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Psychological interventions for avoidant personality disorder

(Protocol)

Ahmed U, Gibbon S, Jones H, Huband N, Ferriter M, Völlm BA, Stoffers JM, Lieb K, Dennis
JA, Duggan C

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2012, Issue 1
http://www.thecochranelibrary.com

Psychological interventions for avoidant personality disorder (Protocol)


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Psychological interventions for avoidant personality disorder (Protocol) i


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Psychological interventions for avoidant personality disorder

Uzair Ahmed1 , Simon Gibbon2 , Hannah Jones3 , Nick Huband4 , Michael Ferriter5 , Birgit A Völlm4 , Jutta M Stoffers6,7 , Klaus Lieb
7
, Jane A Dennis8 , Conor Duggan4

1 North Yorkshire
and York PCT, York, UK. 2 St Andrew’s Healthcare, Northampton, UK. 3 Cochrane Schizophrenia Group, University
of Nottingham, Nottingham, UK. 4 Forensic Mental Health, Institute of Mental Health, University of Nottingham Innovation Park,
Nottingham, UK. 5 Forensic Division, Nottinghamshire Healthcare NHS Trust, Woodbeck, UK. 6 Department of Psychiatry and
Psychotherapy, University Medical Center Freiburg, Freiburg, Germany. 7 Department of Psychiatry and Psychotherapy, University
Medical Center Mainz, Mainz, Germany. 8 c/o Developmental, Psychosocial and Learning Problems Group, Queen’s University, Belfast,
UK

Contact address: Michael Ferriter, Forensic Division, Nottinghamshire Healthcare NHS Trust, The Clair Chilvers Centre, Rampton
Hospital, Woodbeck, Nottinghamshire, DN22 0PD, UK. Michael.Ferriter@nottshc.nhs.uk.

Editorial group: Cochrane Developmental, Psychosocial and Learning Problems Group.


Publication status and date: New, published in Issue 1, 2012.

Citation: Ahmed U, Gibbon S, Jones H, Huband N, Ferriter M, Völlm BA, Stoffers JM, Lieb K, Dennis JA, Duggan C. Psychological
interventions for avoidant personality disorder. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD009549. DOI:
10.1002/14651858.CD009549.

Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

This is the protocol for a review and there is no abstract. The objectives are as follows:

This review aims to evaluate the potential beneficial and adverse effects of psychological interventions for people with avoidant
personality disorder.

BACKGROUND hood and present in a variety of contexts, as indicated by four (or


more) of the following:
(1) avoids occupational activities that involve significant interper-
sonal contact because of fears of criticism, disapproval or rejec-
Description of the condition tion.
(2) is unwilling to get involved with people unless certain of being
A personality disorder is “an enduring pattern of inner experience
liked.
and behaviour that deviates markedly from the expectations of the
(3) shows restraint within intimate relationships because of the
person’s culture, is pervasive and inflexible, has an onset in adoles-
fear of being shamed or ridiculed.
cence or early adulthood, is stable over time and leads to distress or
(4) is preoccupied with being criticised or rejected in social situa-
impairment”, according to the Diagnostic and Statistical Manual
tions.
of Mental Disorders (DSM-IV-TR) (APA 2000). Avoidant per-
(5) is inhibited in new interpersonal situations because of feelings
sonality disorder is characterised by DSM-IV-TR (APA 2000) as “a
of inadequacy.
pervasive pattern of social inhibition, feelings of inadequacy, and
(6) views self as socially inept, personally unappealing, or inferior
hypersensitivity to negative evaluation, beginning in early adult-
Psychological interventions for avoidant personality disorder (Protocol) 1
Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
to others. Holt 1992; Turner 1992). Zanni 2007 found personality disorder
(7) is unusually reluctant to take personal risks or to engage in any symptoms may change with age; some symptoms can become less
new activities because they may prove embarrassing.” prominent while others become worse.
DSM-IV-TR also comments on the overlap between avoidant per- The prognosis for avoidant personality disorder is quite poor as
sonality disorder and social phobia (generalised type) and suggest individual habits and attitudes are often pervasive and ingrained,
that they may be alternative conceptualisations of the same or sim- with many lacking the support and encouragement they need to
ilar condition. Interestingly, Mendlowicz 2006 noted an increase improve their lifestyle (Millon 1996). Skodol 2005 and Newton-
in papers published on social phobia from 1973 to 2001, with Howes 2006 found a personality disorder that co-occurs with an
a decrease in publications on avoidant personality disorder over Axis-I disorder may have a negative impact on the outcome of the
the same period. However, it is also worth noting that the current latter. Percudani 2002 found a higher probability of these patients
draft of the fifth edition of the Diagnostic and Statistical Manual withdrawing from treatment. Other studies suggest individuals
of Mental Disorders (DSM-V), which will be published in 2013, with personality disorders are less likely to make contact with
recommends retaining social phobia as a diagnosis and reformu- psychiatric services compared with those with other conditions
lating avoidant personality disorder as avoidant type (APA 2010). such as schizophrenia or depression (Andrews 2001). They are
The International Classification of Mental and Behavioural Dis- often not recognised by professionals and they do not seek help
orders (ICD-10) (World Health Organization 1992) refers to this (Herbert 2004).
disorder as “anxious (avoidant) personality disorder” and describes
much the same characteristics as DSM-IV-TR but requires only
three of the behaviours to be present in order to qualify for a di- Description of the intervention
agnosis.
Avoidant personality traits are common but a diagnosis of avoidant Psychological therapies encompass a wide range of interventions
personality disorder is only made when these are inflexible, mal- (Bateman 2004) including psychoanalytic psychotherapy, cogni-
adaptive and persist to an extent that causes significant impair- tive therapy, therapeutic communities and nidotherapy. The gen-
ment or distress to the individual (APA 2000). eral goal of treatment in avoidant personality disorder is improve-
Togersen 2001 found avoidant personality disorder to be the most ment of self-esteem and confidence. As the individuals’ self-con-
common personality disorder in a large community-based sample, fidence and social skills improve, they will become more resilient
with prevalence rates of 5%. In clinical samples, the disorder is to potential or real criticism by others.
thought to be present in about 10% of outpatients (APA 2000). It is important to consider all relevant studies without restriction
Coid 2003 summarised the findings of various community sur- on the type of psychological therapy and to consider psychological
veys and reported prevalence ranges from 0.8% to 5% with high interventions where drugs are also given as an adjunctive inter-
comorbidity. However, subsequently, Coid 2006 found a much vention. Individual and group therapeutic interventions may be
lower prevalence rate of 0.8% in a household survey of 626 par- used, although the nature of avoidant personality disorder itself
ticipants. may make group therapy less common.
The aetiology of avoidant personality disorder is unknown, but re-
search suggests there are a number of biological and psychological
factors (Dalrymple 2007). Biological factors include neurochem- How the intervention might work
ical abnormalities such as serotonergic system deficits (Cloninger
Psychoanalytic therapies (which include dynamic psychotherapy,
1986), familial and genetic transmission (Cloninger 1986) and
transference-focused psychotherapy, mentalisation and group psy-
inborn temperament, for example, a tendency to retreat from un-
chotherapy) aim to help the patient understand and reflect on his
familiar situations (Kagan 1989). Psychological factors have also
inner mental processes and make links between his past and his
been found to play their part in the development and maintenance
current difficulties.
of avoidant personality disorder. Examples of this would include
Cognitive analytic therapy (CAT) is a brief psychological therapy
childhood experiences (for example, pathological parenting such
utilising ideas from psychodynamic psychotherapy, cognitive ther-
as parental rejection (Beck 1990)); cognitive biases similar to those
apy and cognitive psychology (Denman 2001). Current coping
seen in social anxiety disorder (for example, memory and interpre-
strategies are looked at in detail and are adapted to bring about
tation biases) (Hirsch 2004), and social skills deficits (for example,
change through the client’s strengths, resources and tools.
avoidance of a range of social situations).
Treatments based on cognitive behavioural therapy (CBT) place
Kaplan 2005 found avoidant personality disorder to be associ-
emphasis on encouraging the patient to challenge their core beliefs.
ated with severe occupational and social impairment. In clinical
A review of the evidence for this form of intervention concluded
samples, avoidant personality disorder is often comorbid with de-
that “the overall evidence in favour of cognitive behavioural ther-
pendant personality disorder, anxiety disorders (especially social
apy in the treatment of personality disorder is therefore relatively
phobia, generalised type) and depressive episodes (Herbert 1992;
slim, with much of the evidence coming from one research group,

