An interventional study of Cognitive Interpersonal Therapy and Treatment As Usual in Mania, Hypomania and Bipolar Affective Disorder, sponsored by NHS Greater Glasgow and Clyde. Completed at 2 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-07-30.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
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).
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:
102 studies on the registry are indexed under Mania; 11 are open to participants now.
This study's enrollment of 20 is below the median of 82 across 88 interventional studies indexed under Mania.
Browse Mania studies →NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
Cognitive Interpersonal Therapy (CIT) was a psychological therapy which emphasised assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive-behavioural and interpersonal strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley \& Schwannauer, 2006).
Other: Cognitive Interpersonal Therapy
All participants continued to receive their usual care from their local community mental health team and other psychological therapies were not withheld during the conduct of the trial.
Other: Treatment As Usual
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).
Also known as: Psychological Therapy
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.
Also known as: Normal clinical care
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.
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
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
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
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%.
| Milestone | Psychological Therapy | Treatment As Usual |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Death | 0 | 1 |
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
| units on a scale | Psychological Therapy | Treatment As Usual |
|---|---|---|
| Baseline | 26.20 ± 12.12 | 20.20 ± 13.92 |
| End of Study | 16.11 ± 11.82 | 15.22 ± 16.66 |
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
| units on a scale | Psychological Therapy | Treatment As Usual |
|---|---|---|
| Baseline | 6.00 ± 7.76 | 6.70 ± 4.42 |
| End of Study | 4.78 ± 4.55 | 4.11 ± 5.09 |
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
| units on a scale | Psychological Therapy | Treatment As Usual |
|---|---|---|
| ISS - Perceived Conflict (Baseline) | 126.00 ± 94.78 | 78.00 ± 62.32 |
| ISS - Well-being (Baseline) | 97.00 ± 63.08 | 181.00 ± 53.84 |
| ISS - Activation (Baseline) | 122.00 ± 81.89 | 114.00 ± 86.31 |
| ISS - Depression (Baseline) | 76.00 ± 68.02 | 41.00 ± 50.21 |
| ISS - Perceived Conflict (End of Study) | 142.00 ± 94.84 | 94.44 ± 105.37 |
| ISS - Well-being (End of Study) | 127.78 ± 67.97 | 137.78 ± 82.73 |
| ISS - Activation (End of Study) | 131.11 ± 108.45 | 113.33 ± 117.69 |
| ISS - Depression (End of Study) | 46.64 ± 47.17 | 45.56 ± 57.69 |
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.
| units on a scale | Psychological Therapy | Treatment As Usual |
|---|---|---|
| Baseline | 57.90 ± 20.40 | 60.90 ± 10.37 |
| End of Study | 72.00 ± 14.05 | 70.56 ± 16.45 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psychological Therapy | — | 0/10 (0%) | 0/10 (0%) |
| Treatment As Usual | — | 2/10 (20%) | 0/10 (0%) |
| Event | Psychological Therapy | Treatment As Usual |
|---|---|---|
| SuicidePsychiatric disorders | 0/10 | 1/10 |
| Admission to psychiatric HospitalPsychiatric disorders | 0/10 | 1/10 |
| Age, Categorical(Participants) | Psychological Therapy | Treatment As Usual | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 9 | 9 | 18 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Psychological Therapy | Treatment As Usual | Total |
|---|---|---|---|
| Mean | 33.40 ± 6.90 | 41.60 ± 45.50 | 37.5 ± 12.02 |
| Sex: Female, Male(Participants) | Psychological Therapy | Treatment As Usual | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 3 | 3 | 6 |
| Region of Enrollment(participants) | Psychological Therapy | Treatment As Usual | Total |
|---|---|---|---|
| United Kingdom | 10 | 10 | 20 |
The record gives a start of Nov 2010, a primary completion of Oct 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2014, 2 years 9 months after primary completion.
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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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