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Brief Behavioral Activation Treatment for Depression With Inpatients

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ClinicalTrials.gov Identifier: NCT02712918
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : March 18, 2016
Sponsor:
Collaborator:
Oslo and Akershus University College of Applied Sciences
Information provided by (Responsible Party):
Martin Myhre, Lovisenberg Diakonale Hospital

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE March 18, 2016
Last Update Posted Date March 18, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
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). ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Credibility and Expectancies Questionnaire [ Time Frame: Second day of admission. After first sessions of BATD. ]
    Only BATD group
  • Treatment Evaluation Inventory - Short Form [ Time Frame: Prior to discharge from the ward (maximum 21 days, expected average of 10 days).. ]
    Only BATD group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Behavioral Activation Treatment for Depression With Inpatients
Official Title  ICMJE An Evaluation of Brief Behavioral Activation Treatment for Depression With Moderate to Severely Depressed Inpatients - A Small Randomized Controlled Trial
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Behavioral: Brief Behavioral Activation Treatment for Depression
    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.
  • Other: Standard Care
    Treatment as usual at the ward
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Brief Behavioral Activation Treatment for Depression
  • 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.
    Intervention: Other: Standard Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02712918
Other Study ID Numbers  ICMJE BATD_16674
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Myhre, Lovisenberg Diakonale Hospital
Study Sponsor  ICMJE Lovisenberg Diakonale Hospital
Collaborators  ICMJE Oslo and Akershus University College of Applied Sciences
Investigators  ICMJE Not Provided
PRS Account Lovisenberg Diakonale Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP