Bipolar DisorderPhase 1NCT01176825
Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder
A Phase 1 study testing cognitive-behavior therapy (CBT) in people with Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- cognitive-behavior therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2011
- Phase
- Phase 1
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of bipolar spectrum disorder (Bipolar I, Bipolar II, or Bipolar NOS Disorder)
- ages 18-24 years
- able to understand the nature of the study as well as potential risks and benefits
- in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed.
Who cannot join
- concurrent cognitive-behavioral psychotherapy
- documented mental retardation
- pervasive developmental disorder
- current serious medical illness
- inability to participate in the intervention because of acuity of symptoms
- current drug or alcohol dependence (other than marijuana dependence)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood
The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. The intervention also focuses on issues specific to transition-age youth. The study includes two phases: In phase 1, the intervention will be developed, refined, and openly piloted with several participants. In phase 2,the investigators will conduct a randomized clinical trial, in which 40 participants will be randomized either to receive the intervention right away, or to a 14-week waitlist condition. Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period, as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors, drug and alcohol use, and psychosocial functioning.
- Conditions
- Bipolar Disorder
- Being tested
- cognitive-behavior therapy (CBT)
- Keywords
- bipolar disorder, cognitive behavior therapy, alcohol abuse, drug abuse, high risk behaviors, medication adherence, psychosocial functioning
- Medical subject headings
- Bipolar Disorder, Alcoholism, Substance-Related Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavior therapy (CBT)Behavioural
14 sessions of individual cognitive-behavior therapy. Sessions last 50-60 minutes and are held weekly. 2 optional monthly booster sessions may also be held after the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | 14-week individual cognitive-behavior therapy Receives: Behavioral: cognitive-behavior therapy (CBT) |
| Treatment As Usual | No intervention | 14-week waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Improvement Scale (CGI)-Improvement
Clinician-rated change in mood symptoms and overall functioning
Measured: week 5, week 10, week 14, 3 mo fu, 6 mo fu
feasibility and acceptability
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
Measured: post-treatment
Secondary outcomes (16)
Adapted Y-BOCS
a version of the Yale-Brown Obsessive-Compulsive Scale that has been adapted to assess involvement in high-risk behaviors. This measure is individualized for each participant to assess their specific high-risk behavior that they would like to work on in treatment
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Social Adjustment Scale (SAS)
Assesses social, educational, occupational, and family functioning
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Timeline Follow-Back
Assesses alcohol and drug use over the past 30 days.
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
SCID depression and mania modules
Clinician-administered measure that assesses the presence and severity of depression and mania over the past month.
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Medication history and adherence
Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization
Measured: baseline, post-treatment, 6 month follow-up
Adult Suicidal Ideation Questionnaire (ASIQ)
Assesses severity of suicidal thoughts and behaviors
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
High-Risk Sexual Behaviors
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Beck Hopelessness Scale
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Barratt Impulsiveness Scale
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Self-Control Behavior Schedule
Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Hamilton Depression Scale (HAM-D)
Clinician-administered measure that assesses severity of depressive symptoms over the past week
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Young Mania Rating Scale
Clinician-administered measure that assesses severity of manic symptoms over the past week.
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Treatment Satisfaction Questionnaire
Assesses participants' satisfaction with the treatment received
Measured: post-treatment
Urine Toxicology Screen
Measured: baseline, post-treatment, 6 mo follow-up
Risky Driving Inventory
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
South Oaks Gambling Screen
Measured: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionNov 2011
- Study completionNov 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 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, Aude Henin, Massachusetts General Hospital
- Investigators
- Aude Henin, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176825
- Sponsor's protocol ID
- R34MH081335
- Other IDs
- R34MH081335
- Status last verified
- Apr 2012
- First submitted
- 5 Aug 2010
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood
- ClinicalTrials.gov ID
- NCT01176825
- Acronym / sponsor ID
- R34MH081335
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, cognitive behavior therapy, alcohol abuse, drug abuse, high risk behaviors, medication adherence, psychosocial functioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Aug 2010 (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.
The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. The intervention also focuses on issues specific to transition-age youth. The study includes two phases: In phase 1, the intervention will be developed, refined, and openly piloted with several participants. In phase 2,the investigators will conduct a randomized clinical trial, in which 40 participants will be randomized either to receive the intervention right away, or to a 14-week waitlist condition. Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period, as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors, drug and alcohol use, and psychosocial functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: cognitive-behavior therapy (CBT)14-week individual cognitive-behavior therapy |
| Treatment As Usual | No intervention | –14-week waitlist control |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of bipolar spectrum disorder (Bipolar I, Bipolar II, or Bipolar NOS Disorder)
- ages 18-24 years
- able to understand the nature of the study as well as potential risks and benefits
- in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed.
Key exclusion criteria (6 listed)
- concurrent cognitive-behavioral psychotherapy
- documented mental retardation
- pervasive developmental disorder
- current serious medical illness
- inability to participate in the intervention because of acuity of symptoms
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 |
|---|---|---|
| cognitive-behavior therapy (CBT)14 sessions of individual cognitive-behavior therapy. Sessions last 50-60 minutes and are held weekly. 2 optional monthly booster sessions may also be held after the end of treatment. | Behavioural | CBT |
Primary outcome
Clinical Global Improvement Scale (CGI)-Improvement
Time frame: week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-rated change in mood symptoms and overall functioning
feasibility and acceptability
Time frame: post-treatment
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
16 secondary outcomes
Adapted Y-BOCS
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Social Adjustment Scale (SAS)
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Timeline Follow-Back
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
SCID depression and mania modules
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Medication history and adherence
Time frame: baseline, post-treatment, 6 month follow-up
Adult Suicidal Ideation Questionnaire (ASIQ)
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
High-Risk Sexual Behaviors
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Beck Hopelessness Scale
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Barratt Impulsiveness Scale
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Self-Control Behavior Schedule
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Hamilton Depression Scale (HAM-D)
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Young Mania Rating Scale
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Treatment Satisfaction Questionnaire
Time frame: post-treatment
Urine Toxicology Screen
Time frame: baseline, post-treatment, 6 mo follow-up
Risky Driving Inventory
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
South Oaks Gambling Screen
Time frame: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
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 26 Apr 2012.
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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.
Aude Henin, Ph.D. 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 Phase 1 study testing cognitive-behavior therapy (CBT) in people with Bipolar Disorder, 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 4 inclusion and 6 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 26 Apr 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical Global Improvement Scale (CGI)-Improvement (time frame: week 5, week 10, week 14, 3 mo fu, 6 mo fu). The study lists 2 primary outcomes in all. 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 26 Apr 2012.