N/A
Completed N=20
Bipolar Intervention Study: Cognitive Interpersonal Therapy
Mania · Hypomania · Bipolar Affective Disorder
Source: ClinicalTrials.gov NCT01315028 ↗
Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Jul 2014
Primary outcomePrimary: Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) — 26.20; 20.20; 16.11; 15.22 units on a scale — p=0.05
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979) |
26.20; 20.20; 16.11; 15.22 | 0.05 |
| PRIMARY Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] |
6.00; 6.70; 4.78; 4.11 | 0.996 |
| SECONDARY The Internal State Scale (ISS) (Bauer et al, 1991) |
126.00; 78.00; 97.00; 181.00; 122.00; 114.00 | <0.05 sig |
| SECONDARY Global Assessment of Functioning (GAF) |
57.90; 60.90; 72.00; 70.56 | <0.05 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01315028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.