Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001079336
Ethics application status
Approved
Date submitted
13/07/2017
Date registered
25/07/2017
Date last updated
15/09/2020
Date data sharing statement initially provided
1/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Group Psychological Intervention for People with Depression and Overweight/Obesity
Scientific title
Group Psychological Intervention for People with Depression and Overweight/Obesity: effect on dietary changes, exercise levels and depressive symptoms.
Secondary ID [1] 292427 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
GPIPDO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 304023 0
depression 304024 0
Obesity 304030 0
Condition category
Condition code
Mental Health 303353 303353 0 0
Depression
Diet and Nutrition 303354 303354 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10 week group programme devised by mental health clinicians:
Taryn Lores - Psychologist - Course Facilitator - practicing Health psychologist
Kathryn Collins Psychologist - practicing clinical psychologist – Co-Director Psychology SA Health
Anne Burke Psychologist - practicing clinical psychologist - Co-Director Psychology SA Health
Dr Mike Musker - Senior Research Fellow and Registered Mental Health Nurse - Course Facilitator - 30 years experience in mental health nursing
Professor Julio Licinio - Psychiatrist - 30 years as a psychiatrist
The clinical team has developed a manual that will be facilitated by Dr Michael Musker and Taryn Lores, both experienced in providing group interventions.
The groups will be measured using standardised and validated clinical tools: These assessments will occur prior, at the end of the groups i.e) after week 10 of the group; at 3 months, and 1 year after the interventions.
Program Overview
Session 1 – Introducing the Program
Session 2 – Establishing a Foundation (Education)
Session 3 – Getting Moving (Behavioural Strategies I)
Session 4 – Building Awareness (Behavioural Strategies II)
Session 5 – Addressing Emotions (Stress Management)
Session 6 – Watching Your Thinking (Cognitive Strategies I)
Session 7 – Challenging Your Mind (Cognitive Strategies II)
Session 8 – Valuing Yourself (Self-Worth & Body Image)
Session 9 – Considering the Bigger Picture (Broader Health)
Session 10 – Planning for the Future (Relapse Prevention)

Program Aim
To assist people with depression to lose weight, improve their physical health and mental health

Specific goals:
• Improve relationship with body and mind
• Increase understanding of nutrition and healthy living
• Foster a more positive relationship with food and eating, and with exercise and activity
• Lose weight / move toward most healthy, comfortable weight
• Improve mood, resilience and mental wellbeing

Facilitators
• Psychologist
• Co-Facilitator

Duration
• 10 x 2 hour weekly sessions (held on consecutive weeks)

Session Structure
• Review of key topics from previous session/s
• Review of out of session work
• Presentation/discussion of new topic/s
• Break (15 minutes)
• Group exercises and discussions (practice of new skills)
• Setting of out of session work
• Session summary

Notes
• Participants will be recruited and screened prior to program commencement
• Program is designed to be highly interactive; commitment to group participation will be gained during recruitment and screening process

Session Topic Worksheets
1 Introduction
• Introduction to program
• Group values & introductions
• CBT model & weight conceptualisation
• Self-monitoring • Program outline
• CBT Model handout
• Self-Monitoring worksheet
2 Foundation (Education)
• CBT model
• Nutrition & eating
• Exercise & activity
• Mental health
• CBT Model handout
• Mind & Body Health handout
• Healthy Eating guideline
• Self-Monitoring worksheet
• Eating diary
3 Moving (Behavioural Strategies I)
• Values
• Goal-setting
• Increasing activity
• Structured problem-solving
• Personal Values handout
• Increasing Activity handout
• Activity schedule
• Goal-Setting worksheet
• Problem-Solving handout
• Self-Monitoring & Eating diary
4 Awareness (Behavioural Strategies II)
• Monitoring body cues
• Mindful eating
• Alternatives to comfort eating
• Monitoring Body Cues handout
• Mindful Eating handout
• Alternative Coping Strategies for Emotional Eating handout

5 Emotions (Emotional Regulation)
• Emotion and acceptance
• Stress and relaxation
• Emotions & Stress handout
• Acceptance / Meditation handout
• Relaxed Breathing handout
• PMR handout
6 Thinking (Cognitive Strategies I)
• Program review
• Unhelpful thought patterns
• Monitoring and identifying thoughts
• Thoughts, Feelings & Unhelpful Patterns handout
• Thought Monitoring worksheet
• Program Review worksheet
7 Challenging (Cognitive Strategies II)
• Challenging unhelpful thinking
• Thought Monitoring worksheet
• Thought Challenging Worksheet
8 Self-Value (Self-Worth/Body Image)
• Core beliefs
• Self-worth and body image
• Building worth and acceptance
• Self-Worth & Body Image handout
• Challenging Core Beliefs worksheet
• Celebrating Strengths worksheet
9 Bigger Picture (Broader Health)
• Sleep quality
• Support network
• Improving Sleep handout
• Social Health handout
10 Future Directions (Relapse Prevention)
• Program summary
• Planning for the future
• Participant presentations
• Program Summary handout
• Plan for Future worksheet
• Goal-Setting worksheet
• Program Evaluation sheet

We will record a list of attendance and make notes about participation following each session.
Intervention code [1] 298602 0
Prevention
Intervention code [2] 298603 0
Lifestyle
Intervention code [3] 298604 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302741 0
Change in Depression Symptoms

A change of Depression Scores using the Hamilton Depression Scale (range 0-52) > 5% .
Timepoint [1] 302741 0
Primary timepoint is following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Primary outcome [2] 302742 0
Self Esteem

A change of Self Esteem Scores using the Rosenberg Self Esteem Scale (score range 0-30) > 5% .
Timepoint [2] 302742 0
A Primary timepoint is following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Primary outcome [3] 302743 0
Dietary Changes

