Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 6:42 PM
Study NCT ID:
NCT02494050
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder: Patient Preferences and Outcomes
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: