Journal of Psychiatric and Mental Health Nursing, 2012, 19, 446–454

Nurse-led delivery of specialist supportive care for

bipolar disorder: a randomized controlled trial
M . C R O W E 1,7 r n p h d , M . I N D E R 2 d i p s o c w k p h d , D . C A R LY L E 3 r n p h d ,
L . W I L S O N 4,8 r n m h s c , L . W H I T E H E A D 9 r n p h d , A . PA N C K H U R S T 10 m s c ,
T. O ’ B R I E N 11 rn mphil (hons), C. FRAMPTON5 bsc phd &
P. J O Y C E 6 m b chb phd md (otago) franzcp
1
Associate Professor, 2Research Fellow, 3Senior Lecturer, 4Research Fellow, 5Associate Professor, 6Professor,
Department of Psychological Medicine, 7Associate Professor, 8Research Fellow, 9Senior Lecturer, 10Research
Assistant, Centre for Postgraduate Nursing, University of Otago, Christchurch, and 11Senior Lecturer,
School of Nursing, University of Auckland, Auckland, New Zealand

Keywords: evidence-based practice, Accessible summary

nursing, psychotherapy, quantitative
methodology • Bipolar disorder is a severe and recurrent mental disorder that has a long-term
impact on the patient’s ability to function.
Correspondence:
M. Crowe
• Specialist supportive care is a manualized psychotherapy that provides support and
psycho-education for self-management.
Centre for Postgraduate Nursing
University of Otago • This study provided specialist supportive care as an addition to usual care from
PO Box 4345 community mental health services.
Christchurch 8001 • It is not feasible to provide specialist supportive care to patients with bipolar
New Zealand disorder while they are in mood episode and receiving usual care.
E-mail: marie.crowe@otago.ac.nz
Abstract
Accepted for publication: 22 August
2011 The aim of the study is (1) to assess the feasibility of delivering nurse-led specialist
doi: 10.1111/j.1365-2850.2011.01822.x supportive care as an adjunct to usual care in the clinical setting; (2) to examine the
relationship between the delivery of specialist supportive care and improved self-
efficacy and functioning and reduced depressive symptoms. A randomized controlled
trial of the clinical effectiveness of specialist supportive care as an adjunct to usual care
was conducted in community mental health services at one site. Participants were
randomized to either usual care or usual care and the adjunctive intervention. Self-
report measures of depression, general functioning and self-efficacy were completed by
participants in both groups at baseline and 9 months. The intervention was delivered
parallel to usual treatment arrangements. While recruitment numbers were sufficient,
a low rate of engagement meant we were unable to show significant differences in
depressive symptoms or self-efficacy between the usual care group and the specialist
supportive care plus usual care group. This study demonstrated that it was difficult to
engage patients with bipolar disorder in specialist supportive care when they were
currently in a mood episode and under the care of community mental health services.

Disclosures: This project was funded by the Tertiary Education Com-
mission’s Strategy for Advancing Research project (STAR).
Conflicts of interest: The authors have no conflicts of interest to
declare.
Introduction
Bipolar disorder is a serious chronic mental disorder char-
acterized by recurrent episodes of depression, mania and
mixed mood. Although with medications the vast majority
of patients recover symptomatically from episodes of

446 © 2011 Blackwell Publishing


mania, and most recover from episodes of depression, in
recent years it has become apparent that functional recov-
ery does not inevitably follow symptomatic recovery (Keck
et al. 1998, Judd et al. 2003). Perlis et al. (2006) have
identified that even patients receiving optimal medication
are likely to have recurrences, have trouble holding jobs,
maintaining relationships and getting along with significant
others. As hospitalizations have become shorter, and as
patients are discharged in relatively unstable states, the
burden on family and community mental health services
is considerable (Perlick et al. 2007). Despite significant
strides in the pharmacological treatment of bipolar disor-
der, most patients cannot be maintained on drug treatments
alone (Miklowitz 2008). In response to this there has been
increasing interest in exploring the efficacy of psychosocial
interventions as adjuncts to medications (Crowe et al.
2010). Most of these studies have been conducted and
found to be efficacious under carefully controlled research
conditions. To date there have been very few studies con-
ducted in real-life clinical conditions. While efficacy studies
seek to limit variables that can influence outcome, effec-
tiveness studies approximate real-world conditions by
allowing multiple variables (Nasrallah et al. 2005).
This is an important distinction because most efficacy
studies exclude patients with particular characteristics,
notably co-morbid personality disorder or substance
misuse. As Scott & Colom (2008) have noted that patients
without a history of an additional axis I or axis II disorders
are the exception rather than the rule. Additionally, most
published studies of adjunctive psychotherapy for bipolar
disorder have recruited patients who were in remission
or euthymic on entry to the study (e.g. Colom et al. 2003,
Lam et al. 2003, Lam et al. 2005). Scott & Colom (2008)
have identified that further research is required into when
therapy should be commenced. There are few studies that
attempt to measure the effectiveness of an adjunctive psy-
chological intervention with samples that are representa-
tive of those with bipolar disorder most commonly seen in
clinical situations. Consequently, there is a current gap
between research efficacy and clinical effectiveness that
leaves clinicians with uncertainties about how therapies
will perform in day-to-day practice (Scott & Colom 2008).
An analysis of the overlapping versus modality-specific
ingredients of psychosocial treatments for bipolar disorder
found that the core components of modern psychosocial
approaches to bipolar disorder attempt to enhance the goals
of pharmacotherapy by teaching coping skills for managing
psychosocial stressors, recurrences, and the social stigma of
the disorder (Miklowitz et al. 2008). Miklowitz & Scott
(2009) have identified that a disorder-specific intervention
for bipolar disorder needs to incorporate the following
characteristics: an individualized formulation of the prob-
© 2011 Blackwell Publishing
SSC for bipolar disorder
lems experienced with bipolar disorder; the model of
therapy is shared openly with the patient; there is a clear
rationale for the techniques used; there is an emphasis on
psycho-education and skill development. Change is attrib-
uted to the patient’s, not just the therapist’s efforts and the
patient is encouraged to use illness management techniques
post-therapy.
Given the disabling and chronic nature of bipolar dis-
order, the limited efficacy of medication alone, and the high
rates of mental health service utilization, this study was
designed to examine the feasibility of a nurse-led psycho-
social intervention for clinically complex patients typical of
those treated in community mental health services. Special-
ist supportive care (SSC) was chosen because it meets each
of the criteria of a disorder-specific intervention outlined
above, is manualized and can be delivered by nurses expe-
rienced in caring for patients with bipolar disorder after a
short period of training and delivery. Specialist supportive
care is a psychotherapy for bipolar disorder based on sup-
portive psychotherapy and the American Psychiatric Asso-
ciation guidelines (American Psychiatric Association 1994)
for the management of bipolar disorder. It is a structured
individual psycho-education intervention that focuses on
identifying and managing triggers for mood instability and
developing strategies for managing this. The approach is
based on a stress-vulnerability model that allows patients
with bipolar disorder to develop a personalized under-
standing of the triggers to relapse and their response to
these triggers. The intervention incorporates the character-
istics identified by Scott (1996) as the promotion of inde-
pendent use of the skills learned and enhancement of the
individual’s sense of self-efficacy. The collaborative devel-
opment of a clinical formulation that emphasizes the indi-
vidual’s triggers, early warning signs and resources is
central to the intervention.
The purpose of the study was twofold:
• to identify the feasibility of a nurse-led intervention
for bipolar disorder with clinically complex patients
typical of those treated in community mental health
services, specifically recruitment, engagement and
retention in therapy;
• to identify if the addition of the psychotherapy, SSC,
to usual care (UC) would be effective in improving
patients’ self-efficacy and reducing depressive symp-
toms for patients with bipolar disorder.
Methods
Participants and setting
Participants were recruited from community mental health
services provided by a specialist mental health service in
447
M. Crowe et al.
one New Zealand District Health Board between June
2008 and April 2009. The Nurse Consultant (not a
member of the investigation team) for the service sent an
information pack containing an invitation letter, a study
information sheet, a consent form, the questionnaire which
included contact details and a stamp-addressed return
envelope to all patients in the service who met the inclusion
criteria identified via the electronic database. Participants
were included in the study if they were 18 years of age or
above, able and willing to sign an informed consent form
and had a diagnosis of bipolar disorder. The only exclusion
criterion was severe alcohol and/or drug dependence.
Potential participants were invited to contact the
research assistant for further information. The information
packs were sent out monthly initially to all patients cur-
rently receiving care from the service and subsequently to
all new admissions over the recruitment period. Once the
participants returned a completed questionnaire booklet
containing the study measures and a consent form, they
were randomized into either a treatment or control group.
Patients were informed of this via a letter (UC group) or a
phone call (treatment group). Randomization was con-
ducted by the study biostatistician using a computerized
program.
Research design
Because this was a clinical effectiveness trial, its design was
clinically pragmatic. Patients with a diagnosis of bipolar
disorder receiving treatment from community mental
health services were randomized to either UC or the inter-
vention group which received SSC in addition to UC (SSC
+ UC). Baseline data related to self-efficacy, general func-
tioning, manic and depressive symptoms were collected on
entry to the study and then repeated at 9 months. Data
were collected between August 2008 and July 2010.
Usual care
Patients randomized into the control group continued
to receive usual treatment (psychiatric and nursing care)
provided by their community mental health service.
Specialist supportive care + usual care
Patients randomized to the intervention group received SSC
+ UC for 9 months delivered by two community mental
health nurses trained in delivery of the intervention and
supervised by an experienced research therapist. This inter-
vention was delivered in parallel with the patients’ UC but
was not integrated into the clinical service, e.g. the thera-
pist did not attend team meetings in which patient care was
determined. Patients received SSC in 50-min sessions on a
weekly basis for the initial 2 months and then fortnightly.
448
Each session was audio-taped to assess treatment fidelity
and therapist competence. Patients in the intervention
group completed questionnaire booklets before and after
receiving SSC.
Supervision
The two nurse therapists were trained and supervised by a
therapist experienced in the delivery of SSC for bipolar
disorder in a research setting. All therapy sessions were
digitally recorded and made available for fortnightly super-
vision sessions. The supervisor listened to recordings of the
first and every fifth session to ensure treatment fidelity and
therapist competence.
Intervention
Specialist supportive care
Specialist supportive care is a modification of a therapy
originally designed for depression (Fawcett et al. 1987,
Joyce 2004) but remodelled specifically for use in bipolar
disorder. The primary goals of SSC are to develop and
maintain a therapeutic relationship between patient and
clinician that promotes adherence to their treatment regime
and to problem-solving strategies for managing the impact
of bipolar disorder on their life and relationships based on
a collaboratively developed clinical formulation.
Specific aims include:
• assisting the patient to come to terms with having a
long-term condition;
• providing education and advice about bipolar
disorder;
• exploring issues related to medication adherence;
• promoting awareness and recognition of triggers and
early warning signs of relapse;
• providing support for the patient’s psychological
adaptive defences while challenging unrealistic
beliefs;
• promoting the patient’s sense of safety and
self-esteem;
• encouraging the patient’s strengths and decision-
making capacity;
• focusing on the ‘here and now’.
Two specific strategies are incorporated into the
therapy: a timeline is developed to identify the history of
the patient’s mood symptoms and their relationship to
significant life and developmental events; and a clinical
formulation is developed in collaboration with the patient
to provide a focus for subsequent sessions.
The psychotherapy is structured into three stages. The
initial stage is focused upon understanding the patient’s
experience of bipolar disorder over the course of their life
and their response to having bipolar disorder. A timeline is
© 2011 Blackwell Publishing

used to create a visual record of important life events, their
impact upon the person and the relationship of life events
to mood episodes. A genogram is also used to gain an
understanding of the important people in a person’s life
and the nature or quality of these relationships. The infor-
mation gained is then developed into a clinical formulation
as described by Crowe et al. (2008), which when used for
bipolar disorder includes:
• a history of their mood difficulties and treatments;
• significant life events;
• triggers to mood change;
• attitude to bipolar;
• consideration of what may be contributing to any
ongoing mood instability;
• strengths of the person in relation to the way they
manage or live with bipolar;
• potential issues for therapy and why.
In the middle stage therapy sessions move to fortnightly
and in this phase are patient-driven and dependent upon
the goals developed in the clinical formulation. The patient
initiates the focus for each session. The final stage involves
reviewing progress and the goals of therapy and having a
focus upon the future.
Ethical considerations
Ethical approval was obtained from the New Zealand Min-
istry of Health, Upper South A Regional Ethics Committee
before recruitment of participants. All participants were
supplied with an information sheet explaining the study in
detail as well as the opportunity to contact the researcher
for any questions or comments. Return of a completed
questionnaire was considered consent for the control group
participants. Treatment group patients were required to
sign a consent form before commencement of therapy. The
process of consent was discussed with each patient includ-
ing confidentiality and anonymity as required by the
Regional Ethics Committee. All participants were assured
of their ability to withdraw consent at any time. Question-
naire data and any identifying information were handled
with the strictest confidentiality and stored securely.
Outcome measures
Feasibility
The study was designed to recruit 72 patients diagnosed by
a psychiatrist with bipolar I or bipolar II disorder randomly
selected from case lists of the four community mental
health services and invited to participate in the study. Inclu-
sion criteria were: (1) age 18+ years, and (2) able and
willing to sign informed consent for the research protocol.
A sample size of 36 individuals per group would ensure
© 2011 Blackwell Publishing
SSC for bipolar disorder
that at least 33 had adequate data for analysis at 9 months.
This sample size of 33 per group would ensure that effect
sizes >0.7 would be detected as statistically significant
(two-tailed a = 0.05) with at least 80% power.
Depression and mania
The Symptom Check List (SCL-90) (Derogatis & Cleary
1977) is one of the most widely used self-report psychomet-
ric instruments in clinical practice and research. It is
designed to measure a broad range of psychological prob-
lems and symptoms of psychopathology. SCL-90 explores
nine primary symptom dimensions and is useful in measur-
ing patient progress or treatment outcomes. In our study the
SCL-90 was adapted to measure depressive and manic
symptoms only by extracting two of the nine symptoms
sub-scales. Five questions for depression (questions: 15, 30,
32, 54, 71) and six for mania (questions: 8a, 17a, 21a, 47a,
80a, 84a) were used. The patient rates the level to which they
have been bothered by symptoms during the past week.
Each item is scored on a 5-point scale with 0 = not at all and
4 = extremely. The final score on the sub-scale is achieved by
adding up the scores of all the items and dividing by the
number of items giving a score between 1 and 4.
Self-efficacy
To measure self-efficacy for managing bipolar symptoms,
the Bipolar Self-efficacy Scale (Centre for Clinical Interven-
tions 2008) was used. The scale was developed specifically
to investigate bipolar patients’ self-efficacy beliefs relating
to the management of their illness and to explore the role
of these beliefs on illness outcome. The measure covers
domains which are common for many chronic conditions
including symptom control (taking medication and recog-
nizing stressors and early warning signs), role functioning,
emotional functioning and communication with physicians.
Higher scores indicate higher self-efficacy.
General physical health and functioning
The 12-item Short-Form Health Survey (SF-12v2) (Ware
1994) was used to measure general health status. SF-12v2
consists of eight sub-scales exploring: general health, vital-
ity, bodily pain, mental health, physical functioning, social
functioning, emotional role functioning and physical role
functioning. These are compiled into two summary mea-
sures, the physical health component summary (PCS) and
mental health component summary (MCS). The summary
scores range from 0 to 100, where higher scores indicate
higher levels of functioning.
Analyses
Frequencies and percentages were conducted for the demo-
graphic and clinical characteristics of the sample. Means
449
M. Crowe et al.

