- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02712918
Brief Behavioral Activation Treatment for Depression With Inpatients
March 15, 2016 updated by: Martin Myhre, Lovisenberg Diakonale Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Moderate to severe depression (BDI-II > 28 Points).
- Admission length of at least 3 days
- Evaluated to benefit from depression treatment by unit psychiatrist.
Exclusion Criteria:
- Current psychotic disorder
- Previously diagnosis with psychotic disorder (including Bipolar disorder)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Behavioral Activation Treatment for Depression
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.
|
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.
|
Placebo Comparator: Standard care
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.
|
Treatment as usual at the ward
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
|
Change from baseline (second day of admission) to discharge from the ward (maximum 21 days, expected average of 10 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Credibility and Expectancies Questionnaire
Time Frame: Second day of admission. After first sessions of BATD.
|
Only BATD group
|
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)..
|
Only BATD group
|
Prior to discharge from the ward (maximum 21 days, expected average of 10 days)..
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lejuez 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.
- 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.
- Hopko 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 15, 2016
First Posted (Estimate)
March 18, 2016
Study Record Updates
Last Update Posted (Estimate)
March 18, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BATD_16674
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Lawson Health Research InstituteTerminated
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Brief Behavioral Activation Treatment for Depression
-
University of North Carolina, Chapel HillCompleted
-
Boston UniversityUnknown
-
University of Maryland, College ParkCompletedDepressionUnited States
-
The University of Texas Health Science Center,...Completed
-
Mount Sinai Hospital, CanadaHarvard Medical School (HMS and HSDM); Patient-Centered Outcomes Research Institute and other collaboratorsActive, not recruitingPerinatal DepressionUnited States, Canada
-
Hennepin Healthcare Research InstituteCompleted
-
Dartmouth-Hitchcock Medical CenterRecruiting
-
Pontificia Universidad Catolica de ChileUnknown
-
University of Texas at AustinRecruiting
-
University of Mississippi Medical CenterTerminatedDepression | Asthma | UrticariaUnited States