Psychological interventions for avoidant personality disorder (Protocol) 2


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
but it has involved more patients than any other form of treat- OBJECTIVES
ment” (Bateman 2004).
Dialectical behavioural therapy (DBT) is a complex psychological This review aims to evaluate the potential beneficial and adverse
intervention that was developed using some of the principles of effects of psychological interventions for people with avoidant per-
CBT (Linehan 1993) and may help change behaviour by improv- sonality disorder.
ing skills and the ability to contain difficult feelings. It is currently
popular, but the evidence for its efficacy is less clear with some
reviewers considering that its only proven benefit appears to be in METHODS
the reduction of self-harm episodes (Bateman 2004).
Therapeutic community treatments involve participants (also
known as residents) not only having therapy together but also
working and living together in a shared, therapeutic environment. Criteria for considering studies for this review
This provides them with an opportunity to “explore intrapsychic
and interpersonal problems and find more constructive ways of
dealing with distress” (Campling 2001). Therapeutic community
treatment is the only single treatment modality for severe personal- Types of studies
ity disorder that has been subject to a meta-analysis of randomised Controlled trials in which participants have been randomly allo-
controlled trials. This demonstrated the effectiveness of therapeu- cated to an experimental group and a control group, where the
tic community treatment (Lees 1999), but specific personality dis- control condition is either treatment as usual, waiting list or no
orders were not identified. treatment. We will include all relevant randomised controlled tri-
Nidotherapy is a formalised, planned method for achieving en- als with or without blinding of the assessors.
vironmental change to minimise the effect of the disorder both
upon those with the diagnosis and those around them. The ef-
fectiveness of this treatment has not yet been established. Unlike
Types of participants
most other therapies, it aims to fit the immediate environment to
the individual rather than change the individual to cope in the Men or women 18 years or over with a diagnosis of avoidant
existing environment (Tyrer 2007). Whilst the eventual outcome personality disorder defined by any operational criteria such as
of nidotherapy is environmental manipulation, it may be regarded DSM-IV. We will include studies of people diagnosed with comor-
as a psychological intervention in that it relies upon first devel- bid personality disorders or other mental health problems other
oping a psychological understanding of the person’s strengths and than the major functional mental illnesses (that is schizophrenia,
difficulties. The psychological formulation leads to goal setting, schizoaffective disorder or bipolar disorder). The decision to ex-
from which flows the necessary changes in the physical and social clude persons with comorbid major functional illness is based on
environment (Tyrer 2005). the rationale that the presence of such disorders (and the possible
confounding effects of any associated management or treatment)
might obscure whatever other psychopathology (including per-
sonality disorder) might be present.

Why it is important to do this review


Despite avoidant personality disorder being one of the most com- Types of interventions
mon personality disorders and having considerable impact on in- We will include studies of individual and group psychological in-
dividuals and their families, it is interesting that relatively few stud- terventions. Psychological interventions will be subclassified into
ies have examined the treatment of individuals specifically selected single modality and complex psychological interventions. Sin-
for avoidant personality disorder (Alden 2002). Evidence for the gle modality psychological interventions are those that only in-
efficacy of psychodynamic psychotherapy for personality disorders volve one specific type of intervention. Complex psychological
comes from Piper 1993, Winston 1994 and Bateman 2001. One interventions are those that involve more than one modality of
study by Emmelkamp 2006 found CBT to be more effective than treatment, for example, group therapy plus individual therapy
Brief Dynamic Therapy (BDT) for treating avoidant personality (Campbell 2000). We will include studies of psychological inter-
disorder, although methodological shortcomings with this study ventions where medication is given as an adjunctive intervention,
have been found (Leichsenring 2007). There has been an increased but will report any studies where the comparison is between a psy-
interest in developing and evaluating psychological treatments for chological and a pharmacological intervention separately. We will
personality disorders in recent years, suggesting that a systematic not include studies comparing two or more different therapeutic
review is now timely to assess the quality of available evidence. modality groups but without a control group.

