Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder
1 other identifier
interventional
17
1 country
1
Brief Summary
Anhedonia, characterized as (a) the diminished motivation to participate in activities, and/or (b) diminished enjoyment of a pleasurable activity are common symptoms among women diagnosed with mood disorders. This trial aims to test three treatments adapted to reduce anhedonia. The investigators will compare three treatment groups, specifically, two doses of Behavioral Activation treatment for anhedonia (i.e., 12 weeks vs. 8 weeks of BA) with an active comparator treatment, Bipolar Disorder Collaborative Care (12 weeks of BDCC). BA is a psychotherapy approach that helps participants to identify and modify environmental sources of their depression. BDCC is a supportive care approach that educates participants to optimize their medication initiation or their existing medication regimen. The time frame for this study will be between 12-14 weeks. Specifically, participants will be evaluated and enrolled within one week, then received up to 12 weeks of treatment (tracked through this time) and then complete two evaluations (one at week 8) and another at the end of treatment (an expected average of 12-14 weeks after enrolling into treatment). Primary analyses aim to compare the dose-mechanism change in BA relative to a standard medication optimizing protocol, BDCC. The secondary analyses are to evaluate individual differences in stated patient preferences for treatment, and group differences in treatment effect on anhedonia, side effects, and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 30, 2016
September 1, 2016
1.2 years
June 30, 2015
September 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Snaith-Hamilton Pleasure Scale-Clinician Version
Clinician-administered measure of anhedonia spanning the domains of: interests, social interaction, sensory experience, and food/drink.
approximately 12-14 weeks after enrolling into the treatment
Secondary Outcomes (2)
Inventory of Depressive Symptomatology-Clinician
approximately 12-14 weeks after enrolling into the treatment
Clinician-Administered Rating Scale for Mania
approximately 12-14 weeks after enrolling into the treatment
Study Arms (3)
Behavioral Activation-Full
EXPERIMENTALTwelve weekly sessions of phone therapy using Behavioral Activation Treatment for Anhedonia.
Behavioral Activation-Short
EXPERIMENTALEight weekly sessions of phone therapy using Behavioral Activation Treatment for Anhedonia.
Bipolar Disorder Collaborative Care
ACTIVE COMPARATORTwelve weekly sessions of phone therapy using BDCC manual adapted for anhedonia.
Interventions
Behavioral Activation proposes that symptom reduction occurs via monitoring daily activities to identify patterns of low reward and mood, assessing and assigning tasks that generate pleasure and competence, understanding and reducing unproductive avoidance, and improving skill deficits to promote action towards treatment goals.
Behavioral Activation proposes that symptom reduction occurs via monitoring daily activities to identify patterns of low reward and mood, assessing and assigning tasks that generate pleasure and competence, understanding and reducing unproductive avoidance, and improving skill deficits to promote action towards treatment goals.
This manualized treatment focuses on social support and educating patients about medication compliance. The primary focus is to strengthen the patients' self-management skills with education; supporting the clinician's decision making using practice guidelines; enhancing access to care, continuity of care, and information flow through the use of the clinician.
Eligibility Criteria
You may qualify if:
- Currently experiencing a score ≥ 20 on a clinician-administered scale of anhedonia
- Currently experiencing two or more symptoms of depression with bipolar disorder either Type I or II (one of these symptoms should be anhedonia) OR
- Currently experiencing two or more symptoms of unipolar depression, without current psychotic features (one of these symptoms should be anhedonia)
- Currently on a medication for a mood disorder
- Proficiency in English
- Able to provide informed consent
You may not qualify if:
- Current psychosis (schizoaffective, schizophreniform, delusional disorder)
- Current suicide risk sufficient to preclude treatment on an outpatient basis
- Severe, unstable concurrent psychiatric conditions likely to require hospitalization within six months (ex. hazardous substance use evidenced by a score \> 10 on the Alcohol Use Disorders Identification Test or \> 2 on the Drug Use Disorders identification Test)
- Current incarcerated or on probation due to criminal allegations
- Currently pregnant
- Cognitive impairment
- Those living in the United States on a VISA
- Those currently in psychotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jackie K Gollan, Ph.D.
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 10, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 30, 2016
Record last verified: 2016-09