Condition category
Mental and Behavioural Disorders
Date applied
14/07/2017
Date assigned
20/07/2017
Last edited
08/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bipolar disorders (BDs) are fairly common, affecting around 3-4% of people in the UK. They are very costly, both personally and economically. BDs often involve episodes of depression and mania lasting for weeks or months. Around half of people with BDs have more frequent swings in mood lasting for hours or days. These frequent mood swings impact on day-to-day coping and increase the chances of additional mental health conditions and full mania or depression. People with BDs often want psychological treatments, but so far these have focused mainly on the full bipolar episodes. A treatment that helps people with BDs to manage frequent mood swings could improve day-to-day mental health, and may even reduce the chance of a full episode developing. With input from patients and clinicians the ThrIVe-B programme has been developed to target frequent bipolar mood swings and the difficulties they can cause. There first needs to be a smaller study to help plan for a large study. The aim of this study is to assess the feasibility and acceptability of a future study evaluating the clinical and cost effectiveness of the ThrIVe-B programme for adults with frequent bipolar mood swings.

Who can participate?
Patients aged 18 or over with frequent bipolar mood swings across two locations (Exeter and Lancaster)

What does the study involve?
Participants are randomly allocated to receive either their usual treatment or usual treatment plus the ThrIVe-B programme. The ThrIVe-B programme involves a course of 16 two hour weekly sessions, with printed course notes, eight individual therapy sessions and use of a smartphone application. The course notes can be personalised and provide longer term support. In addition there is a "reunion" session three months after the programme has ended. The participants complete regular questionnaires and interviews to assess depression symptoms, mood swings, personal recovery and quality of life.

What are the possible benefits and risks of participating?
The results will help to plan for a full study that will ultimately test whether ThrIVe-B is effective and provides good value for money.

Where is the study run from?
1. University of Exeter (UK)
2. Devon Partnership Trust (UK)
3. Cumbria Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
June 2017 to August 2019

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

Who is the main contact?
1. Dr Alexandra Newbold
2. Dr Kim Wright

Trial website

Contact information

Type

Public

Primary contact

Dr Alexandra Newbold

ORCID ID

Contact details

Henry Wellcome Building
Streatham Campus
University of Exeter
Exeter
EX4 4QG
United Kingdom

Type

Scientific

Additional contact

Dr Kim Wright

ORCID ID

Contact details

University of Exeter Department of Psychology
Washington Singer Labs
Perry Road
Exeter
EX4 4QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.4

Study information

Scientific title

The clinical and cost effectiveness of adapted Dialectical Behaviour Therapy (DBT) for Bipolar Mood Instability in primary care (ThrIVe-B programme): a feasibility study

Acronym

ThrIVe-B

Study hypothesis

To assess the feasibility and acceptability of a future definitive randomised controlled trial (RCT) evaluating the clinical and cost effectiveness of a psychological therapy programme (informed by Dialectical Behaviour Therapy: DBT) for adults with frequent bipolar mood swings.

Ethics approval

South Yorkshire REC, 25/04/2017, ref: 17/YH/0105

Study design

Feasibility study with a two-arm randomised parallel controlled trial design

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Frequent mood swings within the context of a Bipolar Spectrum Disorder

Intervention

Following completion of the baseline assessment, eligible participants will be randomised on a 1:1 ratio (minimisation by trial site and medication status [currently prescribed medication for depression or Bipolar Disorder versus not prescribed such medication]) to:
1. Treatment as Usual (TAU) [control arm]
2. Treatment as Usual plus ThrIVe-B programme (TAU + ThrIVe-B ) [intervention arm]

The ThrIVe-B programme has been developed iteratively in consultation with ThrIVe-B patients and others with personal experience of BDs. It follows five key principles of DBT: i) clearly structured treatment; ii) application of behavioural therapy; iii) emphasis on validation of emotional response; iv) dialectical stance, balancing acceptance and change; v) integration of mindfulness practice. This is achieved structurally through a combination of group meetings (15, weekly) and up to 8 concurrent fortnightly individual sessions of up to 45 minutes delivered in person or by telephone.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

From 12/10/2017:

The primary aim of this study is to establish the feasibility of a future definitive trial; as such its aims are:
1. To establish recruitment pathways and trial teams in two trial sites (Devon/Exeter and Cumbria/Lancaster).
2. To inform the recruitment and timeline of a future fully-powered trial, by establishing the number of participants identified, approached, consented, randomised and completed.
3. To refine future trial procedures by establishing the acceptability and experience of the trial process to participants, including randomisation and completion of outcome measures.
4. To determine the optimal primary outcome measure in a future trial by assessing the performance of selected candidate primary outcome measures with respect to level of acceptability to participants (completion rates, perceived burden) and participant-perceived relevance and value.
5. To inform estimation of sample size for a future trial by measuring data completeness at follow up (participant attrition), standard deviation of the likely primary outcome measure, and the variability of the comparator condition, treatment as usual, across individuals and sites.
6. To inform the measurement of health economic outcomes in a future trial through piloting the use of a tool for identifying resource use and costs associated with delivery of the intervention.
7. To further assess the acceptability of the treatment via qualitative interviews and, based on input from trial participants and clinicians, to further refine and develop the treatment manual and the procedures for training, supervising and assessing the competence of trial therapists.

