Trial Outcomes & Findings for Bipolar Intervention Study: Cognitive Interpersonal Therapy (NCT NCT01315028)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline to End of Study.

Results posted on

2014-07-30

Participant Flow

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%.

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.

Participant milestones

Participant milestones
Measure	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).	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.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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.
Overall Study Lost to Follow-up	1	0
Overall Study Death	0	1

Baseline Characteristics

Bipolar Intervention Study: Cognitive Interpersonal Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psychological Therapy n=10 Participants 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).	Treatment As Usual n=10 Participants 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.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	33.40 years STANDARD_DEVIATION 6.90 • n=5 Participants	41.60 years STANDARD_DEVIATION 45.50 • n=7 Participants	37.5 years STANDARD_DEVIATION 12.02 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United Kingdom	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Psychological Therapy n=9 Participants 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).	Treatment As Usual n=9 Participants 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.
Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) Baseline	26.20 units on a scale Standard Deviation 12.12	20.20 units on a scale Standard Deviation 13.92
Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) End of Study	16.11 units on a scale Standard Deviation 11.82	15.22 units on a scale Standard Deviation 16.66

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Psychological Therapy n=9 Participants 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).	Treatment As Usual n=9 Participants 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.
Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] Baseline	6.00 units on a scale Standard Deviation 7.76	6.70 units on a scale Standard Deviation 4.42
Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] End of Study	4.78 units on a scale Standard Deviation 4.55	4.11 units on a scale Standard Deviation 5.09

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Psychological Therapy n=9 Participants 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).	Treatment As Usual n=9 Participants 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.
The Internal State Scale (ISS) (Bauer et al, 1991) ISS - Perceived Conflict (Baseline)	126.00 units on a scale Standard Deviation 94.78	78.00 units on a scale Standard Deviation 62.32
The Internal State Scale (ISS) (Bauer et al, 1991) ISS - Well-being (Baseline)	97.00 units on a scale Standard Deviation 63.08	181.00 units on a scale Standard Deviation 53.84
The Internal State Scale (ISS) (Bauer et al, 1991) ISS - Activation (Baseline)	122.00 units on a scale Standard Deviation 81.89	114.00 units on a scale Standard Deviation 86.31
The Internal State Scale (ISS) (Bauer et al, 1991) ISS - Depression (Baseline)	76.00 units on a scale Standard Deviation 68.02	41.00 units on a scale Standard Deviation 50.21
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	94.44 units on a scale Standard Deviation 105.37
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	137.78 units on a scale Standard Deviation 82.73
The Internal State Scale (ISS) (Bauer et al, 1991) ISS - Activation (End of Study)	131.11 units on a scale Standard Deviation 108.45	113.33 units on a scale Standard Deviation 117.69
The Internal State Scale (ISS) (Bauer et al, 1991) ISS - Depression (End of Study)	46.64 units on a scale Standard Deviation 47.17	45.56 units on a scale Standard Deviation 57.69

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Psychological Therapy n=9 Participants 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).	Treatment As Usual n=9 Participants 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.
Global Assessment of Functioning (GAF) Baseline	57.90 units on a scale Standard Deviation 20.40	60.90 units on a scale Standard Deviation 10.37
Global Assessment of Functioning (GAF) End of Study	72.00 units on a scale Standard Deviation 14.05	70.56 units on a scale Standard Deviation 16.45

Adverse Events

Psychological Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment As Usual

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Psychological Therapy n=10 participants at risk 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).	Treatment As Usual n=10 participants at risk 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.
Psychiatric disorders Suicide	0.00% 0/10	10.0% 1/10 • Number of events 1
Psychiatric disorders Admission to psychiatric Hospital	0.00% 0/10	10.0% 1/10 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Professor Andrew Gumley

University of Glasgow

Phone: 0044 141 211 3927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place