STUDY PROTOCOL Open Access
Reducing the psychosocial impact of
aphasia on mood and quality of life in
people with aphasia and the impact of
caregiving in family members through
the Aphasia Action Success Knowledge
(Aphasia ASK) program: study protocol
for a randomized controlled trial
Linda Worrall1,2
, Brooke Ryan1,2*
, Kyla Hudson1,2
, Ian Kneebone3
, Nina Simmons-Mackie1,4
, Asaduzzaman Khan2
,
Tammy Hoffmann2,5
, Emma Power1,6
, Leanne Togher1,6
and Miranda Rose1,7
Abstract
Background: People with aphasia and their family members are at high risk of experiencing post stroke
depression. The impact of early interventions on mood and quality of life for people with aphasia is unknown.
Methods/design: This study will determine whether an early intervention for both the person with aphasia after
stroke and their family members leads to better mood and quality of life outcomes for people with aphasia, and
less caregiver burden and better mental health for their family members. This is a multicenter, cluster-randomized
controlled trial. Clusters, which are represented by Health Service Districts, will be randomized to the experimental
intervention (Aphasia Action Success Knowledge Program) or an attention control (Secondary Stroke Prevention
Information Program). People with aphasia and their family members will be blinded to the study design and
treatment allocation (that is, will not know there are two arms to the study). Both arms of the study will receive
usual care in addition to either the experimental or the attention control intervention. A total of 344 people with
aphasia and their family members will be recruited. Considering a cluster size of 20, the required sample size can
be achieved from 18 clusters. However, 20 clusters will be recruited to account for the potential of cluster attrition
during the study. Primary outcome measures will be mood and quality of life of people with aphasia at 12 months
post stroke. Secondary measures will be family member outcomes assessing the impact of caregiving and mental
health, and self-reported stroke risk-related behaviors of people with aphasia.
Discussion: This is the first known program tailored for people with aphasia and their family members that aims to
prevent depression in people with aphasia by providing intervention early after the stroke.
(Continued on next page)
* Correspondence: brooke.ryan@uq.edu.au
1
National Health and Medical Research Council Centre for Clinical Research
Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane,
Australia
2
School of Health and Rehabilitation Sciences, The University of Queensland,
Brisbane, Australia
Full list of author information is available at the end of the article
© 2016 Worrall et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Worrall et al. Trials (2016) 17:153
DOI 10.1186/s13063-016-1257-9
(Continued from previous page)
Trial registration: This trial is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as
ACTRN12614000979651. Date registered: 11 September 2014.
Keywords: Aphasia, Cluster randomized controlled trial, Mood, Depression, Quality of life, Rehabilitation, Prevention
Background
The prevalence of depression after stroke is approximately
31 % [1]. Post stroke depression results in poorer functional
recovery [2], higher mortality [3], and greater
healthcare utilization [4]. An investment in psychological
care after stroke has been estimated to lead to a reduction
in health and social care costs of 37 % over 2 years [4].
Aphasia is prevalent in 31 % of first-time strokes and
is still present in 60 % of these individuals at 12 months
postonset [5]. Significant and life-altering psychosocial
consequences, including poor vocational outcomes,
changes in relationships, and social isolation, are associated
with the presence of aphasia [5–8]. The incidence
of depression after aphasia is estimated to be 62 % to
70 % and is higher than in stroke survivors who do not
have aphasia [9]. Family members of patients with aphasia
are also prone to develop depression and experience
a variety of psychosocial consequences after the onset of
aphasia [10, 11].
People with aphasia report difficulty accessing existing
mental health services, intervention programs, or support
groups that can meet their needs because of their
communication disability [12]. A Cochrane review [13]
reports a small effect size when treating post stroke depression
with antidepressants (with cautions about side effects),
but not the prevention of depression by pharmacological
means. Notably, psychological approaches have shown
promise for prevention [14]. However, the Cochrane prevention
review could not extend recommendations to
patients with aphasia since it noted that too few studies
included participants with this condition.
In recognition of the need to improve longer-term
outcomes in mood and quality of life for people with
aphasia, an intervention program called the Aphasia
Action Success Knowledge (Aphasia ASK) program has
been developed. Findings from a Phase 1 feasibility study
suggested the Aphasia ASK program had positive initial
outcomes for people with aphasia and their family members.
The Aphasia ASK program now requires evaluation
on a larger scale.
Aim
The study aim is to determine whether an early intervention,
Aphasia ASK, for the person with aphasia after
stroke and their family members leads to better mood
and quality of life outcomes for people with aphasia, less
caregiver burden, and better mental health for family
members compared to an attention-control intervention
(Secondary Stroke Prevention Information Program; SSPIP)
at 12 months post stroke.
Hypotheses
Primary hypothesis
People with aphasia who receive the Aphasia ASK intervention
will have significantly better outcomes in mood
[15] and quality of life [16] at 12 months post stroke
compared to those who receive the attention control
intervention (SSPIP).
Secondary hypothesis
Family members of people with aphasia who receive the
Aphasia ASK intervention will have significantly better
outcomes on measures of impact of caregiving [17] and
mental health [18] at 12 months post stroke than family
members who receive the attention control intervention
(SSPIP).
In addition, people with aphasia who have completed
the attention control intervention (SSPIP) are hypothesized
to have a significantly better score on a stroke riskrelated
behavior measure [19] compared to those who
receive the Aphasia ASK intervention.
Methods
Design
This is a multicenter cluster-randomized controlled trial.
Clusters, which are represented by Health Service Districts,
will be randomized to either the experimental
intervention or an attention control intervention, with
an equal number of Health Service Districts in each
arm. Usual care will continue to the intervention and
control arms. The usual care provided will be at the discretion
of the hospital site and their treatment protocols.
Usual care is typically considered as 1 to 2 sessions of
aphasia therapy per week in addition to any required
rehabilitation for other stroke-related impairments.
Documentation of usual care aphasia therapy will occur.
Eligible individuals with aphasia and their family members
will be invited to participate upon referral to speechlanguage
pathology services, commencing intervention as
early as possible in rehabilitation, but no later than
6 months post stroke. Assessments will occur at baseline
and at 12 months post stroke.
The Consolidated Standards of Reporting Trials (CONSORT)
2010 extension statement for cluster-randomized
Worrall et al. Trials (2016) 17:153 Page 2 of 7
trials [20] has been used to guide the research plan.
The Standard Protocol Items: Recommendations for
Interventional Trials (SPIRIT) 2013 statement [21] has
been used to develop the trial protocol. The Template
for Intervention Description and Replication (TIDieR)
guide [22] has been used to guide the description of the
study interventions.
Ethics approval
The trial sponsor is the University of Queensland funded
by a National Health and Medical Research Council Project
Grant from 2014-2018 [APP1060673]. The study
protocol was approved by the Darling Downs Hospital
and Health Service Human Research Ethics Committee
in Queensland, Australia. Expedited approval for the
study was also granted by the University of Queensland
on the basis of approval from the Darling Downs
Hospital and Health Service Human Research Ethics
Committee. Amendments to the protocol during the
study period will be submitted to the Darling Downs
Hospital and Health Service Human Research Ethics
Committee. Informed written consent will be obtained
from all participants before inclusion in the trial.
Clusters
Clusters for the study will be Health Service Districts
that offer speech pathology rehabilitation services as a
single operational unit across multiple site locations
within a defined service area in Australia. Health Service
Districts were chosen as clusters (instead of individual
hospital/health service sites) to reduce the risk of treatment
contamination issues that may arise from conducting
both arms of the study within the same service area.
Health Service Districts were also chosen so that the
study interventions can be provided alongside the usual
continuum of care for the study duration (that is, across
multiple health facilities within the first year post stroke).
An inclusion criterion for clusters is that they must provide
aphasia rehabilitation services, with the capacity to
provide services over the period of intervention. Clusters
will be excluded if they are participating in other clinical
trials at the time of randomization, which will limit the
recruitment capacity and/or conflict with the intervention
requirements of the current trial. Each Health
Service District will provide either the experimental or
the attention control intervention to a maximum of 20
people with aphasia plus their family members.
Participants: inclusion and exclusion criteria
Participants will be people with aphasia who are within
the first 6 months following a stroke and their family
member(s). The diagnosis of aphasia will be based on a
qualified speech pathologist’s administration of the
Western Aphasia Battery-Revised [23] and clinical
judgement of a qualified speech pathologist. Potential
people with aphasia and their family members will be
included if they are older than 18 years of age, have sufficient
English language to participate without a translator,
and have adequate hearing and vision levels to
participate as judged by the treating speech pathologist.
People with aphasia and their family member(s) will be
excluded if they have concomitant progressive neurological
conditions (for example, dementia) or a concurrent
medical condition impacting on their mental health
(for example, cancer) as confirmed by self-report. There
are no other inclusion or exclusion criteria for family
member participants. People with aphasia must present
with their first incidence of post stroke aphasia and will
be excluded for the following reasons: 1) aphasia as an
etiology other than stroke, 2) a history of recurrent
depression (that is, three or more previous diagnosed
episodes defined as needing to see a health practitioner
for treatment - either psychotherapy or medication prescribed,
confirmed by self-report), 3) a current psychiatric
diagnosis (for example, depressive disorder or anxiety
disorder confirmed by medical record), 4) current depressive
symptoms upon screening with the Stroke Aphasic
Depression Questionnaire Hospital Version-10 [17] (score
of 9 or more) or The Depression Intensity Scale Circles
[24] (score of 3 or more), 5) receiving treatment in a
psychiatric setting, or 6) enrolled in other aphasia or
depression treatment studies.