and standard deviations were conducted for age. Chi-
squared analyses were used to determine if there were any
differences in demographic and clinical characteristics of
the groups.
Independent t-tests were used to identify any differences
in the UC group and SSC + UC group at baseline and end
of treatment on the outcome variables of depressive symp-
toms, manic symptoms, self-efficacy, PCS and MCS.
Primary analyses were performed on the intention-to-treat
basis for the SSC + UC group. However, additional analy-
ses were also performed comparing UC with those in the
SSC + UC group who completed therapy. Where there was
no end of treatment data, the baseline scores were carried
over for the analyses.
Results
Information sheets, consent forms and questionnaires were
sent out to 205 patients with a diagnosis of bipolar I or II
disorder currently under treatment with community mental
health services. Following this recruitment process, 78
patients (38%) returned their completed questionnaire
booklet and consent form. Of the 78 participants, 42 were
assigned to the UC group and 36 to the SSC + UC group.
Of the 36 patients who were randomized to the SSC +
UC group, 15 declined the intervention (42%) and 21
commenced therapy with 14 completing (39%) and seven
withdrawing (19%) from therapy. Of the 14 who com-
pleted therapy, there was an average of 17 completed
sessions (range 9–22). Those participants that withdrew
from therapy had an average of five sessions (range 1–7
sessions). The completion rate once participants had
engaged in the intervention was 67%.
The mean age of the participants in the total sample was
43.3 (⫾11.6) years. The SSC + UC group had a mean age
of 40.7 (⫾12.2) years, while the mean age of the UC group
was 45.5 (⫾10.8). The total sample was 53% female and
predominantly New Zealand European (85%). Thirty-six
per cent of the sample was single, 37% separated or
divorced, with 15% married. The majority were beneficia-
ries (58%) with 27% in employment outside of home
(either full- or part-time). There were no significant differ-
ences in any of the demographic characteristics of the
groups. Episodes of depression and mania in the previous 9
months were prevalent in both SSC + UC and the UC
groups, as were previous hospitalizations for mania and
depression. There were no statistically significant differ-
ences in these clinical characteristics between the groups
(see Table 1).
There were also no statistical differences in baseline
scores in the mania and depression scales of the SCL-90.
Nor were there any differences in self-efficacy ratings or
PCS and MCS scores from the SF-12 (see Table 2).
The primary analyses were undertaken on an intention-
to-treat basis, thus the SSC + UC group comprised of all the
participants randomized to SSC + UC even if they declined
the intervention or dropped out of therapy. Differences
in mean scores for mood (both depression and mania),

