness.
The trial
is expected to increase knowledge of dual-diagnosis treatment, as well to
provide experiences with treatment according to the Australian manual, which
has not previously been used in Denmark
After ten
months, a seminar on dual-diagnosis treatment will be held to present the preliminary
results and empirical findings. The network of professionals as well as the
user-organizations of psychiatric services will be invited to the seminar. An
evaluation of preliminary results and empirical findings will be carried out,
and the treatment manual adapted accordingly. The preliminary results will be
published in journals.
A two-day
training seminar will be held for case managers of the patients involved in the
intervention in order to disseminate the methods of the project through
lectures, training and supervision.
Towards the
end of the trial, a conference will be held for relevant staff in
dual-diagnosis treatment on treatment methods and empirical findings of the
CapOpus trial. Proposals for continuation of the project will be prepared and
articles published in journals and news media.
A
concluding seminar will be held for collaborators and the network of
professionals, and a final evaluation and report of the trial will be
published.
March 2007:
Appointment of research assistant andaddiction consultants. Preparation of manualized description of the specialized
individual addiction treatment and the group intervention in CapOpus.
August 2007:
Inclusion of the fist patients.
September 2007:
Initiation of first groupintervention.
September 2008:
Seminar for network ofprofessionals and user organizations.
September 2009:
Training seminar for casemanagers.
November 2009:
Conference for relevant staffin dual-diagnosis treatment.
February 2010:
Concluding seminar. Finalevaluation and report on the project.
September 2010:
Reportof effect of the trial in scientific journals
A grant from The Health Insurance
Foundation (Sygekassernes Helsefond) has been obtained to cover the salary for
an addiction consultant (Allan Fohlmann). Grants from the Copenhagen
Council and The Lundbeck Foundation have been obtained to cover salary for a
year for an addiction consultant (Anne-Mette Larsen) and for a research assistant (Carsten Hjorthøj).
Funding for the additional two years
of the trial will be sought from The Egmont Foundation, The Health Insurance
Foundation, the Velux Foundation and The Danish Medical Research Council (DMRC)
-
Arseneault L, Cannon M, Poulton R, Murray R,
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Download here:
Who are we?
There are four of us.
Two responsible for the research and two responsible for the specialized treatment programme (CapOpus-treatment), i.e. conducting the
intervention
Responsible for the research:
Carsten Hjorthøj
Research
Assistant
MSc. in Public Health Science
Mobil: +45 2613 6290
Office: + 45 3531 6240
Merete Nordentoft Head of trial
Conducting the
intervention:
Allan Fohlmann
Project Leader
Mobil:
+45 2880 0169
 .
Mette Madsen
Occupational therapist
Mobil +45 2686 8466
Anne Mette Larsen.
Occupational therapist
Mobil +45 2880 0181
How to contact CapOpus
You are welcome to use the contact information in the list above or send a email to:
Postal adress:
CapOpus
Bispebjerg Bakke 23,
2400Copenhagen NV,
Denmark
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