Authors
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Murdoch University -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2019
INTERVENTION: Adult participants with a mild‐to‐moderate severity of depression and/or anxiety will be randomly allocated to one of 3 treatment conditions comprising: • Condition 1: Cognitive‐behaviour therapy (CBT) • Condition 2: An integrative treatment (Personalised Integrative Therapy) covering diet, psychology, exercise, sleep and other lifestyle factors, or • Condition 3: An integrative treatment (Personalised Integrative Therapy) plus nutraceutical supplementation All treatment conditions will consist of a one‐day face‐to‐face group workshop followed by 6‐weeks of weekly goal setting based on topics covered in the workshop. All participants will receive a workbook containing information covered in the one‐day workshop plus sections to set weekly goals for change and complete relevant exercises. The workshops will comprise didactic presentations, PowerPoint slides, and individual and small group exercises. These workshops will be held in an appropriately‐sized community venue located near the CBD. In the CBT condition (condition 1), participants will set weekly goals to enhance/learn skills/topics covered in the one‐day workshop. These consist of exercises to identify and change unhelpful thoughts, increase daily activity, and relaxation exercises. In the two integrative treatments (conditions 2 and 3), participants will set personalised goals for change in the areas of diet, sleep, exercise, physical activity, coping skills, and other lifestyle areas that are covered in the one‐day workshop. Participants will set their own goals for change based on the areas they feel are impacting on their mood and general wellbeing. In the integrative treatment plus supplements (condition 3) participants will receive a 12‐week supply of the following: 1. Fish oil (1 capsule twice daily) 2. Probiotic (1 capsule daily, taken morning or evening) 3. Curcumin/saffron tablets (1 tablet twice daily) 4. B‐complex (1 tablet daily, taken in the mor CONDITION: Depression;Anxiety; ; Depression ; Anxiety Mental Health ‐ Anxiety Mental Health ‐ Depression PRIMARY OUTCOME: Change in anxiety symptoms as assessed by the Depression, Anxiety, and Stress Scale (DASS‐21). [Weeks 3, 6, 9 and 12 (week 6 is primary endpoint)] Change in depressive symptoms as assessed by the Depression, Anxiety, and Stress Scale (DASS‐21). [Weeks 3, 6, 9 and 12 (week 6 is primary endpoint); ] Change in stress symptoms as assessed by the Depression, Anxiety, and Stress Scale (DASS‐21). [Weeks 3, 6, 9 and 12 (week 6 is primary endpoint)] SECONDARY OUTCOME: Change in diet quality as measured by the Mediterranean Diet Adherence (MDA) Questionnaire[Weeks 3, 6, 9 and 12] Change in negative thoughts as measured by the Perseverative Thinking Questionnaire (PTQ)[Weeks 3, 6, 9 and 12] Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ)[Weeks 3, 6, 9 and 12] Change in quality of life and general health as assessed by the Short Form‐36 Health Survey (SF‐36)[Weeks 3, 6, 9 and 12] Change in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)[Weeks 3, 6, 9 and 12] INCLUSION CRITERIA: 1. Adults (male and female) aged between 18 and 65 years 2. Self‐reported mild‐to‐moderate depression and/or anxiety as assessed by the DASS 3. Fluent in English 4. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial. 5. Willing and able to participate in this 12‐week study (6 active weeks plus 6‐week follow‐up) 6. If taking pharmaceutical medications (including antidepressants) must be on a stable dose for the last 8‐weeks. All participants should continue to take their pharmaceutical medications as prescribed by their treating doctor during the trial.
Epistemonikos ID: ecf5a5b96df78db237d608d9ac48e85aceb849f3
First added on: Aug 24, 2024