None listed
Conditions
Brief summary
Depression is common following stroke, affecting one in three stroke survivors (Hackett et al., 2009), and it is considered one of the strongest predictors of reduced quality of life (Kim et al., 1999; King, 1996). Studies investigating treatments for post-stroke depression have mainly examined pharmacological treatments (Hackett et al., 2009), and only a small number of studies have examined psychological treatments. In a series of case studies, Rasquin et al. (2009) found that four of five stroke patients who completed cognitive-behavioural therapy (CBT) reported reduced depressive symptoms. Aphasia refers to a communication impairment caused by damage to the language centres of the brain and can include difficulties with expressive language (e.g., speaking/writing), receptive language (i.e., comprehension of what is said or what is read) or both. Stroke survivors with aphasia are at a further increased risk of experiencing depression (De Ryck et al., 2013; Hilari, 2011; Kauhanen et al., 2000). Furthermore, it is unclear whether CBT, which is predominantly a talking-based psychological therapy, can be successfully modified and tailored for feasible and effective delivery to stroke patients with depression and aphasia. In consideration of this evidence, this study aims to investigate the feasibility and efficacy of a CBT intervention in reducing depressive symptoms in individuals with aphasia secondary to stroke. A series of nine case studies will be conducted to evaluate the efficacy of a modified and individually tailored CBT program. This study will help inform future research and clinical practice, and will contribute to best practice standards in stroke rehabilitation and care.
Interventions
Baseline (Phase A)
Following consent procedures, baseline data collection will be completed using the measures below, twice weekly for a number of weeks (randomised to either 2.5, 4.5, or 6.5 weeks – following a randomised multiple baseline design). Initially data will be collected in person to ensure data integrity. However, telephone, mail out and computer-based prompting to complete measures will be considered, dependent on participant ability. The measures collected are listed below.
• Demo
Baseline (Phase A) Following consent procedures, baseline data collection will be completed using the measures below, twice weekly for a number of weeks (randomised to either 2.5, 4.5, or 6.5 weeks – following a randomised multiple baseline design). Initially data will be collected in person to ensure data integrity. However, telephone, mail out and computer-based prompting to complete measures will be considered, dependent on participant ability. The measures collected are listed below. • Demographic and Medical Information – Data and Contact Sheet (patient, close other or hospital with consent) – initial contact only • Depression Intensity Scale Circles (DISCs) – twice weekly • Stroke Aphasic Depression Questionnaire-Community 10 (SADQ-C10; close other) – twice weekly • Subjective Units of Distress Measure – Depressive Symptoms Adapted for Aphasia (SUDS-DA; patient) – twice weekly • Subjective Units of Distress Measure – Anxiety Symptoms Adapted for Aphasia (SUDS-AA; patient) – twice weekly • Western Aphasia Battery (WAB-R; patient) – initial contact only • Behavioural Outcomes of Anxiety (BOA; close other) – twice weekly • Assessment for Living with Aphasia (ALA; patient) – initial contact only • Aphasia-friendly EQ5D (CPI-3L, UKPI-3L, or UKPI-5L; patient) – initial contact and at the end of follow up Intervention (Phase B: 10 sessions over 4 months) Participants will begin their intervention of cognitive behavioural therapy tailored to the cognitive consequences of stroke and using supported communication techniques, in line with the Tailored Cognitive Behavioural Therapy for Aphasia (TCBTA) protocol. All therapy sessions will be delivered by a clinical neuropsychologist with more than eighteen years’ experience and with extensive experience in conducting tailored psychological interventions with stroke survivors. They will be conducted at the Thinking Matters’ clinic in Elwood, or via video-conferencing platform. It is anticipated that most participants will complete therapy in approximately 10 sessions; however, some variability is expected. Sessions will begin weekly, progressing to fortnightly (e.g., 6 weekly sessions followed by 4 fortnightly sessions), with homework undertaken between sessions. During this intervention phase, data collection will continue as per the baseline phase. That is, twice-weekly completion of the following measures: DISCs (patient), SADQ-10C (close other), SUDS-DA (patient), SUDS-AA (patient), BOA (close other). Following completion of the therapy, the participant will be invited to complete a semi-structured interview which will explore their qualitative experience of the therapy. Following completion of therapy, a 4-week follow up (Phase A) will commence. At the end of the follow-up phase, the patient will again complete the aphasia-friendly EQ5D. Subsequently, two booster sessions will be provided over four weeks (Phase C). Following completion of the booster sessions, a second 4-week follow up (Phase A) will commence. As per all previous phases, the DISCs, SADQ-10C, SUDS-DA, SUDS-AA and BOA will be completed twice weekly. Therapy sessions will be audio recorded for the purpose of ensuring quality of the treatment. In order to ensure fidelity to the protocol, some participants may need to be video-recorded, as the nature of aphasia communication may involve a lot of non-verbals. The CBT programme follows a manualised treatment regimen. To measure the quality of this intervention, and standardise its delivery, sessions will be recorded and reviewed at a later date. This is to ensure that the delivery of the clinical intervention is consistent with the regimen prescribed in the manual. Specifically, this analysis is called: Therapist Treatment Adherence Analysis. A second researcher on this study (i.e., not the clinical neuropsychologist delivering the intervention) will review 20% of the recorded sessions and compare the content to the treatment manual. Adherence of 80% or more will be considered adequate.
Sponsors
A/Prof Rene Stolwyk
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recent ischaemic or haemorrhagic stroke; clinical diagnosis of aphasia (either receptive, expressive or both) from a speech pathologist using the Western Aphasia Battery (WAB-R); self-reported (score of 2 or more on the Depression Intensity Scale Circles (DISCs)) low mood; capacity to consent (with assistance) to research participation; and capacity and availability to engage in a multi-session therapeutic program with a private clinical neuropsychologist.
Exclusion criteria
1. Individuals under the age of 18 years are not eligible to participate in the project as we are interested in the efficacy of this intervention in the adult population. 2. Individuals with a previous or concurrent major neurological (e.g. head injury, dementia) or psychiatric (e.g. schizophrenia, bipolar disorder) history will be excluded as these variables will likely confound the results and limit the conclusions that can be drawn from the study. Individuals with a long psychiatric history or progressive neurological conditions will likely experience a different treatment effect; therefore, it will be difficult to draw conclusions about the intervention if these individuals are included. 3. Individuals who are not able to engage and do not have access to transport to attend a multi-session (approximately 10 sessions) therapeutic program with a private clinical neuropsychologist. The clinic is centre-based and there is no funding for home based interventions; therefore, the individual would need to be able to arrange their own transport to the clinic.
Outcome results
None listed