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Brief Behavioral Activation Treatment for Depression With Inpatients

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief Behavioral Activation Treatment for Depression
Standard Care
Sponsored by
Lovisenberg Diakonale Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Inpatient, Acute, Brief Behavioral Activation Treatment for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Brief Behavioral Activation Treatment for Depression

    Standard care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change of Beck's Depression Inventory-II from baseline

    Secondary Outcome Measures

    Credibility and Expectancies Questionnaire
    Only BATD group
    Treatment Evaluation Inventory - Short Form
    Only BATD group

    Full Information

    First Posted
    March 9, 2015
    Last Updated
    March 15, 2016
    Sponsor
    Lovisenberg Diakonale Hospital
    Collaborators
    Oslo Metropolitan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02712918
    Brief Title
    Brief Behavioral Activation Treatment for Depression With Inpatients
    Official Title
    An Evaluation of Brief Behavioral Activation Treatment for Depression With Moderate to Severely Depressed Inpatients - A Small Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lovisenberg Diakonale Hospital
    Collaborators
    Oslo Metropolitan University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Depression, Inpatient, Acute, Brief Behavioral Activation Treatment for Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brief Behavioral Activation Treatment for Depression
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard care
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Brief Behavioral Activation Treatment for Depression
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Care
    Intervention Description
    Treatment as usual at the ward
    Primary Outcome Measure Information:
    Title
    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).
    Secondary Outcome Measure Information:
    Title
    Credibility and Expectancies Questionnaire
    Description
    Only BATD group
    Time Frame
    Second day of admission. After first sessions of BATD.
    Title
    Treatment Evaluation Inventory - Short Form
    Description
    Only BATD group
    Time Frame
    Prior to discharge from the ward (maximum 21 days, expected average of 10 days)..

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11317637
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21324944
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12971122
    Citation
    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.
    Results Reference
    result

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    Brief Behavioral Activation Treatment for Depression With Inpatients

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