DepressionNCT01694719
Cognitive Control Training as an Adjunct to Behavioral Activation Therapy in the Treatment of Depression
A study testing Brief Behavioral Activation Treatment for Depression in people with Depression, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the potential effects of a cognitive training program when combined with a particular form of psychotherapy (behavioral activation therapy) for depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Brief Behavioral Activation Treatment for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18-65
- Primary psychiatric diagnosis of major depressive disorder
- Ability to read and speak English sufficiently to complete study procedures
- If taking antidepressant or anxiolytic medication, participants must be taking a stabilized dose for a minimum period of at least 8 weeks prior to entry into the study
- Willingness and ability to comply with the requirements of the study protocol
Who cannot join
- Lifetime history of bipolar disorder or psychotic disorder
- Neurological disorder such as Parkinson's disease or traumatic brain injury
- Alcohol or substance dependence within the past 6 months
- Substantial suicide risk
- Concurrent psychotherapy initiated within 2 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the depression other than general supportive therapy
- Current use of antipsychotics, stimulants, or modafinil
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston University - Translational Research Program
Boston, Massachusetts, 02215
Samantha Moshier, M.A., 617-358-4311, smoshier@bu.edu
About this study
The purpose of this study is to evaluate the potential effects of a cognitive training program when combined with a particular form of psychotherapy (behavioral activation therapy) for depression. Behavioral activation therapy targets changes in behavior as a method for improving a depressed individual's thoughts, feelings, and overall quality of life. This study is designed to test whether a computerized brain exercise called cognitive control training can enhance the effects of a 5-session behavioral activation therapy program. CCT has been shown to reduce depressive symptoms in two other studies, but it has not yet been combined with behavioral activation therapy. The investigators hypothesize that individuals assigned to the behavioral activation plus cognitive control training condition will demonstrate reduced depressive symptoms from pre to post treatment compared with those assigned to the behavioral activation plus computerized control condition. The investigators hypothesize that these gains will be maintained at one-month follow up.
- Conditions
- Depression
- Being tested
- Brief Behavioral Activation Treatment for Depression, Cognitive Control Training
- Keywords
- Depression, Major Depressive Disorder, Behavioral Activation, Cognitive Training
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Activation Treatment for DepressionBehavioural
Cognitive Control TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation + Cognitive Control Training | Experimental | Participants will receive 5 sessions of behavioral activation therapy concurrent with 4 sessions of cognitive control training, a computerized intervention which targets cognitive control processes such as working memory and attention. Receives: Behavioral: Brief Behavioral Activation Treatment for Depression; Behavioral: Cognitive Control Training |
| Behavioral Activation Therapy plus Control Task | Active comparator | Participants will receive 5 sessions of behavioral activation therapy and 4 sessions of a non-active, computerized control task. Receives: Behavioral: Brief Behavioral Activation Treatment for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Secondary outcomes (1)
Montgomery Asberg Depression Rating Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Moshier, M.A., Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694719
- Sponsor's protocol ID
- 2930
- Status last verified
- Sep 2012
- First submitted
- 24 Sep 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Control Training as an Adjunct to Behavioral Activation Therapy in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT01694719
- Acronym / sponsor ID
- 2930
- Conditions
- Depression
- Keywords
- Depression, Major Depressive Disorder, Behavioral Activation, Cognitive Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 27 Sep 2012 (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 purpose of this study is to evaluate the potential effects of a cognitive training program when combined with a particular form of psychotherapy (behavioral activation therapy) for depression. Behavioral activation therapy targets changes in behavior as a method for improving a depressed individual's thoughts, feelings, and overall quality of life. This study is designed to test whether a computerized brain exercise called cognitive control training can enhance the effects of a 5-session behavioral activation therapy program. CCT has been shown to reduce depressive symptoms in two other studies, but it has not yet been combined with behavioral activation therapy. The investigators hypothesize that individuals assigned to the behavioral activation plus cognitive control training condition will demonstrate reduced depressive symptoms from pre to post treatment compared with those assigned to the behavioral activation plus computerized control condition. The investigators hypothesize that these gains will be maintained at one-month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation + Cognitive Control Training | Experimental | Behavioral: Brief Behavioral Activation Treatment for Depression, Behavioral: Cognitive Control TrainingParticipants will receive 5 sessions of behavioral activation therapy concurrent with 4 sessions of cognitive control training, a computerized intervention which targets cognitive control processes such as working memory and attention. |
| Behavioral Activation Therapy plus Control Task | Active comparator | Behavioral: Brief Behavioral Activation Treatment for DepressionParticipants will receive 5 sessions of behavioral activation therapy and 4 sessions of a non-active, computerized control task. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ages 18-65
- Primary psychiatric diagnosis of major depressive disorder
- Ability to read and speak English sufficiently to complete study procedures
- If taking antidepressant or anxiolytic medication, participants must be taking a stabilized dose for a minimum period of at least 8 weeks prior to entry into the study
- Willingness and ability to comply with the requirements of the study protocol
Key exclusion criteria (6 listed)
- Lifetime history of bipolar disorder or psychotic disorder
- Neurological disorder such as Parkinson's disease or traumatic brain injury
- Alcohol or substance dependence within the past 6 months
- Substantial suicide risk
- Concurrent psychotherapy initiated within 2 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the depression other than general supportive therapy
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 |
|---|---|---|
| Brief Behavioral Activation Treatment for Depression | Behavioural | Behavioral Activation + Cognitive Control Training, Behavioral Activation Therapy plus Control Task |
| Cognitive Control Training | Behavioural | Behavioral Activation + Cognitive Control Training |
Primary outcome
Beck Depression Inventory
1 secondary outcome
Montgomery Asberg Depression Rating Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Activation Treatment for Depression in people with Depression, run by Boston 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 5 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: status not confirmed, as of the sponsor's last update on 27 Sep 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha J Moshier, M.A. (617-358-4311, smoshier@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory. 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 27 Sep 2012; AzTrials last refreshed its copy on 27 Oct 2026.