Psychological interventions for avoidant personality disorder (Protocol) 3


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of outcome measures • Leaving the study early: measured as a proportion of
Primary and secondary outcomes are listed below in terms of single participants discontinuing treatment from the point of
constructs. We anticipate that a range of outcome measures will randomisation.
have been used in the studies included in the review, for example, • Employment status: measured as number of days in
avoidance may be measured by self report scales or by an external employment over the assessment period.
observer. Whilst we acknowledge that the nature of avoidant per-
sonality disorder can lead to difficulty in long-term follow-up, we
will report relevant outcomes without restriction on the period of Search methods for identification of studies
follow-up.

Electronic searches
Primary outcomes
We will search the electronic databases listed below.
• Avoidance symptoms: improvement in avoidant behaviour
• Cochrane Central Register of Controlled Trials
as measured on validated clinical scales such as the Structured
(CENTRAL), part of the Cochrane Library
Clinical Interview for DSM-IV Axis II Personality Disorders
• MEDLINE
(SCID-II) (First 1997) or the Structured Interview for DSM-IV
• EMBASE
Personality (SIDP-IV) (Pfohl 1997), or self report measures such
• CINAHL
as the NEO Personality Inventory (NEO-PI-R)/NEO Five-
• PsycINFO
Factor Inventory (NEO-FFI) (Costa 1992) or Millon Clinical
• ASSIA
Multiaxial Inventory-III (MCMI-III) (Millon 1994).
• BIOSIS
• Global state/functioning: as measured through
• Dissertation Abstracts
improvement on the Global Assessment of Functioning numeric
• National Criminal Justice Reference Service Abstracts
scale (GAF) (APA 2000), Clinical Global Impression of Severity
• Science Citation Index (SCI)
scale (CGI-S) (Guy 1976), Symptom Checklist-90 (SCL-90R)
• Social Sciences Citation Index (SSCI)
(Derogatis 1994) or similar validated scales.
• Sociological Abstracts
• Social functioning: as measured through improvement on
• ZETOC (Conference search)
the Social Adjustment Scale (SAS-SR) (Weissman 1976), the
• metaRegister of Controlled Trials
Social Functioning Questionnaire (SFQ) (Tyrer 2005) or similar
validated scales. We will base the searches on the following MEDLINE search strat-
• Adverse events: incidence of overall adverse events and of egy, which includes the Cochrane highly sensitive search strategy
the three most common adverse events; dichotomous outcome, for identifying randomised trials (Lefebvre 2008). The strategy
measured as numbers reporting. includes search terms for all types of personality disorder as this
is one of a series of PD reviews. We will modify the search terms
and syntax as necessary for other databases.
Secondary outcomes
• Quality of life: self-reported improvement in overall quality 1 exp Personality Disorders/
of life measured through improvement in scores on the European 2 (moral adj2 insanity).tw.
Quality of Life instrument (EuroQol) (EuroQoL 1990), SF36 3 (DSM and (axis and II)).tw.
(Ware 1993) or similar validated scales. 4 (ICD and (F60 or F61 or F62)).tw.
• Engagement with services: health-seeking engagement with 5 ((odd$ or eccentric$ or dramatic$ or emotional$ or anxious$ or
services measured though improvement on the Service fearful$) adj5 cluster$).tw.
Engagement Scale (SES) (Tait 2002) or similar validated scales. 6 (“Cluster A” or “Cluster B” or “Cluster C”).tw.
• Anxiety symptoms: improvement in anxiety symptoms 7 ((aggressiv$ or anxious$ or borderline$ or dependent$ or emo-
measured on the State-Trait Anxiety Inventory (STAI) (Spielberg tional$ or passiv$ or unstable) adj5 personalit$).tw.
1983) or similar validated scales. 8 (anankastic$ or asocial$ or avoidant$ or antisocial$ or anti-
• Depressive symptoms: improvement in depressive social$ or compulsiv$ or dissocial$ or histrionic$ or narciss$ or
symptoms measured on the Hamilton Depression Rating Scale obsessiv$ or paranoi$ or psychopath$ or sadist$ or schizoid$ or
(HAMD) (Hamilton 1969), the Beck Depression Inventory schizotyp$ or sociopath$).tw.
(BDI) (Beck 1961) or similar validated scales. 9 (personalit$ adj5 disorder$).tw.
• Satisfaction with treatment: measured through 10 character disorder$.tw.
improvement in scores on the Client Satisfaction Questionnaire 11 (anal$ adj (personalit$ or character$ or retentiv$)).tw.
(CSQ-8) (Attkisson 1982) or similar validated scales. 12 or/1-11

