The aims of this research are to estimate the efficacy of a relatively brief group CBT for bipolar disorders, by following the level of mood symptoms over time, and by assessing whether changes in dysfunctional attitudes and sense of mastery over…
ID
Source
Brief title
Condition
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Group CBT as an adjunctive intervention for bipolar disorder is effective in:
• Primary outcomes:
o Decrease in dysfunctional attitudes
o Increase in sense of mastery over life outcomes
Secondary outcome
• Secondary outcomes:
o Decrease in (subsyndromal) symptoms of bipolar disorders
• Tertiary outcomes:
o Decrease in comorbid physical en psychological symptoms
o Improvement of psychosocial functioning
o Increase in quality of life
Background summary
Aanpassing nav vraagbrief METC dd 9-4-2014:
British and Dutch guidelines for bipolar disorder (NICE, 2006; Nolen et al,
2008) emphasize the use of CBT as a psychological intervention (amongst others)
in the treatment of bipolar disorders, but as is described in national and
international guidelines relatively little research is conducted in this area
(APA, 2010; Hirschfield, 2005; NICE, 2006; Nolen et al, 2008). To our
knowledge, no Dutch CBT protocol for bipolar disorders is validated in
research, or even considered evidence-based practice. Moreover, CBT is mostly
administered as individual, not group treatment. Our objective in this research
is to conduct a preliminary study to generate hypotheses on the efficacy of a
cognitive behavioural group intervention for bipolar disorder, which can be
tested in further analytic studies.
Study objective
The aims of this research are to estimate the efficacy of a relatively brief
group CBT for bipolar disorders, by following the level of mood symptoms over
time, and by assessing whether changes in dysfunctional attitudes and sense of
mastery over life outcomes occur. A further aim of the current study is to
evaluate changes in comorbid physical and psychological symptomatology,
psychosocial functioning and quality of life.
Study design
In this study, a case series design will be used, with an A-B multiple baseline
design, involving a baseline, a treatment and a follow-up phase.
When being enrolled in this study, participants and therapists will complete a
number of questionnaires and interviews. From then on, participants will start
charting or monitor their mood. At the start of the intervention, participants
will complete a battery of questionnaires. In addition, they will continue to
monitor their mood during the intervention. Directly after the intervention
phase, participants will complete the same battery again. Therapists will
assess the severity of the overall illness, manic and depressive symptoms
weekly during the intervention phase. Participants will monitor their mood
until follow-up after the intervention is finished. At follow-up at 2 and 12
months, participants will complete the battery of questionnaires again.
In each of the participating locations, the CBT group will take place one or
two times annually. The period of data gathering will be from now on.
Intervention
We will use a Dutch group CBT protocol for bipolar disorders.
Study burden and risks
Aanpassing nav vraagbrief METC dd 18-6-2014:
The burden for participants in this research will mainly consist of repeatedly
completing questionnaires. In mental health, it has become common practice and
even obligatory to monitor effects of treatment (routine outcome monitoring) to
be able to evaluate the efficacy of individual treatment, psychological
treatments or teams, to conduct research and to answer for results to other
parties such as management, health insurance companies and government (Buwalda
et al, 2011; Van Hees et al, 2011). In this study, a substantial part of the
instruments is frequently used in treatment as usual in routine outcome
measurement and diagnostics, only some of the instruments are added for the
gathering of data fit this specific research.
We expect no risks for participants as a result of participating in this
research and the intervention.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Aanpassing nav vraagbrief METC dd 9-4-2014:
Inclusion criteria in this study are:
- >= 18 years of age,
- A primary diagnosis of DSM-IV bipolar I or II disorder,
- Euthymic state or only mildly depressed or hypomanic at the start of the intervention,
- >= 1 episode in the past 18 months,
- Lifetime <= 12 previous episodes (since CBT has proven to be less effective in those with more than 12 previous episodes (Scott et al, 2006).
- Receiving treatment as usual.
Exclusion criteria
Participants will be excluded from this study if the presence of comorbid conditions is obviously impeding their ability to participate in the intervention (for example: substance abuse, mental retardation, organic brain disorder, the presence of a concurrent significant medical condition, severe suicidality or psychosis). Furthermore, participants will be excluded if they are currently receiving other psychological treatments.
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 | NL47889.060.14 |