An examination into the effects of an integrative treatment for depression and / or anxiety in adults

Not Applicable

Completed

• Conditions: Depression; Anxiety; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12619000452190
• Lead Sponsor: Murdoch University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2019-08-30
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>];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 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 Measures

Name	Time	Method
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];Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ)[Weeks 3, 6, 9 and 12];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]