Process of screening and seeking consent
Potential participants with aphasia will be identified by a
member of the rehabilitation team. Speech pathologists
involved in the study will check the potential participant
for eligibility based on the inclusion/exclusion criteria.
Each potential participant with aphasia will be provided
with a written participant information sheet and consent
form and will be given a verbal explanation of the research.
The participant’s capacity to decide whether to
participate will be judged by the speech pathologist
(trained in communicating with and verifying comprehension
of adults with aphasia). Once participants with
aphasia have given consent, they will be asked if they
would like a family member to be involved in the study
and to nominate this family member. If the family member
agrees, the speech pathologist will verbally explain
the study as well as provide family members with a
participant information sheet and obtain their written
informed consent.
Randomization
A factor that may affect the outcome of this study is the
level of psychological services provided to patients in
each cluster. A National Stroke Foundation Rehabilitation
Services Report (2012) indicated that lower levels of
Worrall et al. Trials (2016) 17:153 Page 3 of 7
psychological care might be provided to patients with
stroke in nonurban areas in Australia. Hence, clusters
will be selected in a way such that they represent either
urban (capital city) or nonurban (regional/rural) areas.
Considering a cluster size of 20, the required sample size
of N = 344 (see sample size estimates for details) can be
achieved from 18 clusters (nine per arm, with five in
urban and four in nonurban clusters). However, 20 clusters
will be recruited to account for the potential of
cluster attrition during the study. See Table 1 for how
the 20 clusters will be stratified. Randomization will
occur using a computer-generated random number
scheme. Sequential numbers will be assigned to each
cluster within each stratum, and only the cluster numbers
will be sent to the trial statistician to ensure allocation
concealment.
Intervention details
Characteristics of both the experimental and attention
control interventions are summarized in Table 2. The
attention control arm of the study (SSPIP) will be provided
in a similar dosage and format to the experimental
intervention. The SSPIP condition will control for the
attention and time provided by speech pathologists to
participants [25]. The provision of secondary stroke prevention
information has had no known demonstrated
effect on the primary outcomes in this study. All study
treatments provided to participants will be documented
(that is, number of sessions of the intervention completed
and duration of each session). Both interventions
will be provided in addition to usual care. Documentation
of usual care will occur during the treatment period
and include, at a minimum 1) the hours and type of
speech-language pathology aphasia services received, 2)
the hours of counselling provided by health professionals
(for example, social worker or psychologist), and 3)
stroke- or aphasia-related support group attendance.
Primary outcomes
The two primary outcomes for people with aphasia will
be mood as measured by the Stroke Aphasic Depression
Questionnaire- 21 item (SADQ-21) [15] and quality of
life as measured by the Assessment for Living with
Aphasia (ALA) [16].
Secondary outcomes
The secondary outcome for people with aphasia will
include a 10-item measure of self-reported stroke riskrelated
behaviors [19]. Both ideal (for example, taking
medication as prescribed) and nonideal behaviors (for
example, smoking cigarettes) will be measured with
higher scores out of 10 indicating performance of more
ideal behaviors. Secondary outcomes for family members
of people with aphasia will be the impact of caregiving
measured by the Bakas Caregiving Outcomes Scale
Revised (BCOS) [17] and mental health as measured by
the General Health Questionnaire-28 item (GHQ) [18].
Blinding
People with aphasia, their family members, and outcome
assessors will be blinded to the study design and treatment
allocation (that is, will not know there are two
arms to the study). The speech-language pathologist
who completes the outcome assessment will be different
from the treating therapists. Unblinding of the outcome
assessors will not result in the discontinuation of a
participant’s involvement in the study. Attempts will be
made to replace the outcome assessor if unblinding
occurs and re-administration of any unblinded assessments
will occur.
Data management and monitoring body
Data will be collected and managed using REDCap, an
Internet-based data capture tool designed for research
studies. Clinicians from each hospital site will enter participant
data directly into REDCap. Once data collection
has commenced, data will be monitored for completeness
and accuracy by the study’s trial manager. The
study’s chief investigators will monitor study progress
and adverse safety events as well as audit data accuracy
on an ongoing basis. No formal criteria exist for discontinuing
the trial early.
