Condition category
Mental and Behavioural Disorders
Date applied
23/05/2011
Date assigned
30/11/2011
Last edited
27/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In this study we aim to find out whether a mindfulness-based cognitive therapy course for parents (MBCT-P) is helpful in reducing levels of depression and parental stress. We are also interested in whether this therapy has any effect on parenting and children’s behaviour. This study will give us an initial understanding of whether this therapy could be helpful and therefore allow us to see whether a larger study can take place.

Who can participate?
Men and women aged 18 or over who have experienced three or more depressive episodes in the past, are in full or partial remission from depression, and have a child between the ages of 2 – 6.

What does the study involve?
Participants will be randomly allocated into one of two groups. The first group will receive the MBCT-P therapy course and the second group will continue with any care which they currently receive (in some cases they may not be receiving any care). If you are interested in taking part you will initially talk to a researcher over the phone and then meet them in order to answer some questions which will help us to see if you are eligible to take part. If you are eligible you will then complete a short interview and some questionnaires both at the beginning of the trial and 4 months and 9 months after you are allocated to a group. You will also be asked if you are happy to complete questionnaires weekly during the time that the therapy group is taking place. This helps us to compare the two groups over this time period.

What are the possible benefits and risks of participating?
Everyone who takes part will have a chance to take part in an MBCT group for parents (dependent on whether they are allocated to the therapy group). Although no one who takes part will be currently experiencing an episode of depression they may be experiencing some symptoms of depression. If anyone is thought to be at risk to themselves or anyone else then their GP or another appropriate clinician will be informed.

Where is the study run from?
Peninsula College of Medicine and Dentistry (UK).

When is the study starting and how long is it expected to run for?
From April 2011 to January 2012.

Who is funding the study?
Medical Research Council (MRC) (UK).

Who is the main contact?
Joanna Mann
joanna.mann@pcmd.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Joanna Mann

ORCID ID

Contact details

Peninsula College of Medicine and Dentistry
Veysey Building
Salmon Pool Lane
Exeter
EX2 4SG
United Kingdom
-
joanna.mann@pcmd.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.2

Study information

Scientific title

Mindfulness Based Cognitive Therapy for parents with recurrent depression: an exploratory randomised controlled trial

Acronym

MBCT-P

Study hypothesis

The trial aims to assess whether it is feasible to progress onto a definitive trial to explore the effectiveness of MBCT-P and whether MBCT-P is acceptable to parents with recurrent depression.

Ethics approval

South West 3 Research Ethics Committee, 27/01/2011, ref: 10/H0106/81

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Recurrent depression

Intervention

The MBCT-P trial has two arms. Participants allocated to the treatment arm take part in a baseline assessment and then recieve eight weeks of therapy, which consists of a 2 hour 15 minute (two of the sessions are 2 hours and 30 minutes) therapy session each week. They will take part in follow-ups at four and nine months post randomisation.

Participants randomlly allocated to usual care will have a baseline assessment and then continue with any care they currently receive and any which they decide to start during the trial. They will also have assessments at four and nine months post randomisation.

All participants will also complete questionnaires during the eight weeks which the therapy is taking place (regardless of arm).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Depressive symptoms as measured by the The Beck Depression Inventory (BDI-II)

Secondary outcome measures

1. Parenting stess as measured by the Parenting Stress Index, Short Form (PSI-SF)
2. Childrens' behaviour as measured by the Eyberg Child Behavior Inventory (ECBI) and Strengths and Difficulties Questionnaire (SDQ)
3. Quality of life
4. Explore whether changes in levels of mindfulness skills could be a possible mechanism of change:
4.1. Quantitative measurement of potential mediating variables
4.2. A parent observational study
4.3. An embedded qualitative study to elicit participants' experiences of treatment
All outcome measures will be taken at baseline, 4 and 9 months post randomisation

Overall trial start date

20/02/2011

Overall trial end date

30/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis of full or partial resmission from depression according to the Diagnostic and Statistical Manual for Mental Disorders Fourth Edition (DSM-IV-TR)
2. Age 18 years +
3. A parent (mother or father) of a child aged between 2 - 6 years
4. Have experienced 3 or more previous major depressive episodes according to the Diagnostic and Statistical Manual for Mental Disorders fourth addition DSM-IV-TR

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Current substance dependence
2. Organic brain damage
3. Current or past psychosis including bipolar disorder
4. Anti-social behaviour or persitant self-harm
5. Already receieving psychological therapy
6. Significant longstanding interpersonal difficulties that require specialist and long-term psychological treatment
7. A parent of a child who is known to be vulnerable or at risk

Recruitment start date

20/02/2011

Recruitment end date

30/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Peninsula College of Medicine and Dentistry
Exeter
EX2 4SG
United Kingdom

Sponsor information

Organisation

University of Exeter (UK)

Sponsor details

c/o Michael Wykes
Research and Knowledge Transfer
Innovation Centre
Exeter
EX4 4RN
United Kingdom
-
rkt@ex.ac.uk

Sponsor type

University/education

Website

http://www.exeter.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes