Bipolar Affective Disorder, Hypomania, Mania
Conditions
Keywords
mania, hypomania, bipolar affective disorder, psychological intervention, cognitive therapy
Brief summary
There is a need to develop a better understanding of the early phase of bipolar disorder, and to develop and evaluate effective psychosocial interventions that assist people in this phase. The purpose of this study is to determine whether or not it is feasible to conduct a larger study of the effectiveness of cognitive interpersonal therapy (a psychological therapy) with individuals who have experienced their first or second treated episode of mania or hypomania (symptoms common in early development of bipolar disorders).
Detailed description
The 'PICO' framework (Oxman, Sackett, and Guyatt, 1993; Richardson, Wilson, Nishikawa, and Hayward; 1995) was used to specify the parameters of the study aims and objectives: 1. Population: could appropriate individuals be identified and recruited to a trial of CIT for early bipolar disorder? 2. Intervention: would CIT be an acceptable intervention for individuals following a first or second treated episode of mania and or hypomania? Could we identify any modifications required to the CIT protocol used with this group? 3. Control group: could an appropriate group of participants be recruited to facilitate a comparison with the CIT intervention? Could we explicitly establish the usual care package and its local implementation? 4. Outcomes: which outcomes are appropriate for measuring relevant dimensions of a treatment effect?
Interventions
OTHERCognitive Interpersonal Therapy
Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
OTHERTreatment As Usual
The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
Sponsors
Chief Scientist Office of the Scottish Government
University of Glasgow
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible individuals will have experienced their first or second treated episode of mania and / or hypomania in the previous 12-months prior to study entry.
Exclusion criteria
* Participants will be excluded if there is a (1) diagnosis of learning disability; (2) inability to participate in psychotherapy/research due to acute medical condition or acute mania
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) | Baseline to End of Study. | The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression |
| Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] | Baseline to End of Study | The Bech-Rafaelsen Mania Rating Scale (BRMS) \[Bech et al, 1979\] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are: 0 to 15 - normal /symptom absent 15 to 20 - mild 21 to 28 - moderate \>34 - severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Internal State Scale (ISS) (Bauer et al, 1991) | monthly until October 2011 | The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200). The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows: Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania \>155 \>125 Mixed State \>155 \<125 Euthymia \<155 \>125 Depression \<155 |
| Global Assessment of Functioning (GAF) | monthly until October 2011 | Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were consecutively recruited from mental health services within the Glasgow. A total of 32 patients were referred to the study during the 9-month recruitment window between November 2010 and July 2011 (3.5 referrals/month). Of the 32 patients referred 23 consented to participate in the trial. This equates to a consent rate of 71.88%.
Pre-assignment details
Of the 32 individuals referred, 6 were not assessed as: 3 refused consent, 2 were unable to be contacted within recruitment window and 1 individual moved away from the study location. A further three individuals did not meet our inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Psychological Therapy Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006). | 10 |
| Treatment As Usual Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment As Usual | Psychological Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Continuous | 41.60 years STANDARD_DEVIATION 45.5 | 33.40 years STANDARD_DEVIATION 6.9 | 37.5 years STANDARD_DEVIATION 12.02 |
| Region of Enrollment United Kingdom | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 2 / 10 |
Outcome results
Primary
Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]
The Bech-Rafaelsen Mania Rating Scale (BRMS) \[Bech et al, 1979\] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are: 0 to 15 - normal /symptom absent 15 to 20 - mild 21 to 28 - moderate \>34 - severe
Time frame: Baseline to End of Study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychological Therapy | Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] | Baseline | 6.00 units on a scale | Standard Deviation 7.76 |
| Psychological Therapy | Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] | End of Study | 4.78 units on a scale | Standard Deviation 4.55 |
| Treatment As Usual | Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] | Baseline | 6.70 units on a scale | Standard Deviation 4.42 |
| Treatment As Usual | Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] | End of Study | 4.11 units on a scale | Standard Deviation 5.09 |
Comparison: Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.p-value: 0.996ANOVA
Primary
Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)
The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
Time frame: Baseline to End of Study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychological Therapy | Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) | Baseline | 26.20 units on a scale | Standard Deviation 12.12 |
| Psychological Therapy | Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) | End of Study | 16.11 units on a scale | Standard Deviation 11.82 |
| Treatment As Usual | Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) | Baseline | 20.20 units on a scale | Standard Deviation 13.92 |
| Treatment As Usual | Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) | End of Study | 15.22 units on a scale | Standard Deviation 16.66 |
p-value: 0.05ANOVA
Secondary
Global Assessment of Functioning (GAF)
Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities.
Time frame: monthly until October 2011
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychological Therapy | Global Assessment of Functioning (GAF) | Baseline | 57.90 units on a scale | Standard Deviation 20.4 |
| Psychological Therapy | Global Assessment of Functioning (GAF) | End of Study | 72.00 units on a scale | Standard Deviation 14.05 |
| Treatment As Usual | Global Assessment of Functioning (GAF) | End of Study | 70.56 units on a scale | Standard Deviation 16.45 |
| Treatment As Usual | Global Assessment of Functioning (GAF) | Baseline | 60.90 units on a scale | Standard Deviation 10.37 |
p-value: <0.05ANOVA
Secondary
The Internal State Scale (ISS) (Bauer et al, 1991)
The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200). The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows: Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania \>155 \>125 Mixed State \>155 \<125 Euthymia \<155 \>125 Depression \<155
Time frame: monthly until October 2011
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Activation (End of Study) | 131.11 units on a scale | Standard Deviation 108.45 |
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Well-being (Baseline) | 97.00 units on a scale | Standard Deviation 63.08 |
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Depression (End of Study) | 46.64 units on a scale | Standard Deviation 47.17 |
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Activation (Baseline) | 122.00 units on a scale | Standard Deviation 81.89 |
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Well-being (End of Study) | 127.78 units on a scale | Standard Deviation 67.97 |
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Depression (Baseline) | 76.00 units on a scale | Standard Deviation 68.02 |
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Perceived Conflict (Baseline) | 126.00 units on a scale | Standard Deviation 94.78 |
| Psychological Therapy | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Perceived Conflict (End of Study) | 142.00 units on a scale | Standard Deviation 94.84 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Perceived Conflict (Baseline) | 78.00 units on a scale | Standard Deviation 62.32 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Activation (End of Study) | 113.33 units on a scale | Standard Deviation 117.69 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Depression (End of Study) | 45.56 units on a scale | Standard Deviation 57.69 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Perceived Conflict (End of Study) | 94.44 units on a scale | Standard Deviation 105.37 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Well-being (End of Study) | 137.78 units on a scale | Standard Deviation 82.73 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Well-being (Baseline) | 181.00 units on a scale | Standard Deviation 53.84 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Activation (Baseline) | 114.00 units on a scale | Standard Deviation 86.31 |
| Treatment As Usual | The Internal State Scale (ISS) (Bauer et al, 1991) | ISS - Depression (Baseline) | 41.00 units on a scale | Standard Deviation 50.21 |
p-value: <0.05ANOVA