Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder
Condition: Depression; Bipolar Disorder; Anhedonia
MeSH terms: Anhedonia; Depression; Bipolar Disorder
Study type: Interventional

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.
    

Detailed description: 
      Prospective volunteers will be screened by phone and, if eligible, invited to a clinical
      evaluation in the laboratory, located at Northwestern University. At the laboratory,
      prospective volunteers complete written informed consent and learn about the study.

      All evaluations will measure the following variables: Anhedonia will be assessed using the
      Snaith-Hamilton Pleasure Scale, Temporal Experience of Pleasure Scale, and Effort-Expenditure
      for Rewards Task; Mood symptoms will be assessed by the Structured Clinical Interview for
      DSM-IV, Inventory of Depressive Symptomatology-Clinician Version, Clinician-Administered
      Rating Scale for Mania, Inventory of Depressive Symptomatology-Clinician version, and
      Columbia Suicide Severity Rating Scale. Treatment preferences will measured with the Stated
      Preferences Inventory for Bipolar Disorder. The presence of side effects from medications
      will be evaluated using the Frequency, Intensity, and Burden of Side Effects measure.
      Maternal function will be evaluated using the Barkin Index of Maternal Function self-report.
      Behavioral Inhibition System/Behavioral Activation System and the Behavioral Activation for
      Depression Scale are used to evaluate activation levels. Reward processing will be measured
      using the Monetary Incentive Delay Task on the computer and the Reward Probability Index
      questionnaire.

      Enrollment is determined on a set of criteria, whereby participants will be randomized into
      one of three treatment groups using a computerized randomized number generator using a 1:1:1
      ratio. Allocation concealment will be set up so the person enrolling the participant will not
      know in advance which treatment the participant will receive. Moreover, evaluators will
      remain blind to treatment assignment. Participants are randomized to receive one of three
      treatments: 12 weeks of BA, 8 weeks of BA with option to add 4 weeks, and 12 weeks of BDCC.
      Participants are asked to participate in two follow-up evaluations at the laboratory,
      scheduled at Weeks 8 and 12. The study ends after the Week 12 evaluation (approximately 12-14
      weeks after enrolling into the treatment).
    

Intervention name(s): Behavioral Activation-Full; Behavioral Activation-Short; Bipolar Disorder Collaborative Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Bipolar Disorder; Anhedonia; Women