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Web-based Cognitive Behavioural Therapy for Women with Postnatal Depression
Every year, Postnatal Depression (PND) affects at least 40,000 women in Australia. It has serious consequences for maternal mental health and infant development. Poor uptake of clinic-based treatments suggests a Web-based treatment can play a major role in tackling this public health problem, particularly as an increasing number of women will be identified as depressed through the National Perinatal Depression Initiative. Major barriers to treatment include stigma; poor access; treatment costs, and scheduling trips outside of the home with a new baby. We have developed an interactive, Web-based treatment targeted to women with PND and now aim to evaluate its efficacy comapred to Standard Care in a 2-group randomised controlled trial. The main aims are to: (a) pilot the efficacy of the program with respect to the primary outcomes of depressive episode remission, and amelioration of depression and anxiety symptoms; and (b) to pilot the efficacy of the MumMoodBooster program with respect to secondary outcomes including the putative CBT change mechanisms, perceived stress, and marital functioning. A total of 50 mothers will be recruited via our well-developed relationship with Maternal and Child Health Centres in Victoria. In addition, the study will be advertised widely, targeting rural women (i.e. Internet e.g. beyondblue, local newspapers, magazines), and appropriate health professionals/services (e.g., GPs, PaNDA, etc) will be contacted and encouraged to screen and/or refer women with suspected PND. Rural is defined as: women in regional, rural, and remote areas outside the CBD (more than 50kms). Women in these areas generally have poorer access to a variety of mental health services. Potential recruits will be screened with the Edinburgh Postnatal Depression Scale (EPDS) and those scoring 13-20, inclusive, on the EPDS will be considered for further involvement. Following referral, women will be contacted by a member of the research team to assess eligibility and explain the study. Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV (SCID). Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy). Following contact with women via phone, a Participant Information and Consent Form will be sent in the mail and potential participants will be asked to sign it and return it to the researchers. A clinical assessment will be completed by phone and participants will be asked to complete the questionnaires by visiting the secure website. Women will be randomised in a 1:1 ratio to Web-based CBT with telephone support (n = 25), or to treatment as usual (n = 25), using a pre-generated permuted blocks allocation schedule. Post-test data will be collected at 9 weeks post-enrolment and follow-up data at three months post-enrolment.
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Youth Depression Alleviation: Augmentation with Anti-inflammatory Agent (YoDA-A)
This study is 12-week acute treatment trial for moderate to severe major depressive disorder (MDD). It is designed to establish whether the use of (i) rosuvastatin or (ii) aspirin, reduces symptom severity and prevents recurrence of depression in young people. In this 3-arm controlled design, add-on therapy to treatment as usual (TAU) with rosuvastatin or aspirin will be compared to placebo. Aims Using a randomised placebo controlled trial, we aim to assess in individuals presenting to specialised early intervention centres with moderate to severe major depression if: 1. 12 weeks treatment with either 10 mg rosuvastatin or 100 mg aspirin treatment reduces severity of depression compared to individuals taking treatment as usual: Primary aim. 2. 12 weeks with either 10 mg rosuvastatin or 100 mg aspirin treatment will improve self-reported symptom burden, quality of life, overall functioning and clinical impression and reduce symptoms of anxiety. 3. There are continued benefits following cessation of trial treatment assessed at 6 months following baseline. 4. whether 12-weeks treatment with 10 mg rosuvastatin or 100 mg aspirin reduces serum markers of inflammation, and 5. whether the reduction in inflammatory and oxidative markers correlates with change in depressive symptomatology Primary Hypothesis 1. 12-weeks of adjunctive rosuvastatin or aspirin treatment will be superior to placebo for reducing symptoms of depression using the Montgomery-Asberg Depression Rating Scale (MADRS). Analysis of rosuvastatin compared with placebo will be conducted separately to aspirin compared with placebo. Changes in MADRS scores in each medication individually are the primary outcomes. Predictors of outcome The study will also aim to explore predictors and moderators of treatment response. Predictors are variables present before treatment that influence a person's response to treatment, regardless of the type of treatment received; whereas moderators differentially predict response to the different treatments. We will explore questions such as whether young people with comorbid substance abuse and borderline personality disorder traits are less likely to respond to treatment overall and less likely to respond to one treatment compared to the other. We will also examine whether baseline cognitive factors predict response to the trial medication.
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Colomid: Midkine as a predictive marker in colorectal cancer
This study is recruiting participants with advanced or metastatic colorectal cancer, who are going to start on a new course of chemotherapy. It will investigate a new blood test, called Midkine, and determine if it is better than the standard tests (CEA and CT scans), at identifying whether or not the chemotherapy is effective. Who is it for? You may be eligible to join this study if you are 18 years or over, have been diagnosed with metastatic or locally advanced colorectal cancer and due to starting on a new course of chemotherapy. Full inclusion criteria for this study can be found in the appropriate section of this form. Trial details In this study, you will be observed for a total period of 6 months, or until your cancer progresses. You will have standard and midkine blood tests before starting chemotherapy, a midkine sample taken at 2 weeks and then standard and midkine blood tests every 3-4 weeks, whilst receiving chemotherapy for your colorectal cancer. The interval between blood tests depends on when blood tests are required for the chemotherapy regimen that is being used. The only extra blood test you will require is for midkine at 2 weeks after starting on the study.