Table 1
Demographic and clinical characteristics of sample
Total (n = 78) Usual care + SSC (n = 36) Usual care (n = 42)
Demographic characteristics n (%) n (%) n (%)
Gender
Female 53 (68) 28 (78) 25 (60)
Ethnicity
New Zealand European 66 (85) 29 (81) 37 (88)
Maori 3 (4) 0 3 (7)
Other 9 (12) 7 (19) 2 (5)
Marital status
Single 28 (36) 12 (33) 16 (38)
Separated/divorced 29 (37) 13 (36) 16 (38)
Married 15 (19) 9 (25) 6 (14)
Other 6 (8) 2 (6) 4 (10)
Job status
Employed outside home (full-time or part-time) 21 (27) 10 (28) 11 (26)
Beneficiary 45 (58) 18 (50) 27 (64)
Homemaker 6 (8) 4 (11) 2 (5)
Other (self-employed, retired, other) 6 (8) 4 (11) 2 (5)
Clinical characteristics
Episode of mania in previous 9 months, n = 76 51 (65) 24 (67) 27 (64)
Episode of depression in previous 9 months, n = 77 55 (71) 22 (61) 33 (79)
Ever been hospitalized for mania, n = 77 55 (71) 26 (72) 29 (69)
Ever been hospitalized for depression, n = 77 42 (54) 16 (44) 26 (62)
Well >50% of time, n = 74 34 (46) 20 (59) 14 (35)
SSC, specialist supportive care.

450 © 2011 Blackwell Publishing

 SSC for bipolar disorder

Table 2
Independent t-tests comparing baseline scores for mood, self-efficacy, physical health and mental health functioning for usual care and usual
care + SSC
Baseline usual care (n = 42) Baseline usual care + SSC (n = 36)
Mean (SE) Mean (SE)
Mania scores 0.87 (0.11) 0.93 (0.15)
Depression scores 1.43 (0.14) 1.19 (0.17)
Self-efficacy scores 7.07 (0.37) 7.39 (0.69)
n = 39 n = 34
Physical health component score 47.30 (1.81) 50.90 (1.60)
Mental health component score 38.00 (1.56) 40.44 (2.16)
SSC, specialist supportive care.

Table 3
Independent t-tests comparing differences in baseline and end of treatment scores in mood, self-efficacy, physical health and mental health
functioning in usual care versus intention-to-treat specialist supportive care (SSC) + usual care
Usual care (n = 42) Usual care + SSC (n = 36)
Mean (SE) Mean (SE) P
Difference in mania scores 0.004 (0.06) 0.01 (0.11) 0.97
Difference in depression scores 0.08 (0.11) -0.07 (0.11) 0.30
Difference in self-efficacy scores 0.08 (0.29) 0.83 (0.21) 0.99
n = 39 n = 34
Difference in physical health component score -0.87 (0.83) -0.30 (0.92) 0.64
Difference in mental health component score -0.55 (1.03) 0.36 (1.17) 0.56

Table 4
Independent t-tests comparing differences in baseline and end of treatment scores in mood, self-efficacy, physical health and mental health
functioning in usual care versus specialist supportive care (SSC) + usual care treatment completers
Usual care (n = 42) Completers of usual care + SSC (n = 14)
Mean (SE) Mean (SE) P
Difference in mania scores 0.004 (0.07) 0.31 (0.22) 0.22
Difference in depression scores 0.09 (0.11) -0.27 (0.24) 0.12
Difference in self-efficacy scores 0.81 (0.29) -0.21 (0.23) 0.58
n = 39 n = 14
Difference in physical health component score -0.87 (0.83) 0.50 (1.84) 0.44
Difference in mental health component score -0.55 (1.03) 1.92 (2.71) 0.41

self-efficacy, and PCS and MCS between baseline and end
of treatment were calculated. Independent t-test did not
demonstrate any statistical differences between the groups
(see Table 3).
Further independent t-tests were conducted comparing
the differences in the baseline and end of treatment mean
scores for mood (both depression and mania), self-efficacy,
and PCS and MCS group in the UC and with those in the
SSC + UC who had completed therapy. Again, no statisti-
cally significant differences were identified between the
groups (see Table 4).
Discussion
Bauer et al. (2001) have identified key principles for the
design of an effectiveness study to ensure its external and
internal validity: (1) the sample should reflect the target
population to which the results will be generalized; (2) the
intervention should be widely implementable in the target
practice venues; (3) the research data collection load should
be as low and as flexible as possible; and (4) data analysis
procedures should account for data not missing at random
and take into account sample heterogeneity. Our study
addressed these key principles, but the analysis was unable
to meaningfully covary sample attributes, e.g. co-morbidity
and number of previous episodes because of the small
numbers of those who engaged in the intervention. This
was primarily a feasibility study with a small size compared
to other larger studies. This excluded analyses of specific
subgroups, e.g. those with co-morbid personality disorder,
anxiety disorder, eating disorder or moderate alcohol and
drug dependence. However, because the exclusion criteria
were limited to severe alcohol and/or drug dependence, the
sample was generally representative of those in clinical care
at the time of the study and did not exclude subgroups
usually excluded from efficacy studies.
The key findings from this feasibility study using clini-
cally complex patients typical of those treated in commu-

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M. Crowe et al.
nity mental health services identified challenges in engaging
patients in psychotherapy. We were able to recruit 38% of
current patients of a community mental health service with
a diagnosis of bipolar disorder. Of those randomized to
psychotherapy (SSC + UC), 58% engaged in therapy and
39% completed therapy. However, of those who engaged in
therapy, 67% went on to complete therapy. These findings
would suggest that the challenge was predominantly in
engagement in therapy because once engaged these patients
tended to continue in therapy.
Randomized controlled trials are difficult to conduct in
real-life clinical settings for many reasons. Patients who
were recruited were all receiving treatment from specialist
mental health services and were all in a current mood
episode. While many patients were willing to fill in ques-
tionnaires for the study, 42% did not want to commit to a
9-month psychotherapy. There were a range of possible
reasons for this: patients did not want to remain under
treatment from the service for that length of time; patients
did not wish to disrupt UC arrangements; patients may
have been wary about what they would be expected to do
in therapy; and patients may have been too unwell to
engage with a structured therapy. Thirty-one patients in the
control group completed both baseline and follow-up ques-
tionnaires (74%). This response rate suggests that patients
are motivated to participate in a control group of a ran-
domized controlled study. The 11 patients who did not
complete the follow-up measures were generally unable to
be located.
While some patients who were randomized to the
therapy group did not want to commit to therapy, some in
the control group were disappointed that they had not been
randomized to therapy. Some patients did not want to
disrupt their UC arrangements. Despite approval from the
service and the provision of multiple information sessions
and because the intervention was being offered in parallel
to usual service delivery, it is not clear whether all clinicians
supported and/or promoted a formalized therapy as dis-
tinct to a more generic form of therapy offered within the
service. It may also have been perceived as a threat to UC
arrangements. There was resistance from some clinicians
who wanted to choose the intervention for their patients
and to decide who was suitable for therapy.
The timing of the intervention may not have been
optimal with all participants in episode when recruited and
most participants have had treatment for bipolar disorder
for many years. Scott et al. (2006a) found in a meta-
analysis of psychological interventions for bipolar disor-
ders that those that entered therapy while euthymic had a
lower risk of relapse than those using usual psychiatric
care. This was not the case for those who entered therapy
at an early point in their recovery or during an acute
452
episode. They also found that patients who had a history of
multiple relapses (ⱖ12) showed no additional benefit from
adjunctive therapy as compared with usual treatment.
The participants in our study were all in current mood
episode. Scott & Colom (2008) have identified published
randomized controlled trials indicate differences in the
mental state of participants at the time of entry. Their
meta-analysis identified that subjects receiving adjunctive
therapy who had been euthymic for more than a year had
a significantly lower risk of relapse than those receiving
usual psychiatric treatment. This was not the case for those
subjects who commenced therapy at an early point in their
recovery or commenced therapy during an acute episode.
Miklowitz (2008) has suggested that mood state at entry
may moderate the effectiveness of certain therapies. Rizvi
& Zaretsky (2007) have also identified that the impact of
psychotherapy appears to be dependent on the severity of
the episode.
Even under controlled research conditions, the median
number of sessions attended by participants in many ran-
domized controlled trials is about 66% (Lam et al. 2003).
The non-adherence rates with therapy are similar to non-
adherence rates with medication (Scott & Colom 2008).
The completion rate in our study (67% of those who had
commenced therapy) was comparable with studies of the
efficacy of psychotherapies for bipolar disorder (Miklowitz
et al. 2007).
In regard to the second aim of the study, those received
SSC + UC did not have improved self-efficacy and func-
tioning or less depressive symptoms as was anticipated.
This lack of positive outcome has also been previously
reported in a large-scale clinical effectiveness study of cog-
nitive behavioural therapy for bipolar disorder (Scott et al.
2006b) that also recruited patients with complex and recur-
rent presentations of bipolar disorders in multiple clinical
sites throughout England, and found that the intervention
did not reduce relapses. These findings likely reflect the
challenges associated with clinical effectiveness trials that
have been identified. Most previous studies have reported
treatment efficacy in less clinically representative samples
(e.g. Lam et al. 2003, Frank et al. 2005) and with patients
who were euthymic on entry (e.g. Perry et al. 1999, Colom
et al. 2003).
Our study demonstrated that while recruitment and par-
allel delivery of a disorder-specific intervention alongside
UC was feasible, the rate at which patients chose to engage
in the therapy affected the possibility of demonstrating
meaningful outcomes. It is also possible that the duration
of the intervention was insufficient for this particular group
of patients who were still in episode because it has been
noted that further research is needed to establish whether
those individuals with more complex presentations require
© 2011 Blackwell Publishing
 SSC for bipolar disorder

