None listed
Conditions
Brief summary
Depressive symptoms are common and undermine the quality of life of people with Alzheimer’s disease (AD). Cholinesterase inhibitors and antidepressants have all but no effect on the mood of patients, and their use is associated with greater risk of adverse events compared with placebo. The use of traditional psychotherapeutic interventions, such as cognitive behavioural therapy, is hindered by the presence of cognitive impairment. Cognitive bias modification (CBM) is a novel, simple and safe intervention that targets attentional and interpretative biases associated with anxiety, dysphoria and depression. CBM operates through implicit learning systems, which are spared until late in the course of the dementia illness. CBM is effective at reducing depressive symptoms in adults without cognitive impairment and our pilot data indicate that this is a feasible and, most likely, efficacious treatment for people with depression in AD (DAD). Moreover, CBM is safe and unlikely to be associated with significant adverse events in this vulnerable population. RAPID will evaluate this innovative intervention in a carefully designed trial that brings together an accomplished team of investigators with expertise in ageing research, depression, dementia, CBM, randomised trials and translation of research findings into clinical practice. This study will produce definitive high quality evidence for the benefits of CBM in improving the quality of life of people with DAD.
Interventions
Participants will be asked to attend the WA Centre for Health and Ageing, Royal Perth Hospital, on a daily basis for a total of 10 sessions of cognitive bias modification (CBM) (2 weeks – excluding weekends). Each session will be delivered on a 24’’ high-resolution screen using a local PC station, and will last approximately 30 minutes: 15 minutes each for CBM-Attention (CBM-A) and for CBM-Interpretation (CBM-I).
In the CBM-A session, participants will be shown pairs of emotionally discrepant
Participants will be asked to attend the WA Centre for Health and Ageing, Royal Perth Hospital, on a daily basis for a total of 10 sessions of cognitive bias modification (CBM) (2 weeks – excluding weekends). Each session will be delivered on a 24’’ high-resolution screen using a local PC station, and will last approximately 30 minutes: 15 minutes each for CBM-Attention (CBM-A) and for CBM-Interpretation (CBM-I). In the CBM-A session, participants will be shown pairs of emotionally discrepant photos for 500 ms (sad or neutral/happy faces). Each pair will then be replaced by a small probe (square or circle) appearing in the screen position previously occupied by one of the photos. Participants will be instructed to use a response box with a square and a round button to indicate the shape of the probe that appeared on the screen. The probe will then disappear and will be replaced, after 1 second, by another pair of photos to initiate the next trial. The time to discriminate probe identity (square or circle) will be recorded automatically. In the active CBM condition, designed to reduce attention to negative information, probes will always appear in the position of neutral/happy faces. In the interpretative CBM sessions (CBM-I), single ambiguous cue-words that permit a negative and benign interpretation (e.g., BEAT) will first appear in the top half of the screen for 1s. Then two words will appear on the bottom half of the screen: one on the left and the other on the right hand side. This word-pair will consist of one target word that is semantically related either to the negative or benign meaning of the ambiguous cue-word (e.g., VICTORY or PUNISH), and one word that is unrelated to either meaning of the ambiguous cue-word (e.g., CLOUD). Participants will be asked to identify which is the target word and use the response box to indicate whether the semantically-related word appeared on the left or right-hand side of the screen (by pressing the left or the right hand side button on the response box, respectively). The time required to accurately identify the target word will be recorded automatically. In the active CBM condition, designed to reduce negative interpretations of ambiguity, target words always will be associated with the benign meanings of the cue-words, discouraging their negative interpretation.
Sponsors
WA Centre for Health & Ageing
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
We will recruit 80 people with depression in mild to moderate severity Alzheimer’s disease according to the following inclusion criteria: 1. Diagnosis of probable AD according to NINCDS-ADRDA criteria, which is largely consistent with DSM-V diagnosis of major neurocognitive disorder due to probable AD, 2. Mini-Mental State Examination (MMSE) score equal or greater than 15, 3. Cornell Scale for Depression in Dementia (CSDD) equal or greater than 8, 4. Fluent in written and spoken English (preferred language for at least 10 years).
Exclusion criteria
We will exclude from participation people who have: 1. One or more diseases likely to compromise ongoing participation in the trial (for example, severe visual impairment), 2. A weekly alcohol consumption greater than 28 standard drinks (> 4 drinks per day) or 6 or more standard drinks on any one day of the week, 3. Active suicidal intent, 4. No health practitioner who is able to provide ongoing clinical care, 5. Changed antidepressants during the preceding four weeks, 6. Not given informed consent to participate.
Outcome results
None listed