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Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy (SBRT) using audiovisual (AV) biofeedback
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Standard upper limb therapy treatment with or without non-invasive brain stimulation to assist recovery after stroke
A stroke occurs when the blood flow to the brain is suddenly stopped which causes brain cells in the area to die (infarct) because they are no longer receiving the oxygen and nutrients that they need to function. A stroke can have a devastating effect on the person because the brain controls the way we move, think, speak, and perform different tasks. It is very important to treat people after a stroke as soon as possible so that they are able to recover movement in the affected body parts and look after themselves without having to be dependent on others. Normally movement of the arm and leg is controlled by the opposite side of the brain. After stroke, the unaffected side of the brain may exert a dampening effect on the stroke affected side, preventing it from being active and controlling the opposite side of the body. This study aims to (1) Look at how easy it will be, over a 9 month period, to recruit 40 people presenting to SCGH who have had a particular type of stroke and as a result are unable to use their hand/arm; (2) record techniques used by physiotherapists and occupational therapists to help these people to use their affected arm after stroke; (3) study the effects of a safe low current electrical stimulation (transcranial direct current stimulation - tDCS) to the healthy side of the brain to reduce its dampening down effect on activity in the stroke affected brain. Stimulation, via electrodes placed on the scalp, will be applied at the same time as the affected arm is being treated. This study will recruit patients within 1 week after their stroke. They will be randomly split into two groups: group 1 will receive treatment to their arm plus tDCS to the healthy side of the brain and group 2 will receive treatment to their arm plus ‘pretend electrical stimulation’ (sham tDCS) to the brain.
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Brief telephone interventions for reducing future alcohol use and related harm in young people accessing emergency departments
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A Phase 2 Study of patients treated for relapsed Follicular Lymphoma: with Revlimid (Registered Trademark) consolidation added to Rituximab maintenance therapy in those remaining Positron Emission Tomography (PET) positive (ALLG NHL26)
The prognosis for patients with FL has significantly improved during the last decade with the incorporation of Rituximab into therapy. Rituximab maintenance has become a standard of care after initial rituximab-chemotherapy for remission induction. Lenalidomide is an immune system modulating drug that has anti-lymphoma properties demonstrated in smaller studies of patients with relapsed/refractory Diffuse large B-cell lymphoma. Lenalidomide consolidation added to Rituximab maintenance therapy may convert PET+ patients to PET-, without causing unmanageable side effects. Positron emission tomography (PET) is a medical imaging tool that can detect cancer in its early stages, help to monitor cancer treatment and check if the cancer is coming back. Lay Summary: Follicular lymphoma is the most common type of slow growing non Hodgkin lymphoma. Treatments and outcomes have improved considerably in the last 10 years with the introduction of the drug, rituximab to standard chemotherapy treatments. However, the disease returns repeatedly in many patients. PET scanning is a type of test used by doctors to outline where the lymphoma is in the body. PET scans will ‘light up’ the areas of active follicular lymphoma. Such positive PET scans after the end of treatment indicate that it is likely the lymphoma will return soon. This study is for patients with returned disease who have already received treatment again and so are at even higher risk of disease returning yet again. Patients will receive rituximab and up to 24 months of another drug, lenalidomide, which is designed to help the body’s own immune system to keep the lymphoma away. The study will decide if the extra treatment with lenalidomide can change the scan result to negative and improve patient outcomes.
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A study to compare the effect of three burns dressings on burns in children
At the Royal Children's Hospital in Brisbane the standard of care in burns dressings for small to medium partial thickness burns has changed over the years. Currently, silver containing dressings are used to prevent infection and promote healing. However despite the large number of burns dressings available on the market, very few high level trials have been conducted in children or adults. This study aims to determine the effect of various silver and silicone containing burns dressings for the treatment of partial thickness burns in children. The study hypothesises that: 1. Rate of healing, need for grafting and subsequent scarring from a burn wound is partly determined by the choice of dressing used. 2. The choice of dressings used can partly assist with pain and anxiety strategies during dressing change procedures; and impacts on a child's comfort and engagement in activities. 3. The dressing which best fulfils the above qualities will also be the most cost effective.
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Pilot of a self-help app to support suicide prevention amongst Indigenous youth
This project aims to investigate whether a self-help interactive program delivered via tablet devices can help Indigenous youth to reduce their suicidal ideation. Participants will be randomly assigned to either the intervention group, which includes therapeutic activities grounded in acceptance and commitment therapy or a wait list control group. We predict those using the intervention program will report reduced suicidal ideation and mental distress after using the program for 6 weeks.
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Studying an online educational course for supporting emotional health of dialysis patients
This study is to evaluate the feasibility, effectiveness, and acceptability of an internet-delivered treatment program for depression and anxiety amongst dialysis patients using an open trial design (pilot study). The study also aims at modifying the content and materials to enhance the treatment acceptability and effectiveness by obtaining participants’ feedback and incorporating the evidence-based components specific to dialysis patients