Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001324606
Ethics application status
Approved
Date submitted
8/12/2014
Date registered
17/12/2014
Date last updated
16/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Clinical Depression in Overweight & Obese Adults: A Tailored Cognitive Behavioural Approach.
Scientific title
A randomised control trial investigating the effect of a tailored cognitive behavioral therapy alone vs in conjunction with a novel exercise intervention on symptoms of depression in overweight and obese adults with clinical depression.
Secondary ID [1] 285804 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical Depression 293699 0
Overweight/Obesity 293700 0
Inflammation 293701 0
Condition category
Condition code
Mental Health 293999 293999 0 0
Depression
Diet and Nutrition 294000 294000 0 0
Obesity
Inflammatory and Immune System 294001 294001 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual Cognitive Behaviour Therapy administered by post-graduate students completing their Master of Clinical Psychology supervised by a Clinical Psychologist 1x1.5-2hrs per week for 10 weeks targeting issues common in depression and overweight/obesity (e.g. self-efficacy, withdrawal, body image, eating behaviours) with concurrent semi-structured physical exercise program of 45 minutes 3x per week for 10 weeks administered by trained 4th Year Exercise Science students. Adherence to treatment is monitored via audio/visual recordings for fidelity check to ensure treatment program is followed. Participant adherence will be monitored by therapist/trainer (record of attendance).
Intervention code [1] 290778 0
Lifestyle
Intervention code [2] 290817 0
Behaviour
Comparator / control treatment
Individual Cognitive Behaviour Therapy administered by post-graduate students completing their Master of Clinical Psychology under supervision of a Clinical Psychologist 1x1.5-2hrs per week for 10 weeks targeting issues common in depression and overweight/obesity (e.g. self-efficacy, withdrawal, body image, eating behaviours). Treatment As Usual (TAU) approach to Exercise intervention (i.e. 5x 45minute sessions with an exercise physiologist ('trainer') in addition to individual CBT with recommendations for suitable exercise plan and instruction on applicable exercise technique (HIIT/Personal Preference). Three sessions will occur in the first 5 weeks with the other two offered 'as desired' by the participant prior to the end of week 10. Sessions with an exercise physiologist will occur at their and the participants discretion.
Control group
Active

Outcomes
Primary outcome [1] 293784 0
% Change in Depression level as measured on the BDI-II
Timepoint [1] 293784 0
Measured fortnightly from week 0 to 10 and at follow up one and three months post treatment.
Primary outcome [2] 293785 0
% Change in Depression, Anxiety and Stress Scores as measured on the DASS-21
Timepoint [2] 293785 0
Measured every 5 weeks, 0, 5 and 10 and then at follow up at one month and 3 months post treatment.
Secondary outcome [1] 311823 0
% Change in inflammation as measured by finger prick blood sample (i.e. CRP, IL-6, TNF-a, IL-1, Interferon-y and IL-4)
Timepoint [1] 311823 0
Measured at Week 0 and Week 10.
Secondary outcome [2] 311824 0
% Change in Eating behaviours as measured on the Intuitive Eating Scale-23 and Binge Eating Scale
Timepoint [2] 311824 0
Week 0, 5, 10 and follow up at one and three months post treatment.
Secondary outcome [3] 311825 0
% Change in Self efficacy as measured by the New General Self Efficacy Scale and Exercise Self Efficacy Scale
Timepoint [3] 311825 0
Week 0, 5, 10 and one and three month follow up post treatment.
Secondary outcome [4] 311826 0
% Change in Self compassion and body image as measured by the Self Compassion Scale and Physical Self Description Questionnaire
Timepoint [4] 311826 0
Week 0, 5, 10 and at one month and three months post treatment.
Secondary outcome [5] 311827 0
% Change in body fat measured by DEXA
Timepoint [5] 311827 0
Week 0 and Week 10.

Eligibility
Key inclusion criteria
1. DSM Diagnosis of depression
2. Overweight or Obese (BMI: 25-35)
3. Willing and able to participate in exercise intervention
4. Older than 18 years of age, younger than 45 years of age.
5. Stable use of antidepressents (at least 3 weeks on regular dose)
6. No current engagement in therapy and willingness to postpone new therapy for the duration of participation
7. If female, must not be pregnant or attempting to become pregnant.
8. Understand written and spoken English (a conversational level of english is all that is required)
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Specific psychological disorders (Psychosis, Personality Disorder or Bipolar Disorders - either ICD-10 or DSM)
2. Previous cardiovascular incident (e.g. heart attack, stroke)
3. Current cardiovascular disease (i.e. CHD)
4. Serious or unstable medical conditions (other than obesity)
5. Substance dependence requiring rehabilitation/detoxification
6. Current suicidal ideation or recent attempt (previous 24months)

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)
Allocation concealment will be conducted using investigators blind to enrollment/allocation procedures. i.e. Participants will be de-identified upon enrollment (screened by an investigator blind to the study interventions). A new investigator will randomly assign the de-identified participant to an intervention group via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of two groups using a computerised random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Power analysis was conducted assuming alpha level of 0.05 and a moderate effect size (demonstrated in similar previous research .5-.7 low end indicates ~36pp extra to allow for 10-15% drop-out) Power = .95.

A 2 (group) x 3 (time) Repeated Measures ANOVA will be conducted. Physiological and anthropometric data will be collected pre and post intervention and will be analysed using a 2 (group) by 2 (time) one-way ANOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
22/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290369 0
University
Name [1] 290369 0
Murdoch University
Country [1] 290369 0
Australia
Primary sponsor type
Individual
Name
Nick Buckley
Address
Room 2-049 Social Sciences Building
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156 WA
Country
Australia
Secondary sponsor category [1] 289090 0
Individual
Name [1] 289090 0
Dr Helen Correia
Address [1] 289090 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156, WA
Country [1] 289090 0
Australia
Secondary sponsor category [2] 289091 0
Individual
Name [2] 289091 0
Dr Timothy Fairchild
Address [2] 289091 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156, WA
Country [2] 289091 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292072 0
Murdoch University
Ethics committee address [1] 292072 0
Ethics committee country [1] 292072 0
Australia
Date submitted for ethics approval [1] 292072 0
Approval date [1] 292072 0
14/11/2014
Ethics approval number [1] 292072 0
2014/220

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53342 0
Mr Nick Buckley
Address 53342 0
Social Sciences Building
Room 2-049
School of Psychology & Exercise Science Murdoch University 90 South St, Murdoch, 6156 WA
Country 53342 0
Australia
Phone 53342 0
+61 423611365
Fax 53342 0
Email 53342 0
[email protected]
Contact person for public queries
Name 53343 0
Helen Correia
Address 53343 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156 WA
Country 53343 0
Australia
Phone 53343 0
+61 08 9360 2290
Fax 53343 0
Email 53343 0
[email protected]
Contact person for scientific queries
Name 53344 0
Helen Correia
Address 53344 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156 WA
Country 53344 0
Australia
Phone 53344 0
+61 08 9360 2290
Fax 53344 0
Email 53344 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.