a longer course of therapy (Scott 2006). The attrition rate
for those in the intervention group (34%) was similar to
that in other therapy studies (35.6%) (Miklowitz et al.
2007), which suggests that the therapy was generally
acceptable to patients. However, it does highlight the need
for further understanding of factors which influenced
patients not to engage in therapy. The delivery of the inter-
vention and collection of data from both groups was fea-
sible; however, the way in which the intervention was
delivered needs to be addressed. There needs to be particu-
lar attention to the timing of the intervention, particularly
the clinical status of the patient at the time of engaging in
therapy. The choice of intervention SSC + U may also not
have been the most effective for this group of patients.
While there is some evidence about what is common to
treatments with demonstrated efficacy, it is not known
which specific strategies are essential to stabilizing patients
with bipolar depression or mania, how long patients must
be exposed to these interventions or whether the strategies
should vary with the clinical presentation or illness history
of the patient (Miklowitz & Scott 2009).
Conclusion
As Fleischaker & Goodwin (2009) have observed, the
closer to real life an effectiveness study becomes, the less it
offers in confidence of efficacy. The findings from this fea-
sibility study suggest that a pragmatic study of the clinical
effectiveness of disorder-specific interventions for bipolar
disorder needs to address the issue of patient choice to
engage in therapy. Attention to the timing of therapy is
needed whereby therapy maybe more effective to instigate
when the patient is not in a current mood episode. It may
also mean that any disorder-specific psychosocial interven-
tion needs to be integrated into the model of service deliv-
ery, not an adjunct delivered in parallel. An integrated team
approach that utilizes a structured disorder-specific psycho-
social intervention with proven efficacy in acute and main-
tenance stages of the disorder, e.g. interpersonal social
rhythm therapy (Frank et al. 2005), may be more effective
for this group of patients. An integrated approach that
provides an integrated pharmacological and psychosocial
treatment would potentially promote patient willingness to
engage in therapy.
Acknowledgments
We wish to acknowledge all those patients who took part in
this study for their contribution to the development of
effective treatments for bipolar disorder. We also wish to
thank all staff in the community mental health service, but
particularly the assistance provided by Mr Craig Cowie.

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