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Pilot Study of the Effects of Circadian Rhythms on the Treatment of Bipolar I Depression.

NCT00726154 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-01-11

No results posted yet for this study

Summary

The objective of this pilot study is to test the feasibility of a larger planned trial. The objective of this larger trial will be to determine the extent to which aspects of circadian rhythmicity, including, sleep/wake rhythms, daily social routines (i.e., social rhythms), circadian type (morningness/eveningness), endogenous circadian rhythms and polymorphisms associated with altered circadian function in specific genes (namely, CLOCK, Period 2 and Period 3) moderate treatment response in bipolar disorder.

Conditions

Interventions

BEHAVIORAL

IPSRT

Interpersonal and social rhythm therapy (IPSRT) focuses specifically on rhythmicity. IPSRT is based on the social zeitgeber hypothesis (Ehlers et al., 1988; 1993) and the conviction that regularity of social routines and stability of interpersonal relationships have a protective effect in recurrent mood disorders. In IPSRT, resolution of depressive symptoms is theorized to come about through the exploration of the links among mood symptoms, stability of social rhythms and quality of social relationships and social role performance, and the identification and management of potential precipitants of rhythm disruption.

BEHAVIORAL

Collaborative Care

The collaborative care (CC) condition is a less intensive psychosocial intervention that was employed as the control condition in the STEP-BD study of psychosocial treatment (see Miklowitz et al., 2007). Participants assigned to this condition will receive a psychoeducational videotape and a workbook including information about: 1) the diagnosis, management, and treatment of bipolar illness; 2) the importance of medication adherence; 3) schedule management including daily mood charting; 4) typical biases in thinking relevant to mood states; 5) improving relationships through communication skills; and 6) developing a treatment contract geared toward preventing episodes.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Ellen Frank, Ph.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00726154 on ClinicalTrials.gov