Sample size estimates
Sample size calculations were calculated for both primary
outcome measures (ALA and SADQ-21). Power
calculations on the ALA have been calculated from an
intensive aphasia treatment study [26] and an Australian
longitudinal aphasia study [27]. Power calculations on
the SADQ have been calculated from the Cost analysis
of the Communication and Low Mood (CALM) study
[28]. The ALA required a larger sample size compared
to the SADQ-21, and therefore, the larger sample size
required by the ALA was determined necessary to adequately
power the study. To achieve a power of 80 %
with a 5 % level of significance in comparing the two
arms of the study (Aphasia ASK versus attention control
- SSPIP), we need 186 patients (93 per arm) with an effect
size of 0.367, computed using ALA data (26, 27).
Table 1 Stratification of clusters
Experimental
intervention
Attention control
intervention
Urban clusters (n = 10) five clusters five clusters
Nonurban clusters (n = 10) five clusters five clusters
Worrall et al. Trials (2016) 17:153 Page 4 of 7
The extent to which power is diminished by clustering
was considered in relation to the design effect (DE) =
1 + (m -1)r10, where m = the average size of a cluster
and r is the intra-class correlation coefficient. Typically,
intraclass correlation coefficients are small
(<0.02); thus a conservatively estimated intra-class
correlation of 0.02 was used. A cluster size of 20 was
chosen based on the feasibility of running the intervention,
as well as the availability of patients with
aphasia within clusters. Thus DE = 1+ (20-1)*0.02 =
1.38, and the total sample size required was calculated
as 186 * 1.38 ≈ 258. To account for an attrition rate of
25 % to the 12-month follow-up period, 344 patients
would be needed (172 per arm).
Statistical analyses
Baseline characteristics of participating patients of the two
arms will be presented and compared for any meaningful
differences at baseline. Outcomes of interest will be analyzed
on an intention-to-treat basis. Multilevel modelling
using mixed models, which takes into account patients being
nested within clusters, will be able to examine whether
changes in the outcomes, which are on interval-scale, vary
over time as well as across the two (Aphasia ASK and
attention control- SSPIP) programs, after adjusting for the
effects of any potential confounders (if any). In addition,
attrition patterns across the two arms will be examined to
determine randomness of missing data, and if required,
multiple imputations will be implemented. All statistical
analyses will be performed using Stata statistical software.
An alpha level of 0.05 will be accepted as significant. The
results of the statistical models will be presented in the
form of regression coefficients, their 95 % confidence
intervals, and effect sizes. The residuals of the fitted
models will be examined to ensure that all required assumptions
are met. The statistician completing the data
Table 2 Characteristics of the experimental and the attention control interventions
ARM 1: Experimental intervention ARM 2: Attention control intervention
Aphasia Action Success Knowledge (Aphasia ASK) Secondary Stroke Prevention Information Program (SSPIP)
Participants People with aphasia and their family members
Timing of
intervention
Participants will commence the intervention at any time before 6 months post stroke. Intervention will commence
within 14 days of baseline assessments and will be completed at 12 months post stroke.
Intervention delivery
mode
Intervention modules delivered face to face in 1:1 sessions.
Follow-up sessions conducted over the telephone.
Duration of
intervention
Face-to-face intervention: 6 weeks of intervention modules delivered 1 module/week for 1 to 2 hours (minimum
dosage = 3 modules completed and total contact time of 3 hours).
Follow-up phone intervention: up to 9 months of follow-up phone calls (of ½ to 1 hour duration) delivered monthly
until 12 months post stroke (minimum dosage = 4 phone calls completed and total time of 2 hours).
Intervention provider Qualified speech-language pathologist trained by the research team in either ARM 1 or ARM 2 interventions.
Intervention provider
training
Therapy manuals provided to therapists, mandatory completion of literature readings, and mandatory completion of
either face-to-face or online workshop for approximately 6 hours. If online training occurs it will be recorded and accessed via
Adobe Connect software.
Setting of
intervention delivery
The intervention will be provided on site at the health service where the participant is receiving rehabilitation or,
if the patient has been discharged from rehabilitation services, in the participant’s home.
Intervention process Therapists will guide participants through the modules, setting goals, discussing content and answering participant
questions and/or concerns. Tailoring of the content will occur in that participants will select the modules they
would like to complete and in which order. Tailoring will also occur for differing levels of aphasia severity to ensure
the intervention is communicatively accessible (for example, using conversational support strategies and seeing
people with more severe aphasia in person rather than conducting the session over telephone for the follow-up).