A change in scores of >10% of the Short Food Survey

Assessed using the Short Food Survey developed by the CSIRO
Dietary Questionnaire developed by the CSIRO - available online at CSIRO website:
https://my.totalwellbeingdiet.com/healthy-diet-score
(with permission)
Timepoint [3] 302743 0
A Primary timepoint is following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [1] 336889 0
Changes in Weight

A >5% change in bodyweight using weighing scales in KG
Timepoint [1] 336889 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [2] 337149 0
Change in anxiety symptoms

Using the Hamilton Anxiety Scale (range 0-56) - change of >5%
Timepoint [2] 337149 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [3] 337150 0
GPAQ

Changes in activity levels as measured by the GPAQ (Global Physical Activity Questionnaire - WHO) > 5%
Timepoint [3] 337150 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [4] 337151 0
Eating Behaviour

Change in score using The Three Factor Eating Questionnaire (range 18-72) >5%
Timepoint [4] 337151 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [5] 337153 0
Health Self Efficacy

Changes in score of SF36 Health Survey (8 domains - all between 0-100%): >5% in all of the domains. Each will be assessed separately for changes.
Timepoint [5] 337153 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [6] 337159 0
Alcohol Use

Changes in alcohol use, measured with AUDIT questionnaire (range 0-40) > 5%
Timepoint [6] 337159 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [7] 337161 0
Body Image

As measured by the BSQ34 (range 34-204) Change >10%
Timepoint [7] 337161 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.
Secondary outcome [8] 337162 0
Sleep Changes

Measured using the Pittsburgh Sleep Quality Index (range is 0-27) Change of >5%
Timepoint [8] 337162 0
Following the end of the 10 week group programme, As soon as practicable after the groups but within 2 weeks. Other timepoints include - baseline prior to group commencement, and then follow up at 3 months, 12 months post 10 week intervention.

Eligibility
Key inclusion criteria
Participants
• 8 – 15 participants per group (permitting for 30% dropout during the course)
• BMI range >25 – (overweight and obesity)
• Diagnosis of depression (as per clinical assessment using HAM D) >8
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other Serious Mental Health Disorders such as Schizophrenia, Bipolar Disorder, Mania

Other Serious Physical Disorders that would have current physiological effects on weight or mood, such as cancer, thyroid disorders, or other major physical conditions.

Must be able to travel to and from the venue and to commit to 10 week programme.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Provided on a first come first serve basis, provided they meet criterion through a telephone interview based questionnaire.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Simple difference in scores and increase or decrease in behavioural change. It is a small trial, each group consisting between eight and twelve participants. There will be two groups held over the next 12 months. Participants will have a baseline assessment; a six month assessment and a 12 month assessment using the same series of questionnaires.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
1/05/2021
Actual
1/02/2018
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
42
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 16635 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296986 0
Other Collaborative groups
Name [1] 296986 0
SAHMRI Mind & Brain Theme
Country [1] 296986 0
Australia
Primary sponsor type
Other
Name
SAHMRI
Address
South Australian Health and Medical Research Institute
Mind & Brain Theme
Level 7
North Terrace,
Adelaide 5000
Country
Australia
Secondary sponsor category [1] 295988 0
None
Name [1] 295988 0
Address [1] 295988 0
Country [1] 295988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298185 0
Social and Behavioural Research Ethics Committee (SBREC)
Ethics committee address [1] 298185 0
Ethics committee country [1] 298185 0
Australia
Date submitted for ethics approval [1] 298185 0
05/04/2017
Approval date [1] 298185 0
05/05/2017
Ethics approval number [1] 298185 0
7601

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1882 1882 0 0
/AnzctrAttachments/373299-Ethics Approval 7601.pdf (Ethics approval)
Attachments [2] 1883 1883 0 0
/AnzctrAttachments/373299-Participant Information Sheet Depression & Overweight - Clean Copy FINAL 27-04-17.pdf (Participant information/consent)
Attachments [3] 1884 1884 0 0
/AnzctrAttachments/373299-Consent Form Depression & Overweight - Clean Copy FINAL 27-04-17.pdf (Participant information/consent)
Attachments [4] 1885 1885 0 0
/AnzctrAttachments/373299-2 - diet&depression Flinders Ethics Application bw signed v1 27-2-2017.pdf (Protocol)
Attachments [5] 1886 1886 0 0
/AnzctrAttachments/373299-Recruitment Advert - Depression & Overweight - version1 27-2-17.pdf (Other)

Contacts
Principal investigator
Name 76254 0
Dr Michael Musker
Address 76254 0
Mind & Brain Theme,
SAHMRI
Level 7
North Terrace
Adelaide
SA 5000
Country 76254 0
Australia
Phone 76254 0
+61881284714
Fax 76254 0
Email 76254 0
[email protected]
Contact person for public queries
Name 76255 0
Michael Musker
Address 76255 0
Mind & Brain Theme,
SAHMRI
Level 7
North Terrace
Adelaide
SA 5000
Country 76255 0
Australia
Phone 76255 0
+61881284714
Fax 76255 0
Email 76255 0
[email protected]
Contact person for scientific queries
Name 76256 0
Michael Musker
Address 76256 0
Mind & Brain Theme,
SAHMRI
Level 7
North Terrace
Adelaide
SA 5000
Country 76256 0
Australia
Phone 76256 0
+61881284714
Fax 76256 0
Email 76256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have provide a summary of the results only. We did not obtain participants permission to share line by line details.


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
EmbasePilot trial of a group cognitive behavioural therapy program for comorbid depression and obesity.2020https://dx.doi.org/10.1186/s40359-020-00400-w
N.B. These documents automatically identified may not have been verified by the study sponsor.