Psychological interventions for avoidant personality disorder (Protocol) 4


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
13 randomized controlled trial.pt. Assessment of risk of bias in included studies
14 controlled clinical trial.pt.
For each included study UA, HJ and MF will independently com-
15 randomi#ed.ab.
plete the Cochrane Collaboration’s tool for assessing risk of bias
16 placebo.ab.
(Higgins 2008, section 8.5.1). Any disagreement will be resolved
17 drug therapy.fs.
through consultation with UA. We will assess the degree to which:
18 randomly.ab.
• the allocation sequence was adequately generated (’sequence gen-
19 trial.ab.
eration’);
20 groups.ab.
• the allocation was adequately concealed (’allocation conceal-
21 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20
ment’);
22 exp animals/ not humans.sh.
• knowledge of the allocated interventions was adequately pre-
23 21 not 22
vented during the study (’blinding’);
24 12 and 23
• incomplete outcome data were adequately addressed;
• reports of the study were free of suggestion of selective outcome
reporting; and
Searching other resources
• the study was apparently free of other problems that could put
We will search the reference lists of included and excluded studies it at high risk of bias.
for additional relevant trials. We will also examine bibliographies of We will allocate each domain one of three possible categories for
systematic review articles published in the last five years to identify each of the included studies: low risk of bias, high risk of bias and
relevant studies. We will also contact authors of relevant studies to unclear risk of bias where the risk of bias is uncertain or unknown.
enquire about other sources of information and the first author of
each included study for information regarding unpublished data.

Measures of treatment effect

Data collection and analysis Where different outcome measures of the same construct are re-
ported, we will use the standardised mean difference (SMD) to
provide an overall estimate of effect size for that construct.
For dichotomous (binary) data, we will use the odds ratio (OR)
Selection of studies
with a 95% confidence interval (CI) to summarise results within
This review is one of a series of reviews about personality disorders. each study. The odds ratio is chosen because it has statistical ad-
We will carry out the selection of studies out in two stages. Four vantages relating to its sampling distribution and its suitability for
members of the review team (JS, NH, JD, MF) will read the titles modelling, and is a relative measure so can be used to combine
and abstracts independently to identify all studies carried out with studies. For continuous data, such as the measurement of impul-
participants with personality disorder, regardless of any specific siveness and aggression on a scale, we will compare the mean score
personality disorder(s) diagnosed. They will then independently for each outcome, as determined by a standardised tool, between
assess full copies of studies identified against the inclusion criteria the two groups to give a mean difference (MD), again with a 95%
for this review. We will identify not only trials with participants confidence interval. Where possible, we will make these compar-
diagnosed with avoidant personality disorder but also trials with isons at specific follow-up periods: (1) within the first month; (2)
participants having a mix of personality disorders for which data between one and six months, and (3) between six and 12 months.
on a subgroup with avoidant personality disorder may be available. Where possible, we will present endpoint data; where both end-
We will resolve uncertainties concerning the appropriateness of point and change data are available for the same outcomes, then
studies for inclusion in the review through consultation with a we will report only the former.
third author (CD). Authors will not be blinded to the name(s) of We will report continuous data that are skewed in a separate table
the study author(s), their institution(s) or publication sources at and we will not calculate treatment effect sizes to minimise the risk
any stage of the review. of applying parametric statistics to data that depart significantly
from a normal distribution. We will define skewedness as occurring
when, for a scale or measure with positive values and a minimum
Data extraction and management value of zero, the mean is less than twice the standard deviation
UA, HJ and MF will independently extract data using a data ex- (Altman 1996). We will use the mean difference (MD) where the
traction form. We will enter data into Review Manager 5.1 soft- same outcome measures are reported in more than one study. We
ware (RevMan) (Review Manager 2011). Where data are not avail- will use the standardised mean difference (SMD) where different
able in the published trial reports, we will contact the authors and outcome measures of the same construct are reported. If studies
ask them to supply the missing information. are considered to have more than one eligible outcome for a forest

Psychological interventions for avoidant personality disorder (Protocol) 5


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
plot, we would select a single outcome based on expert advice, will seek statistical advice on which of these options is the most
principally the most commonly used with the highest validity. appropriate for the study.

