ThrIVe-B feasibility study

Not Applicable

• Conditions: Frequent mood swings within the context of a Bipolar Spectrum Disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN54234300
• Lead Sponsor: Devon Partnership NHS Trust

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30326960 protocol

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-20
• Study Completion: 2019-11-05
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 43

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified