None listed
Conditions
Brief summary
In this randomised controlled pilot trial, we will evaluate the efficacy of an integrative treatment (Personalised Integrative Therapy/ PI Therapy) for mild-to-moderate depression and/or anxiety in adults. 60 participants will be randomly allocated into one of three conditions: (1) PI Therapy (PIT), (2) PI Therapy plus supplements (PIT+S), or (3) Cognitive-behaviour therapy (CBT). All participants will attend a one-day workshop (PIT, PIT+S or CBT) and will then receive 6-weeks of SMS or email support. In the one-day CBT workshop, principles, techniques, and exercises based on a CBT framework will be presented. In the PI Therapy workshops, areas targeted cover the domains of diet/nutrition, psychology/coping skills, lifestyle/environment, social/spiritual, and medical/physical. PIT+S will also include a discussion on the potential benefits of several natural supplements which will then be provided to participants in this group. Over the following 6 weeks participants will set weekly goals to enhance their CBT skills (CBT group) or skills/areas of change covered in PI Therapy. We will assess changes in mood, quality of life, negative thinking patterns, diet, sleep, supplementation, and physical activity over time. We will also examine if the treatment conditions have differing effects in these areas. Finally, we will assess if changes in these areas (i.e., diet, physical activity, sleep, supplements, negative thinking patterns) are associated with changes in mood over time.
Interventions
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 consis
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 morning) Participants in Condition 3 will be asked to complete a supplement monitoring form every week where they will indicate the frequency and ease associated with taking their supplements. Following the one-day workshop, all participants will receive emails and SMS reminders twice weekly reminding them to continue with their change efforts. Reminders about topics covered in the one-day workshop will also be sent. Participants in all conditions will receive the same number of emails and SMS messages. Every week, participants will be asked to complete a weekly rating sheet indicating their level of effort and success at practising/implementing a skill or exercise covered in their respective one-day workshop. The workshops will be delivered by clinical psychologists with specialist training in the integrative approach. Participants will be followed up 3 (week 9) and 6 weeks (week 12) after treatment completion to evaluate maintenance of treatment gains.
Sponsors
Murdoch University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Exclusion criteria
1. DSM-5 diagnosis including but not limited to bipolar disorder, schizophrenia, psycho-organic syndromes, eating disorders, substance abuse or dependence disorders. 2. At significant risk of suicide or engaging in self-harm behaviours. 3. Suffering from major medical illness impacting on ability to implement many lifestyle, dietary, and psychological changes covered in the program. Medical disorders include but are not limited to cancers, serious cardiovascular disease, neurodegenerative disorders (e.g., Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease), and unmanaged metabolic disorders such as diabetes. 4. Currently receiving psychological therapy for depression or anxiety by a mental health practitioner 5. Currently taking greater than 2 natural supplements that are included in the PI + supplements condition 6. Known allergy or significant intolerance to natural supplements
Outcome results
None listed