Unit of analysis issues Dealing with missing data


We will contact the original investigators to request any missing
data and information on whether or not it can be assumed to be
Cluster-randomised trials ’missing at random’.
Where trials have used clustered randomisation, we anticipate that For dichotomous data, we will report missing data and dropouts
study investigators would have presented their results after appro- for each included study and will report the number of participants
priately controlling for clustering effects (robust standard errors who are included in the final analysis as a proportion of all partici-
or hierarchical linear models). If it is unclear whether a cluster- pants in each study. We will provide reasons for missing data in the
randomised trial has used appropriate controls for clustering, we narrative summary and will assess the extent to which the results
will contact the study investigators for further information. Where of the review could be altered by the missing data by, for exam-
appropriate controls were not used, we will request individual par- ple, a sensitivity analysis based on consideration of ’best-case’ and
ticipant data and re-analyse data using multilevel models that con- ’worst-case’ scenarios (Gamble 2005). Here, the best-case scenario
trol for clustering. Following this, we will meta-analyse effect sizes is that where all participants with missing outcomes in the exper-
and standard errors in RevMan (Review Manager 2011) using the imental condition had good outcomes and all those with missing
generic inverse method (Higgins 2008). If appropriate controls outcomes in the control condition had poor outcomes, and the
were not used and individual participant data are not available, we worst-case scenario is the converse (Higgins 2008, section 16.2.2).
will seek statistical guidance from the Cochrane Statistical Meth- For missing continuous data, we will provide a qualitative sum-
ods Group and external experts as to which method to apply to mary. The standard deviations of the outcome measures should
the published results in attempt to control for clustering. If there be reported for each group in each trial. If these are not given, we
is insufficient information to control for clustering, we will enter will impute standard deviations using relevant data (for example,
outcome data into RevMan using individuals as the units of anal- standard deviations or correlation coefficients) from other, similar
ysis, and then we will use sensitivity analysis to assess the potential studies (Follmann 1992) but only if, after seeking statistical ad-
biasing effects of inadequately controlled clustered trials (Donner vice, to do so is deemed practical and appropriate. Where missing
2001). data might be assumed to be missing at random then it may be
appropriate to analyse only the available data. Where it may not be
possible to assume this, i.e. the data are ’not missing at random’,
Cross-over trials it might be possible to impute missing data with replacement val-
It is unlikely for cross-over trials to be used for a psychological in- ues, for example, last observation carried forward. We would only
tervention due to issues concerning a ’washout’ period. However, use other methods of imputing missing values with uncertainty or
if any cross-over trials are found and we conduct a meta-analysis using statistical models on the advice and with the assistance of a
combining the results of cross-over trials, we will use the inverse statistician.
variance methods recommended by Elbourne 2002. Where data
presented from a cross-over trial are restricted (and more informa-
tion is not available from the original investigators), we will use Assessment of heterogeneity
the presented data within the first phase only, up to the point of We will assess the extent of between-trial differences and the con-
cross-over. sistency of results of any meta-analysis in three ways: by visual
inspection of the forest plots; by performing the Chi2 test of het-
erogeneity (where a significance level less than 0.10 will be in-
Multi-arm trials terpreted as evidence of heterogeneity) and by examining the I2
We will include all eligible outcome measures for all trial arms in statistic (Higgins 2008; section 9.5.2). The I2 statistic describes
this review. Where there are more than two arms of the trial that approximately the proportion of variation in point estimates due
meet the inclusion criteria, two or more intervention arms and/or to heterogeneity rather than sampling error. We will consider I2
two or more control group arms, there are a number approaches values of less than 40% as where heterogeneity may not be im-
that can be used. These include combining arms to create one sin- portant; values in the range 30% to 60% may represent moderate
gle pair-wise comparison; selecting one pair for comparison only; heterogeneity; values in the range 50% to 90% may represent sub-
splitting the ’shared’ group into two or more groups to provide stantial heterogeneity, and 75% to 100% represents considerable
two or more comparisons; including two or more correlated com- heterogeneity.
parisons, or undertaking a multiple treatment meta-analysis. In We will attempt to identify any significant determinants of het-
the event of a multi-arm trial meeting our inclusion criteria, we erogeneity categorised as moderate or high. We cannot state in

