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Trial registered on ANZCTR


Registration number
ACTRN12619000452190
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
19/03/2019
Date last updated
6/09/2019
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the effects of an integrative treatment for depression and / or anxiety in adults
Scientific title
Efficacy of an integrative treatment (Personalised Integrative Therapy) for depression and / or anxiety in adults: a randomised controlled pilot trial
Secondary ID [1] 297624 0
Nil known
Universal Trial Number (UTN)
U1111-1229-6037
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311907 0
Anxiety 311908 0
Condition category
Condition code
Mental Health 310489 310489 0 0
Depression
Mental Health 310490 310490 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313868 0
Treatment: Other
Intervention code [2] 313869 0
Lifestyle
Intervention code [3] 313870 0
Behaviour
Comparator / control treatment
Cognitive behaviour therapy (CBT). This involves education about the relationship between thoughts and feelings, and techniques to change unhelpful thoughts. Relaxation techniques will be covered and the importance of increasing daily activity. The CBT condition comprises attendance to a one-day workshop plus 6 weeks of goal-setting based on the topics covered in the workshop. Participants will also receive SMS messages and emails twice weekly reminding them to continue with their change efforts. Reminders about topics covered in the one-day workshop will also be sent.
Control group
Active

Outcomes
Primary outcome [1] 319354 0
Change in depressive symptoms as assessed by the Depression, Anxiety, and Stress Scale (DASS-21).
Timepoint [1] 319354 0
Weeks 3, 6, 9 and 12 (week 6 is primary endpoint)
Primary outcome [2] 319452 0
Change in anxiety symptoms as assessed by the Depression, Anxiety, and Stress Scale (DASS-21).
Timepoint [2] 319452 0
Weeks 3, 6, 9 and 12 (week 6 is primary endpoint)
Primary outcome [3] 319453 0
Change in stress symptoms as assessed by the Depression, Anxiety, and Stress Scale (DASS-21).
Timepoint [3] 319453 0
Weeks 3, 6, 9 and 12 (week 6 is primary endpoint)
Secondary outcome [1] 367862 0
Change in quality of life and general health as assessed by the Short Form-36 Health Survey (SF-36)
Timepoint [1] 367862 0
Weeks 3, 6, 9 and 12
Secondary outcome [2] 367863 0
Change in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 367863 0
Weeks 3, 6, 9 and 12
Secondary outcome [3] 367864 0
Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
Timepoint [3] 367864 0
Weeks 3, 6, 9 and 12
Secondary outcome [4] 367865 0
Change in diet quality as measured by the Mediterranean Diet Adherence (MDA) Questionnaire
Timepoint [4] 367865 0
Weeks 3, 6, 9 and 12
Secondary outcome [5] 367866 0
Change in negative thoughts as measured by the Perseverative Thinking Questionnaire (PTQ)
Timepoint [5] 367866 0
Weeks 3, 6, 9 and 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be allocated a participant number (1 to 60) based on the order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 60 into either group 1, 2, or 3. Participants will be unaware of treatment allocation until their attendance to the one day, in-person workshop. Details of the content of alternative treatments modalities will not be discussed with participants throughout the study.

Allocation concealment will occur via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study examining the initial efficacy and acceptability of an integrative treatment for depression and anxiety. As a result, a convenience sample size of 60 selected

Pre and post analyses will be conducted to determine changes in the following:
1. Depression, Anxiety and Stress Scale (DASS-21)
2. Mediterranean Diet Adherence (MDA)
3. Short Form-36 Health Survey (SF-36).
4. Pittsburgh Sleep Quality Index (PSQI)
5. Perseverative Thinking Questionnaire (PTQ)
6. International Physical Activity Questionnaire (IPAQ)

Comparisons will be made between the three conditions to determine if changes in symptoms are significantly different.

These analyses will be conducted via a repeated measures analysis of variance via SPSS

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2019
Actual
24/05/2019
Date of last participant enrolment
Anticipated
13/05/2019
Actual
1/06/2019
Date of last data collection
Anticipated
26/08/2019
Actual
30/08/2019
Sample size
Target
60
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302166 0
Commercial sector/Industry
Name [1] 302166 0
Metagenics Australia
Country [1] 302166 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 302006 0
Commercial sector/Industry
Name [1] 302006 0
Clinical Research Australia
Address [1] 302006 0
38 Arnisdale Rd Duncraig WA 6023
Country [1] 302006 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302847 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 302847 0
90 South St Murdoch WA 6150
Ethics committee country [1] 302847 0
Australia
Date submitted for ethics approval [1] 302847 0
16/01/2019
Approval date [1] 302847 0
19/02/2019
Ethics approval number [1] 302847 0
2019/003

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91594 0
Prof Peter Drummond
Address 91594 0
Murdoch University
College of Science, Health, Engineering and Education (SHEE)
90 South St Murdoch WA 6150
Country 91594 0
Australia
Phone 91594 0
+61 8 9360 2415
Fax 91594 0
Email 91594 0
[email protected]
Contact person for public queries
Name 91595 0
Adrian Lopresti
Address 91595 0
Clinical Research Australia
38 Arnisdale Road
Duncraig WA 6023
Country 91595 0
Australia
Phone 91595 0
+61 8 94487376
Fax 91595 0
Email 91595 0
[email protected]
Contact person for scientific queries
Name 91596 0
Adrian Lopresti
Address 91596 0
Clinical Research Australia
38 Arnisdale Road
Duncraig WA 6023
Country 91596 0
Australia
Phone 91596 0
+61 8 94487376
Fax 91596 0
Email 91596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator. Requests to be emailed to Dr Adrian Lopresti [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Feasibility and Efficacy of a Brief Integrative Treatment for Adults With Depression and/or Anxiety: A Randomized Controlled Trial.2020https://dx.doi.org/10.1177/2515690X20937997
N.B. These documents automatically identified may not have been verified by the study sponsor.