We will also evaluate whether the following continuation criteria have been met, prior to planning a future definitive trial:
1. Trial participation does not lead to serious negative consequences (unexpected serious adverse reaction) for our participants.
2. Any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a full trial.
3. Follow up data at 9 months is available from at least 60% of participants.
4. At least 60% of patients complete treatment (attend at least 50% of possible sessions).

Prior to 12/10/2017:

Symptom level, completed at baseline and 3, 6, 9, 15 months post baseline:
1. Current depression level, measured using Patient Health Questionnaire– 9
Symptom variability:
2. Self-reported tendency to experience labile mood, measured using the Affective Lability Scale
Quality of life and recovery status, completed at baseline and at 3, 6, 9, 15 months post baseline:
3. Personal recovery, measured using the Bipolar Disorder Recovery Questionnaire
4. Quality of life, measured using the Brief Quality of Life in Bipolar Disorder Scale

Secondary outcome measures

From 12/10/2017:

The outcome measures that will be evaluated within this feasibility study are as follows:

Symptom level, completed at baseline and 3, 6, 9, 15 months post baseline:
1. Current depression level, measured using Patient Health Questionnaire– 9
Symptom variability:
2. Self-reported tendency to experience labile mood, measured using the Affective Lability Scale
Quality of life and recovery status, completed at baseline and at 3, 6, 9, 15 months post baseline:
3. Personal recovery, measured using the Bipolar Disorder Recovery Questionnaire
4. Quality of life, measured using the Brief Quality of Life in Bipolar Disorder Scale

Symptom level, completed at baseline and 3, 6, 9, 15 months post baseline:
1. Current mania symptoms, measured using the Bech Mania Rating Scale
2. Current depressive symptoms, measured using the Hamilton Depression Scale
3. Anxiety symptoms, measured using the General Anxiety Questionnaire – 7

Health-related quality of life outcomes, completed at baseline and at 3, 9, 15 months post baseline:
The EuroQoL 5-Dimension 5 level (EQ-5D-5L) and the Short-Form-36 item (SF-36v.2) will be used to obtain utility scores for deriving Quality-Adjusted Life Years (QALYs) in order to estimate incremental cost effectiveness ratio in the planned future randomised controlled trial. In addition participants will be asked to complete a record of their recent health service usage.

Quantitative Process Measurement
To inform process measurement in a definitive trial, measures of hypothesised mechanisms of change will be included, providing data on their performance and acceptability to participants. Hypothesised treatment targets include mood-related impulsivity and avoidance, emotional acceptance, emotional problem solving, interpersonal functioning and social rhythm stability. Measures of these are described below.

Candidate self-report measures of therapy process, completed at baseline and at 3, 6, 9, 15 months post baseline:
1. Impulsive responding to positive mood, measured using UPPS-P
2. Behavioural avoidance and rumination, measured using the Behavioral Avoidance in Depression Scale
3. Mindfulness skill, measured using Kentucky Inventory of Mindfulness Skills
4. Regularity of daily routines, measured using the Adapted Social Rhythm Metric

Candidate behavioural measures of therapy process:
1. Means Ends Problem Solving Task (adapted to include social/emotional problem-solving) – this describes a problem and an end state/resolution and asks participants to describe the steps they would take to reach that end state (completed at baseline and at 9,15 months post baseline; at each point participants complete one of the four scenarios; these are counterbalanced across assessment points). Participants are given the option to complete this measure either with the researcher present (face to face or telephone) or on their own

Measures completed session by session by participants in ThrIVe-B + TAU condition:
2. Current manic symptom level, measured using the Altman Scale for Rating Mania
3. Current mania symptoms, measured using the Bech Mania Rating Scale

Prior to 12/10/2017:

Symptom level, completed at baseline and 3, 6, 9, 15 months post baseline:
1. Current mania symptoms, measured using the Bech Mania Rating Scale
2. Current depressive symptoms, measured using the Hamilton Depression Scale
3. Anxiety symptoms, measured using the General Anxiety Questionnaire – 7

Health-related quality of life outcomes, completed at baseline and at 3, 9, 15 months post baseline:
The EuroQoL 5-Dimension 5 level (EQ-5D-5L) and the Short-Form-36 item (SF-36v.2) will be used to obtain utility scores for deriving Quality-Adjusted Life Years (QALYs) in order to estimate incremental cost effectiveness ratio in the planned future randomised controlled trial. In addition participants will be asked to complete a record of their recent health service usage.

Quantitative Process Measurement
To inform process measurement in a definitive trial, measures of hypothesised mechanisms of change will be included, providing data on their performance and acceptability to participants. Hypothesised treatment targets include mood-related impulsivity and avoidance, emotional acceptance, emotional problem solving, interpersonal functioning and social rhythm stability. Measures of these are described below.

Candidate self-report measures of therapy process, completed at baseline and at 3, 6, 9, 15 months post baseline:
1. Impulsive responding to positive mood, measured using UPPS-P
2. Behavioural avoidance and rumination, measured using the Behavioral Avoidance in Depression Scale
3. Mindfulness skill, measured using Kentucky Inventory of Mindfulness Skills
4. Regularity of daily routines, measured using the Adapted Social Rhythm Metric

Candidate behavioural measures of therapy process:
1. Means Ends Problem Solving Task (adapted to include social/emotional problem-solving) – this describes a problem and an end state/resolution and asks participants to describe the steps they would take to reach that end state (completed at baseline and at 9,15 months post baseline; at each point participants complete one of the four scenarios; these are counterbalanced across assessment points). Participants are given the option to complete this measure either with the researcher present (face to face or telephone) or on their own

Measures completed session by session by participants in ThrIVe-B + TAU condition:
2. Current manic symptom level, measured using the Altman Scale for Rating Mania
3. Current mania symptoms, measured using the Bech Mania Rating Scale

Overall trial start date

06/06/2017

Overall trial end date

05/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Lifetime diagnosis of Bipolar Disorder (I,II, "other specified bipolar disorder") or Cyclothymic Disorder, according to DSM-V
3. Current bipolar mood instability (defined as per DSM-V criteria 1 and 2 for Cyclothymic Disorder or a score of 1.3 on the Bipolar subscale of the Affective Lability Scale, a self-report measure of mood instability)
4. Client wishes to engage in psychological therapy that focusses primarily on ongoing mood instability and its consequences
5. In lifetime must have experienced at least a two-day period in which symptom criteria for hypomania were met. This is to ensure that we are offering the intervention to individuals with a likely vulnerability to a Bipolar Disorder, rather than emotional instability solely attributable to Borderline Personality Disorder (as frequent mood swings seen in people experiencing Borderline Personality Disorder can sometimes be mistaken for Bipolar mood swings)
6. Sufficient competency in English to be able to complete study measures without the need for translation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Current alcohol or substance dependence (as this would indicate other treatment would be more appropriate)
2. Currently receiving other psychological therapy for bipolar disorder
3. Current high risk of suicide, or recent, frequent, significant self-harming behaviour (more than one instance requiring some form of treatment by self or others in the past month)
4. Evidence the individual may pose a significant risk to other group members, or has a pattern of interpersonal behaviour likely to be severely disruptive within a group setting (clinicians will be asked to apply this criterion when considering whether to approach individuals on their caseload regarding trial participation)
5. The person lacks capacity to consent to treatment or research participation
6. Current DSM-V mania or major depression
7. Individual is receiving ongoing co-ordinated care in secondary mental health services (as this intervention is aimed at individuals with difficulties not complex or severe enough to require ongoing multi-disciplinary mental health support and care co-ordination)

Recruitment start date

10/08/2017

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sir Henry Wellcome Building for Mood Disorders Research
University of Exeter Perry Road
Exeter
EX4 4QG
United Kingdom

Trial participating centre

Devon Partnership Trust
Wonford House
Exeter
EX2 5AF
United Kingdom

Trial participating centre

Cumbria Partnership NHS Foundation Trust
Voreda Portland Place
Penrith
CA11 7BF
United Kingdom

Sponsor information

Organisation

Devon Partnership NHS Trust

Sponsor details

Wonford House
Dryden Road
Exeter
EX2 5AF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication to peer reviewed journal by August 2020.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository within the University of Exeter by the end of 2019. Anonymised data may be accessed and analysed by members of the project team and with researchers collaborating with members of the project team on the analysis of these data. With the exception of anonymised quotes from research interviews, consent from participants was not sought for sharing raw data publicly. Therefore, external researchers seeking to access the data for use in future projects must do so via request to the Chief Investigator (or her delegate), and projects using the data must have been approved in accordance with contemporary U.K. ethical and regulatory processes pertaining to the release of anonymised data under these circumstances.

Intention to publish date

01/08/2020

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/01/2018: IPD statement clarified. 12/10/2017: The recruitment start date was changed from 17/07/2017 to 10/08/2017. The changes to the primary outcome measures were made as a correction, to bring this record in line with the study protocol approved by HRA prior to the start of recruitment (dated 26/05/2017) and to clarify that the primary aims concern feasibility.