Psychological interventions for avoidant personality disorder (Protocol) 6


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
advance what our preferred method of dealing with heterogeneity, measures by length of follow-up. Where appropriate, and if a suf-
if present, will be as this will be contingent on the data. However, ficient number of studies are found, we will use regression tech-
we will first check that the data were correctly entered. There are niques to investigate the effects of differences in the study charac-
a number of methods that can be used for handling heterogeneity teristics on the estimate of the treatment effects. We will seek statis-
and these include the following. The studies can be examined to tical advice before attempting meta-regression. If meta-regression
explore the reason for heterogeneity but this is not recommended is performed, we will execute this using a random-effects model.
where there are few studies. A random-effects model could be used.
Where a study paper is an outlier, sensitivity analysis can be carried
out with and without the study. Other strategies include ignoring Subgroup analysis and investigation of heterogeneity
the heterogeneity, not performing a meta-analysis and changing If sufficient studies are found, we will undertake subgroup analysis
the effect measure. We will seek statistical advice before using any to examine the effect on primary outcomes of:
of these methods. 1. principal diagnosis;
2. setting (inpatient, custodial, outpatient/community); and
3. psychotherapeutic method.
Assessment of reporting biases
We will draw funnel plots (effect size versus standard error) to
assess publication bias if sufficient studies are found. Asymmetry Sensitivity analysis
of the plots may indicate publication bias, although they may also If there are sufficient data, we will undertake sensitivity analyses
represent a true relationship between trial size and effect size. If to investigate the robustness of the overall findings in relation
such a relationship is identified, we will further examine the clinical to certain study characteristics. A priori sensitivity analyses are
diversity of the studies as a possible explanation (Egger 1997). planned for:
1. concealment of allocation;
2. blinding of outcome assessors; and
Data synthesis 3. extent of dropouts.
We will undertake a quantitative synthesis of the data using both
fixed-effect and random-effects models. Meta-analyses may be
conducted to combine comparable outcome measures across stud-
ies. In carrying out meta-analysis, the weight given to each study
ACKNOWLEDGEMENTS
will be the inverse of the variance so that the more precise estimates
(from larger studies with more events) are given more weight. We We would like to thank the authors of other reviews in the series
will use random-effects models because studies may include some- for their hard work establishing the methodology on which this
what different treatments or populations. We will group outcome protocol is principally based.

REFERENCES

Additional references APA 2010


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Indicates the major publication for the study

HISTORY
Protocol first published: Issue 1, 2012

CONTRIBUTIONS OF AUTHORS
UA and HJ prepared the protocol. JD, MF, NH and JS will examine and select the citations and CD will provide adjudication. JD,
MF, SG and BV will examine and select the papers and CD will adjudicate. UA, HJ and MF will extract the data, complete risk of bias
tables and enter the data. UA, SG, HJ, CD, KL and MF will write the discussion.

DECLARATIONS OF INTEREST

• Uzair Ahmed - none known.


• Simon Gibbon - none known.
• Hannah Jones - none known.
• Nick Huband - investigator in a completed randomised controlled trial of social problem-solving therapy plus psychoeducation
for people with personality disorder (Huband 2007).
• Michael Ferriter - none known.
• Birgit A Völlm - none known.
• Jutta Stoffers - none known.
• Klaus Lieb - Chair, Department of Psychiatry and Psychotherapy, University Medical Center Mainz; advisor to a planned
randomised controlled trial of Inpatient Schema therapy in patients with personality disorders.
• Jane Dennis - none known.
• Conor Duggan - Chair, UK National Institute of Clinical Excellence Committee on antisocial personality disorder; advisor to a
current randomised controlled trial of schema-focused therapy at Ashworth Special Hospital, UK; investigator in a completed
randomised controlled trial of social problem-solving therapy plus psychoeducation for people with personality disorder (Huband
2007).

Psychological interventions for avoidant personality disorder (Protocol) 10


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
SOURCES OF SUPPORT

Internal sources
• Nottinghamshire Healthcare NHS Trust, UK.
• German Federal Ministry of Education and Research. Grant no. 01KG0812, Germany.

External sources
• NHS Cochrane Collaboration Programme Grant Scheme, UK.

Psychological interventions for avoidant personality disorder (Protocol) 11


Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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