DepressionNCT02494050
Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder
A study testing Behavioral Activation-Full, Behavioral Activation-Short and Bipolar Disorder Collaborative Care in people with Depression and Bipolar Disorder, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Depression, Bipolar Disorder, Anhedonia
- What is being tested?
- Behavioral Activation-Full, Behavioral Activation-Short and Bipolar Disorder Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Depression, Bipolar Disorder, Anhedonia
- Being tested
- Behavioral Activation-Full, Behavioral Activation-Short, Bipolar Disorder Collaborative Care
- Keywords
- Depression, Bipolar Disorder, Anhedonia, Women
- Medical subject headings
- Depression, Bipolar Disorder, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation-FullBehavioural
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-ShortBehavioural
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.
Bipolar Disorder Collaborative CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation-Full | Experimental | Twelve weekly sessions of phone therapy using Behavioral Activation Treatment for Anhedonia. Receives: Behavioral: Behavioral Activation-Full |
| Behavioral Activation-Short | Experimental | Eight weekly sessions of phone therapy using Behavioral Activation Treatment for Anhedonia. Receives: Behavioral: Behavioral Activation-Short |
| Bipolar Disorder Collaborative Care | Active comparator | Twelve weekly sessions of phone therapy using BDCC manual adapted for anhedonia. Receives: Behavioral: Bipolar Disorder Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snaith-Hamilton Pleasure Scale-Clinician Version
Clinician-administered measure of anhedonia spanning the domains of: interests, social interaction, sensory experience, and food/drink.
Measured: approximately 12-14 weeks after enrolling into the treatment
Secondary outcomes (2)
Inventory of Depressive Symptomatology-Clinician
Clinician-administered measure of depression severity
Measured: approximately 12-14 weeks after enrolling into the treatment
Clinician-Administered Rating Scale for Mania
Clinician-administered measure of the severity of manic symptoms which includes items that focus on Bipolar and items that focus on psychosis
Measured: approximately 12-14 weeks after enrolling into the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Gollan, Northwestern University
- Investigators
- Jackie K Gollan, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494050
- Sponsor's protocol ID
- STU00200085
- Status last verified
- Sep 2016
- First submitted
- 30 Jun 2015
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Women With Anhedonia in Bipolar and Unipolar Disorder: Patient Preferences and Outcomes
- ClinicalTrials.gov ID
- NCT02494050
- Acronym / sponsor ID
- STU00200085
- Conditions
- Depression, Bipolar Disorder, Anhedonia
- Keywords
- Depression, Bipolar Disorder, Anhedonia, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation-Full | Experimental | Behavioral: Behavioral Activation-FullTwelve weekly sessions of phone therapy using Behavioral Activation Treatment for Anhedonia. |
| Behavioral Activation-Short | Experimental | Behavioral: Behavioral Activation-ShortEight weekly sessions of phone therapy using Behavioral Activation Treatment for Anhedonia. |
| Bipolar Disorder Collaborative Care | Active comparator | Behavioral: Bipolar Disorder Collaborative CareTwelve weekly sessions of phone therapy using BDCC manual adapted for anhedonia. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation-FullBehavioral 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. | Behavioural | Behavioral Activation-Full |
| Behavioral Activation-ShortBehavioral 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. | Behavioural | Behavioral Activation-Short |
| Bipolar Disorder Collaborative CareThis 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. | Behavioural | Bipolar Disorder Collaborative Care |
Primary outcome
Snaith-Hamilton Pleasure Scale-Clinician Version
Time frame: approximately 12-14 weeks after enrolling into the treatment
Clinician-administered measure of anhedonia spanning the domains of: interests, social interaction, sensory experience, and food/drink.
2 secondary outcomes
Inventory of Depressive Symptomatology-Clinician
Time frame: approximately 12-14 weeks after enrolling into the treatment
Clinician-Administered Rating Scale for Mania
Time frame: approximately 12-14 weeks after enrolling into the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie K Gollan, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation-Full, Behavioral Activation-Short and Bipolar Disorder Collaborative Care in people with Depression and Bipolar Disorder, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snaith-Hamilton Pleasure Scale-Clinician Version (time frame: approximately 12-14 weeks after enrolling into the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.