Intervention content six modules covering the following themes: six modules covering the following themes:
• aphasia and stroke education • stroke education
• basic communication strategies • risk factor education
• strategies for managing mood • lifestyle modifications for managing stroke risk factors
• strategies for maintaining social network support • medications for stroke prevention
Intervention materials Written support materials for each module with modifications made to formatting (for example, larger fonts and bolding of
key words) in order to improve accessibility of information for people with aphasia. Additional video materials will be made
available for some modules. Materials will be made available after the completion of the trial.
Fidelity of treatment All treatment sessions will be video recorded. The first module completed for all participants will be submitted to
research team for evaluation of patient interaction skills and content delivered. If deviation of fidelity is observed
retraining of the therapist will occur before administration of the intervention continues. Following all first session
evaluations, a random sample of videos will be selected to check fidelity is maintained throughout the study.
Worrall et al. Trials (2016) 17:153 Page 5 of 7
analyses will be blinded to group allocation until analysis
is completed.
Additional data collection and analyses
Qualitative interviews and/or survey data will also be
collected from participants and treating speech pathologists
upon completion of the 12-month evaluation and/
or the end of the study. The interviews and/or survey
data will gather information about the treatment services
that have been provided.
Discussion
This is the first known intervention tailored for people
with aphasia that aims to prevent depression and improve
longer-term outcomes by providing intervention early after
stroke. The intervention is of reasonably low intensity, and
if effective and integrated into speech pathology clinical
practice, it has the potential to not only improve mood and
quality of life but also other functional outcomes impacted
by mood.
Trial status
The target number of 20 clusters has been recruited, of
which 14 have had the relevant governance application approved
to start the trial. Clusters that have been approved
include the Darling Downs Service District, QLD; Wide
Bay Hospital and Health Service, QLD; Mackay Hospital
and Health Service, QLD; Western New South Wales
Local Health District, NSW; Northern Sydney Local
Health District, NSW; Sacred Heart Rehabilitation Service,
NSW; Hunter New England Local Health District, NSW;
Western Health, VIC; Barwon Health, VIC; Northern
Health, VIC; Monash Health, VIC; Peninsula Health, VIC;
Tasmanian Health Service- South, TA; and The Canberra
Hospital and Health Services, ACT.
Abbreviations
ALA: Assessment for Living with Aphasia; Aphasia ASK: Aphasia Action
Success Knowledge; BCOS: Bakas Caregiving Outcomes Scale revised;
CONSORT: Consolidated Standards of Reporting Trials; GHQ: General Health
Questionnaire; SADQ-21: Stroke Aphasic Depression Questionnaire- 21 item;
SPIRIT: Standard Protocol Items, Recommendations for Interventional Trials;
SSPIP: Secondary Stroke Prevention Information Program; TIDieR: Template
for Intervention Description and Replication.
Competing interests
The authors declare they have no conflicts of interest.
Authors’ contributions
LW, KH, IK, NSM, AK, TH, EP, LT, and MR were responsible for the initial
design of the study and obtaining funding. BR refined the study design and
wrote the full study protocol in consultation with LW, KH, IK, NSM, AK, TH,
EP, LT, and MR. KH and BR drafted the first version of this manuscript. LW, IK,
NSM, AK, TH, EP, LT, and MR critically reviewed the manuscript for intellectual
content. All authors read and approved the final manuscript.
Acknowledgements
The development and phase 1 study of the Aphasia ASK program were
supported by an Australian National Stroke Foundation Small Project Grant.
The authors would like to thank Emma Thomas and Dr. Emma Finch
from The University of Queensland and Kathy Clark, Dr. Jennifer
Lethlean, Tania Quaglio, and Dr. Anna Farrell from Queensland Health
for their invaluable contribution to the development of the Aphasia ASK
intervention. Dr. Shirley Thomas, The University of Nottingham is also thanked
for advice on outcome measurement.
Author details
1
National Health and Medical Research Council Centre for Clinical Research
Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane,
Australia. 2
School of Health and Rehabilitation Sciences, The University of
Queensland, Brisbane, Australia. 3
Discipline of Clinical Psychology, University
of Technology, Sydney, Australia. 4
Southeastern Louisiana University,
Hammond, Louisiana, USA. 5
Centre for Research in Evidence-Based Practice,
Bond University, Gold Coast, Australia. 6
Speech Pathology, Faculty of Health
Sciences, The University of Sydney, Sydney, Australia. 7
School of Allied
Health, La Trobe University, Melbourne, Australia.
Received: 27 August 2015 Accepted: 25 February 2016
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Worrall et al. Trials (2016) 17:153 Page 7 of 7
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