Frequent mood swings within the context of a Bipolar Spectrum Disorder Mental and Behavioural Disorders
Conditions
Interventions
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 depressi
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 de
Sponsors
Devon Partnership NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/05/2018: 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 7. Registered with a GP practice in the catchment area served by the NHS Trusts involved in the study 8. Able and willing to regularly attend the group therapy session as scheduled Previous 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
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 30/05/2018: 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 indicates at any time pre-randomisation that they are unable or unwilling to attend the group therapy session that are scheduled Previous 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 coordinated care in secondary mental health services (as this intervention is aimed at individuals with difficulties not complex or severe enough to require ongoing multidisciplinary mental health support and care coordination)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 negativ | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, e | — |
Countries
United Kingdom
Contacts
Public ContactKim;Alexandra Wright;Newbold
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Outcome results
None listed