Bipolar DisorderNCT00595387
Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder
A study testing Supportive Psychotherapy and Cognitive Behavioral Therapy (CBT) in people with Bipolar Disorder and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will compare the effectiveness of cognitive behavioral therapy versus supportive psychotherapy in decreasing depression in people with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bipolar Disorder, Depression
- What is being tested?
- Supportive Psychotherapy and Cognitive Behavioral Therapy (CBT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2013
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Normal or corrected-to-normal vision (tested by vision charts)
- Diagnosis of bipolar I disorder by the Mini International Neuropsychiatric Interview (MINI)
- HAM-D score of 17 or higher
Who cannot join
- Meets criteria for DSM-IV bipolar I disorder subtype rapid cycling
- Meets criteria for DSM-IV mixed episode
- Pregnant
- Serious medical illness
- Neurologic disorder and/or head trauma
- Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder, including organic mental disorder, schizophrenia, delusional disorder, and psychotic disorders not otherwise specified
Show all 10Show fewer
- Substance abuse or dependence within the 12 months prior to study entry and/or history of substance abuse for more than 12 months
- IQ of less than 80 on the Wechsler Adult Reading Test
- Previous treatment with CBT for depression
- Contraindications to MRI (e.g., metallic implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Bipolar Clinic and Research Program
Boston, Massachusetts, 02114
About this study
Official title: Cognitive-Behavior Therapy for Bipolar Disorder
This study will compare the effectiveness of cognitive behavioral therapy versus supportive psychotherapy in decreasing depression in people with bipolar disorder.
Read the detailed description
Bipolar I disorder (BP-I) is a chronic debilitating disorder with recurrent depressive and/or manic mood episodes. Although episodes of mania are often considered the most distinguishing feature of bipolar disorder, recurrent episodes of depression make up the most functionally debilitating aspect for many individuals with BP-I. Symptoms of depressive episodes include depressed mood, lack of interest, decreased energy, low self-esteem, trouble sleeping, and change in appetite. Mood stabilizers are usually the first line of treatment for patients with bipolar disorder who are in a depressive episode, but previous research has shown that these treatments fail to bring most patients to sustained remission. As an adjunct to medication, a psychosocial treatment known as cognitive behavioral therapy (CBT) may be a promising treatment for improving depressive symptoms and for long-term stabilization in individuals with BP-I. This study will compare the effectiveness of CBT versus supportive psychotherapy in decreasing depression in people with BP-I. Using magnetic resonance imaging (MRI), this study will also assess the impact of episodic memory impairment in people with BP-I on the success of CBT treatment.
Participation in this single-blind study will last about 9 months and will include 22 study visits. There will be four pretreatment visits, during which participants will undergo a variety of tests and procedures, including interviews and questionnaires about depression and anxiety; tests on memory, attention, reaction time, and reading; and an MRI scan. Following completion of the initial assessments, participants will be randomly assigned to receive CBT or supportive psychotherapy. Participants in both groups will attend eighteen 1-hour treatment sessions over 5 months. Participants attending CBT sessions will learn specific thought processing and behavioral exercises to help reduce depressive symptoms. Participants attending psychosocial therapy sessions will learn about signs and symptoms related to depression and will be provided support in coping with their depression.
All participants will be asked to complete Mood and Memory Questionnaires before and after the first seven treatment sessions. Psychological evaluations will occur after Visits 8 and 18 of treatment and will involve the completion of questionnaires. Participants in both groups will attend a follow-up visit to evaluate tic symptoms, anxiety, and mood 4 months after the final treatment session.
- Conditions
- Bipolar Disorder, Depression
- Being tested
- Supportive Psychotherapy, Cognitive Behavioral Therapy (CBT)
- Keywords
- Cognitive Behavioral Therapy
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive PsychotherapyOther
Participants will attend 18 supportive therapy sessions over 5 months. Supportive psychotherapy focuses on reflecting and expressing feelings about current life issues. Participants are supported and comforted when coping with difficult situations, depression, mood swings, or anger.
Cognitive Behavioral Therapy (CBT)Other
Participants will attend 18 CBT sessions over 5 months. CBT for depression targets depressive symptoms through a range of different treatments. This includes psychoeducation about the disorder and educating patients about the role of thoughts and behaviors in the maintenance of depressed mood. CBT also includes mood and activity monitoring, activity scheduling, and teaching participants to critically investigate and challenge negative thoughts and core beliefs that help to maintain depression.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants receiving supportive psychotherapy Receives: Other: Supportive Psychotherapy |
| 2 | Experimental | Participants receiving cognitive behavioral therapy Receives: Other: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D)
Measured: Measured at baseline and Weeks 9, 20, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionSep 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thilo Deckersbach, Massachusetts General Hospital
- Investigators
- Thilo Deckersbach, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595387
- Sponsor's protocol ID
- 2006P001521
- Other IDs
- K23MH074895, DSIR 83-ATP
- Status last verified
- Apr 2015
- First submitted
- 4 Jan 2008
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavior Therapy for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00595387
- Acronym / sponsor ID
- 2006P001521
- Conditions
- Bipolar Disorder, Depression
- Keywords
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Jan 2008 (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.
This study will compare the effectiveness of cognitive behavioral therapy versus supportive psychotherapy in decreasing depression in people with bipolar disorder.
Detailed description
Bipolar I disorder (BP-I) is a chronic debilitating disorder with recurrent depressive and/or manic mood episodes. Although episodes of mania are often considered the most distinguishing feature of bipolar disorder, recurrent episodes of depression make up the most functionally debilitating aspect for many individuals with BP-I. Symptoms of depressive episodes include depressed mood, lack of interest, decreased energy, low self-esteem, trouble sleeping, and change in appetite. Mood stabilizers are usually the first line of treatment for patients with bipolar disorder who are in a depressive episode, but previous research has shown that these treatments fail to bring most patients to sustained remission. As an adjunct to medication, a psychosocial treatment known as cognitive behavioral therapy (CBT) may be a promising treatment for improving depressive symptoms and for long-term stabilization in individuals with BP-I. This study will compare the effectiveness of CBT versus supportive psychotherapy in decreasing depression in people with BP-I. Using magnetic resonance imaging (MRI), this study will also assess the impact of episodic memory impairment in people with BP-I on the success of CBT treatment.
Participation in this single-blind study will last about 9 months and will include 22 study visits. There will be four pretreatment visits, during which participants will undergo a variety of tests and procedures, including interviews and questionnaires about depression and anxiety; tests on memory, attention, reaction time, and reading; and an MRI scan. Following completion of the initial assessments, participants will be randomly assigned to receive CBT or supportive psychotherapy. Participants in both groups will attend eighteen 1-hour treatment sessions over 5 months. Participants attending CBT sessions will learn specific thought processing and behavioral exercises to help reduce depressive symptoms. Participants attending psychosocial therapy sessions will learn about signs and symptoms related to depression and will be provided support in coping with their depression.
All participants will be asked to complete Mood and Memory Questionnaires before and after the first seven treatment sessions. Psychological evaluations will occur after Visits 8 and 18 of treatment and will involve the completion of questionnaires. Participants in both groups will attend a follow-up visit to evaluate tic symptoms, anxiety, and mood 4 months after the final treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Supportive PsychotherapyParticipants receiving supportive psychotherapy |
| 2 | Experimental | Other: Cognitive Behavioral Therapy (CBT)Participants receiving cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal or corrected-to-normal vision (tested by vision charts)
- Diagnosis of bipolar I disorder by the Mini International Neuropsychiatric Interview (MINI)
- HAM-D score of 17 or higher
Key exclusion criteria (10 listed)
- Meets criteria for DSM-IV bipolar I disorder subtype rapid cycling
- Meets criteria for DSM-IV mixed episode
- Pregnant
- Serious medical illness
- Neurologic disorder and/or head trauma
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 |
|---|---|---|
| Supportive PsychotherapyParticipants will attend 18 supportive therapy sessions over 5 months. Supportive psychotherapy focuses on reflecting and expressing feelings about current life issues. Participants are supported and comforted when coping with difficult situations, depression, mood swings, or anger. | Other | 1 |
| Cognitive Behavioral Therapy (CBT)Participants will attend 18 CBT sessions over 5 months. CBT for depression targets depressive symptoms through a range of different treatments. This includes psychoeducation about the disorder and educating patients about the role of thoughts and behaviors in the maintenance of depressed mood. CBT also includes mood and activity monitoring, activity scheduling, and teaching participants to critically investigate and challenge negative thoughts and core beliefs that help to maintain depression. | Other | 2 |
Primary outcome
Hamilton Depression Rating Scale (HAM-D)
Time frame: Measured at baseline and Weeks 9, 20, and 36
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 29 Apr 2015.
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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.
Thilo Deckersbach, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Psychotherapy and Cognitive Behavioral Therapy (CBT) in people with Bipolar Disorder and Depression, run by Massachusetts General Hospital 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 3 inclusion and 10 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 29 Apr 2015. 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?
Hamilton Depression Rating Scale (HAM-D) (time frame: Measured at baseline and Weeks 9, 20, and 36). 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 29 Apr 2015.