Condition category
Mental and Behavioural Disorders
Date applied
31/08/2011
Date assigned
31/08/2011
Last edited
27/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bipolar disorder, previously known as “manic depression”, is a serious mental disorder characterised by extreme mood swings, alternating between mania (extreme highs) and depression (extreme lows). Bipolar disorder can look very different in different people, and so specific types have been proposed. Two of the most common types are known as bipolar I and II. Bipolar I is characterised by severe manic episodes, and bipolar II is characterised by severe depression alternating with episodes of hypomania (a very mild form of mania). Bipolar disorder can be managed using a combination of different treatments, such as with medication and therapy. Studies have shown that a particularly effective treatment is by teaching sufferers ways manage their moods day-to-day (integrated mood management). It is thought that this is most successful when a person is guided through the process by a trained facilitator (support worker). One of the cornerstones of this treatment is through routine “mood monitoring”, in which the sufferer keeps a log of their moods and the effects of different activities. “True Colours” is an online system that helps people to monitor their moods and experiences using text messages or e-mail. The aim of this study is to find out whether using “True Colours” is more effective when it is accompanied by support from a trained facilitator (Facilitated Integrated Mood Management, FIMM), or independently (Manualised Integrated Mood Management, MIMM).

Who can participate?
Adults with bipolar disorder I or II.

What does the study involve?
Participants are randomly allocated into one of two groups. The first group are given written information about how best to use True Colours and manage their symptoms day-to-day (MIMM). The second group are given five individual face-to-face sessions with a trained facilitator (FIMM), as well as several telephone calls to give additional support. Participants in both groups are asked to update True Colours every day for 12 months, as well as completing a questionnaire every week about how they are managing their moods.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Department of Psychiatry, Warneford Hosptial (UK)

When is the study starting and how long is it expected to run for?
September 2011 to September 2012

Who is funding the study?
National Institute of Health Research (UK)

Who is the main contact?
Professor Guy Goodwin
guy.goodwin@pysch.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Guy Goodwin

ORCID ID

Contact details

Department of Psychiatry
Warneford Hospital
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
+44 1865 226451
guy.goodwin@pysch.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10233

Study information

Scientific title

Randomised controlled trial of facilitated integrated mood management (FIMM) versus manualised integrated mood management (MIMM) in bipolar disorder

Acronym

OXTEXT-6

Study hypothesis

A randomised controlled trial (RCT) of the impact of different modes of delivery of Integrated Mood Management when delivered to bipolar patients together with True Colours, a symptom self-monitoring system which uses text messaging or e-mail. The two arms of the RCT will compare the efectiveness of Facilitated Integrated Mood Management (with support from a trained facilitator) with Manualised Integrated Mood Management (with no direct facilitator input).

Ethics approval

South Central – Oxford C approved on 21 April 2011, ref: 11/SC/0068

Study design

Randomised; Interventional and Observational; Design type: Treatment, Qualitative

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 contact oxtext@psych.ox.ac.uk to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder

Intervention

A new therapeutic intervention for use in bipolar disorder, known as Integrated Mood Management (IMM), has been developed by the research team. This is composed of five sessions which aim to educate patients to achieve better symptom control. IMM can be delivered either through individual face-to-face sessions with a facilitator (Facilitated Integrated Mood Management – FIMM), or by allowing the patient to work through the written materials independently (Manualised Integrated Mood Management – MIMM)

The randomised controlled trial examines the impact of the different modes of delivery of IMM, when used in conjunction with weekly symptom monitoring using True Colours, an electronic self-mood monitoring service which uses text messaging or E-mail. Patients using True Colours are requested to respond weekly to prompts using validated questionnaires that measure depressive symtoms using the Quick Inventory of Depressive Symptomology patient-rated version (QIDS-SR16) and manic symptoms using the Altman Self-Rating Mania Scale (ASRM). The two arms of the trial will compare the effectiveness of:
a) True Colours monitoring plus MIMM (no direct facilitator input); versus
b) True Colours monitoring plus FIMM (face-to-face support from a trained facilitator and several telephone contact ‘boosters-sessions’)

Both control and intervention arms are selected from patients aged 16 years or over who have a diagnosis of DSM-IV bipolar I or II and have demonstrated reliable participation in True Colours mood monitoring for >=4 weeks.

Follow Up Length: 12 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Quick Inventory of Depressive Symptomatology; Timepoint(s): 3 and 12 months after randomisation.

Secondary outcome measures

1. Altman Self-Rating Mania Scale; Timepoint(s): 3 and 12 months after randomisation
2. EuroQol EQ-5D; Timepoint(s): Monthly post randomisation
3. ICECAP-A questionnaire; Timepoint(s): Baseline and 3, 6,9 and 12 months
4. Medicines and health resource use questionnnaire; Timepoint(s): Baseline then 3,6,9 and 12 months
5. OxCAP-MH; Timepoint(s): Baseline and 12 months post randomisation
6. Self-management knowledge, understanding and action; Timepoint(s): Baseline and 3,6,9 and 12 months post randomisation
7. Time to recurrence; Timepoint(s): 3,6,9 and 12 months post randomisation

Overall trial start date

19/09/2011

Overall trial end date

19/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant in OXTEXT-1, and has opted into considering participation in further research studies
2. Participant is willing and able to give informed consent for participation in the study.
3. Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) bipolar I or II
4. Aged 16 or over
5. Reliable participation in True Colours mood monitoring for >=4 weeks (at least 3 out of 4 responses received for both Quick Inventory of Depressive Symptoms (QIDS) and Altman Self-Rating Mania (ASRM) over the last 4 weeks prior to invitation to participate).
6. Understanding of verbal and written English that is sufficient to participate in trial procedures, including integrated mood management (IMM).; Target Gender: Male & Female ; Lower Age Limit 16 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 156; UK Sample Size: 156;

Participant exclusion criteria

1. Current participant in OXTEXT- 2(because delivery of an additional intervention would confound the results of this pre- vs post-monitoring cost comparison study)
2. Treating psychiatrist or research team judge prospective participant to be acutely unwell to the extent that they cannot participate in IMM
3. Treating psychiatrist considers IMM to be inappropriate

Recruitment start date

19/09/2011

Recruitment end date

19/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychiatry
Warneford Hospital Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Nuffield Dept. Obstetrics and Gynaecology
Division of Medical Sciences
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Programme for Applied Research (Grant Codes: RP-PG-0108-10087)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22420594

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.