DepressionNCT02712918
Brief Behavioral Activation Treatment for Depression With Inpatients
A study testing Brief Behavioral Activation Treatment for Depression in people with Depression, run by Lovisenberg Diakonale Hospital.
Trial summary
The purpose of the current study was to examine Brief Behavioral Activation Treatment for Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly depressed inpatients. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe depression (BDI-II > 28 Points).
- Admission length of at least 3 days
- Evaluated to benefit from depression treatment by unit psychiatrist.
Who cannot join
- Current psychotic disorder
- Previously diagnosis with psychotic disorder (including Bipolar disorder)
About this study
Official title: An Evaluation of Brief Behavioral Activation Treatment for Depression With Moderate to Severely Depressed Inpatients - A Small Randomized Controlled Trial
The purpose of the current study was to examine Brief Behavioral Activation Treatment for Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly depressed inpatients. The study is a systematic replication of a randomized controlled trail from 2003, that provided initial support for BATD With inpatients. The current study compared BATD to Treatment as Usual in a randomized controlled trial.
- Conditions
- Depression
- Being tested
- Brief Behavioral Activation Treatment for Depression, Standard Care
- Keywords
- Depression, Inpatient, Acute, Brief Behavioral Activation Treatment for Depression
- Medical subject headings
- Depression
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
Behavioral treatment of depression which focuses on increasing the Level of positive reinforcement through systematic and goal directed activation of behavior. Goal and values are assessed and used to determine target behaviors.
Standard CareOther
Treatment as usual at the ward
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Activation Treatment for Depression | Experimental | Behavioral treatment of depression. The study utilized the revised version of the Brief Behavioral Activation Treatment for Depression (BATD) protocol from 2011. The treatment was added to treatment as usual. Up to 10 sessions were administered. Receives: Behavioral: Brief Behavioral Activation Treatment for Depression |
| Standard care | Placebo comparator | Standard CARE (SC) at the inpatient unit. Mandatory: Therapeutic conversations with psychiatrist, psychologist or M.D, milieu therapy. Optional: Psychosomatic physiotherapy, therapeutic groups, psychopharmacological treatment. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Beck's Depression Inventory-II from baseline
Measured: Change from baseline (second day of admission) to discharge from the ward (maximum 21 days, expected average of 10 days).
Secondary outcomes (2)
Credibility and Expectancies Questionnaire
Only BATD group
Measured: Second day of admission. After first sessions of BATD.
Treatment Evaluation Inventory - Short Form
Only BATD group
Measured: Prior to discharge from the ward (maximum 21 days, expected average of 10 days)..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Metropolitan University
- Responsible party
- Principal investigator, Martin Myhre, Lovisenberg Diakonale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712918
- Sponsor's protocol ID
- BATD_16674
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2015
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lejuez CW, Hopko DR, Hopko SD. A brief behavioral activation treatment for depression. Treatment manual. Behav Modif. 2001 Apr;25(2):255-86. doi: 10.1177/0145445501252005.
PubMed 11317637Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
PubMed 21324944Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69. doi: 10.1177/0145445503255489.
PubMed 12971122
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Brief Behavioral Activation Treatment for Depression With Moderate to Severely Depressed Inpatients - A Small Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02712918
- Acronym / sponsor ID
- BATD_16674
- Conditions
- Depression
- Keywords
- Depression, Inpatient, Acute, Brief Behavioral Activation Treatment for Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Oslo Metropolitan University
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Mar 2016 (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 the current study was to examine Brief Behavioral Activation Treatment for Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly depressed inpatients. The study is a systematic replication of a randomized controlled trail from 2003, that provided initial support for BATD With inpatients. The current study compared BATD to Treatment as Usual in a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Activation Treatment for Depression | Experimental | Behavioral: Brief Behavioral Activation Treatment for DepressionBehavioral treatment of depression. The study utilized the revised version of the Brief Behavioral Activation Treatment for Depression (BATD) protocol from 2011. The treatment was added to treatment as usual. Up to 10 sessions were administered. |
| Standard care | Placebo comparator | Other: Standard CareStandard CARE (SC) at the inpatient unit. Mandatory: Therapeutic conversations with psychiatrist, psychologist or M.D, milieu therapy. Optional: Psychosomatic physiotherapy, therapeutic groups, psychopharmacological treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe depression (BDI-II > 28 Points).
- Admission length of at least 3 days
- Evaluated to benefit from depression treatment by unit psychiatrist.
Key exclusion criteria (2 listed)
- Current psychotic disorder
- Previously diagnosis with psychotic disorder (including Bipolar disorder)
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 DepressionBehavioral treatment of depression which focuses on increasing the Level of positive reinforcement through systematic and goal directed activation of behavior. Goal and values are assessed and used to determine target behaviors. | Behavioural | Brief Behavioral Activation Treatment for Depression |
| Standard CareTreatment as usual at the ward | Other | Standard care |
Primary outcome
Change of Beck's Depression Inventory-II from baseline
Time frame: Change from baseline (second day of admission) to discharge from the ward (maximum 21 days, expected average of 10 days).
2 secondary outcomes
Credibility and Expectancies Questionnaire
Time frame: Second day of admission. After first sessions of BATD.
Treatment Evaluation Inventory - Short Form
Time frame: Prior to discharge from the ward (maximum 21 days, expected average of 10 days)..
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 18 Mar 2016.
- Background: PubMed 11317637Lejuez CW, Hopko DR, Hopko SD. A brief behavioral activation treatment for depression. Treatment manual. Behav Modif. 2001 Apr;25(2):255-86. doi: 10.1177/0145445501252005.
- Background: PubMed 21324944Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
- Results publication: PubMed 12971122Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69. doi: 10.1177/0145445503255489.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lovisenberg Diakonale Hospital.
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 2 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 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change of Beck's Depression Inventory-II from baseline (time frame: Change from baseline (second day of admission) to discharge from the ward (maximum 21 days, expected average of 10 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712918, which also lists 3 linked publications.
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 18 Mar 2016.