Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | May 2016 |
| Contact: | Jackie K Gollan, Ph.D. |
| Email: | j-gollan@northwestern.edu |
| Phone: | 312-695-6121 |
Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder: Patient Preferences and Outcomes
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.
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.
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).
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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