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Trial registered on ANZCTR


Registration number
ACTRN12616000258459
Ethics application status
Approved
Date submitted
19/02/2016
Date registered
24/02/2016
Date last updated
12/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Mindfulness-Based Program for Depression and Anxiety: a pilot trial of an online intervention
Scientific title
A Pilot Trial evaluating the impact of mindfulness-enhanced internet-delivered cognitive behavioural therapy (MEiCBT) on symptoms of depression and anxiety
Secondary ID [1] 286530 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 294753 0
Generalized Anxiety Disorder 294754 0
Social Anxiety Disorder 294755 0
Panic Disorder with or without Agoraphobia 294756 0
Obsessive Compulsive Disorder 297736 0
Condition category
Condition code
Mental Health 295036 295036 0 0
Depression
Mental Health 295037 295037 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Mindfulness-Based Program comprises 7 lessons completed over 14 weeks. It includes all treatment components typically seen in face-to-face cognitive behavioural therapy (CBT), as well as a number of formal and informal mindfulness exercises (including guided mindfulness meditations (provided on a CD) and written instruction for using mindfulness in daily life). One lesson will be released every 7 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons), with each participant taking between one and two weeks to each lesson (14 weeks in total). Each lesson will take approximately 30-40 minutes to complete. Participants will have access to summaries of each lesson, homework exercises, extra resources, for each lesson. Participants are advised to spend at least 3-4 hours per week working through the lesson material, revisiting the content and homework tasks/ practicing the skills. Clinician guidance will be provided in the form of email or phone contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is able to email or phone the clinician at any point during the trial. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations, the clinician is automatically alerted and initiates contact with the participant by phone or email. This mode of contact is dependent on what is clinically indicated in terms of the participant's distress score and or what the participant may have communicated (in the form of phone or email contact) to the clinician. The mode of contact (email or phone or both) therefore is dependent on the clinician's clinical judgement of the situation in hand.
Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 291619 0
Behaviour
Intervention code [2] 291620 0
Treatment: Other
Comparator / control treatment
N/A This is an uncontrolled pre-post study design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294798 0
Changes in depression symptoms (according to mean scores on the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 294798 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Primary outcome [2] 294799 0
Changes in anxiety symptoms according to mean scores on the Generalised Anxiety Disorder 7-item scale (GAD-7).
Timepoint [2] 294799 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [1] 314065 0
Changes in psychological distress according to mean scores on the Kessler-10 (K10).
Timepoint [1] 314065 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [2] 314066 0
Changes in in functional impairment and disability according to mean scores on the World Health Organisation Disability Assessment Schedule (WHODAS-II).
Timepoint [2] 314066 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [3] 314067 0
Changes in worry frequency according to mean scores on the Penn State Worry Questionnaire (PSWQ)
Timepoint [3] 314067 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [4] 314068 0
Changes in rumination frequency according to mean scores on the Ruminative Responses Scale (RRS)
Timepoint [4] 314068 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [5] 314070 0
Reductions in experiential avoidance according to the Brief Experiential Avoidance Questionnaire (BEAQ)
Timepoint [5] 314070 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [6] 314071 0
Changes in in emotion regulation according to mean scores on the Difficulties with Emotion Regulation Scale (DERS)
Timepoint [6] 314071 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [7] 314072 0
Changes in mindfulness according to mean scores on the Five-Factor Mindfulness Questionnaire (FFMQ)
Timepoint [7] 314072 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [8] 314073 0
Changes in well-being according to mean scores on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Timepoint [8] 314073 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [9] 314074 0
Treatment Satisfaction according to the scores on the Treatment Satisfaction
Questionnaire.
Timepoint [9] 314074 0
one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks
Secondary outcome [10] 314103 0
Changes in severity of social anxiety according to mean scores on the Mini Social Phobia Inventory (mini-SPIN).
Timepoint [10] 314103 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)
Secondary outcome [11] 314104 0
Changes in the severity of panic disorder symptoms according to mean scores on the Panic Disorder Severity Scale (PDSS).
Timepoint [11] 314104 0
Baseline, mid-treatment (before Lesson 5), one week post-treatment - either one week after the participant has completed the 7 lessons (as they may have completed one lesson per week of the program) or one week after the 14 weeks, and at 3-month post-treatment (week 24)

Eligibility
Key inclusion criteria
* Self-identified as suffering from depression and/or anxiety.
* Meet criteria for either Major Depressive Disprder (MDD), Generalized Anxiety Disorder (GAD), Social Phobia (SP), Panic Disorder (PD), Agoraphobia (AG), or Obsessive-Compulsive Disorder (OCD) according to the Mini International Neuropsychiatric Interview Version 5.0.0 (MINI)
* Australian resident status
* At least 18 years of age
* Access to a computer, printer, and the internet
* If taking medication, must have been taking the same dose for at least 1 month and not intend to change that dose during the course of the program.
* Prepared to provide name, phone number, and address, and to provide the name and phone number of a local general practitioner.
* Willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Does not meet diagnostic criteria for an anxiety or depressive disorder.
- Currently experiencing severe depression symptoms (score of 23 or above on the PHQ-9).
- Regularly using illicit drugs or regularly consuming more than three standard drinks per day
- Current regular use of benzodiazepines
- Current use of atypical anti-psychotics
- Currently experiencing a psychotic mental illness or bipolar disorder
- Completed an online program for depresison and/or anxiety in the past year
- Severe symptoms of suicidal ideation (defined as responding 3 to the PHQ-9 question 9 item that assesses the frequency of suicidal ideation over the past fortnight).
-Those scoring 1 or 2 on the Patient Health Questionnaire_9 Item (PHQ-9) item 9 will require risk assessment with the responsible clinician before being admitted into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online, followed by a telephone interview to confirm diagnosis via the Mini International Neuropsychiatric Interview Version 5.0.0 (MINI) a structured clinical interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a non-randomised study. All participants that meet criteria for entry into the study who also provide informed consent will be allocated to the intervention (MEiCBT) group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A pre-to-post-treatment improvement of effect size (ES) 1.0 is expected for the treatment group on the primary depression and anxiety measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2015
Date of last participant enrolment
Anticipated
Actual
9/03/2015
Date of last data collection
Anticipated
Actual
20/11/2015
Sample size
Target
25
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291090 0
Self funded/Unfunded
Name [1] 291090 0
Country [1] 291090 0
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 289769 0
None
Name [1] 289769 0
None
Address [1] 289769 0
Country [1] 289769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292672 0
St Vincent's Hospital HREC
Ethics committee address [1] 292672 0
St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 292672 0
Australia
Date submitted for ethics approval [1] 292672 0
30/05/2014
Approval date [1] 292672 0
19/06/2014
Ethics approval number [1] 292672 0
HREC/14/SVH/170

Summary
Brief summary
The project aims to explore the efficacy, acceptability and feasibility of an internet-delivered mindfulness-enhanced cognitive behavioural therapy (MEiCBT) program for depression and anxiety.

Up to 30 people with elevated depression and/or anxiety will be assigned to the active treatment group. The treatment group will commence the Mindfulness-Based Program for Depression and Anxiety immediately.

The efficacy of the program will be determined by comparing the depression and/or anxiety symptom levels before and after treatment, and at 3 month follow-up.
Trial website
Trial related presentations / publications
Follow-up continuing, no data analysis or publication write up until after completion of follow-ups.
Public notes

Contacts
Principal investigator
Name 56538 0
Prof Gavin Andrews
Address 56538 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Level 4 O'Brien Centre, 390 Victoria St Darlinghurst NSW 2010
Country 56538 0
Australia
Phone 56538 0
+61 2 8382 1405
Fax 56538 0
Email 56538 0
gavina@unsw.edu.au
Contact person for public queries
Name 56539 0
Miss Natalie Kladnitski
Address 56539 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Level 4 O'Brien Centre, 390 Victoria St Darlinghurst NSW 2010
Country 56539 0
Australia
Phone 56539 0
+61 2 8382 1437
Fax 56539 0
Email 56539 0
Natalie.Kladnitski@svha.org.au
Contact person for scientific queries
Name 56540 0
Miss Natalie Kladnitski
Address 56540 0
Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Level 4 O'Brien Centre, 390 Victoria St Darlinghurst NSW 2010
Country 56540 0
Australia
Phone 56540 0
+61 2 8382 1437
Fax 56540 0
Email 56540 0
Natalie.Kladnitski@svha.org.au

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
SourceTitleYear of PublicationDOI
EmbaseOnline mindfulness-enhanced cognitive behavioural therapy for anxiety and depression: Outcomes of a pilot trial.2018https://dx.doi.org/10.1016/j.invent.2018.06.003
N.B. These documents automatically identified may not have been verified by the study sponsor.