NCT02712918

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

March 9, 2015

Last Update Submit

March 15, 2016

Conditions

Depression

Keywords

DepressionInpatientAcuteBrief Behavioral Activation Treatment for Depression

Outcome Measures

Primary Outcomes (1)

  • Change of Beck's Depression Inventory-II from baseline

    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

    Second day of admission. After first sessions of BATD.

  • Treatment Evaluation Inventory - Short Form

    Prior to discharge from the ward (maximum 21 days, expected average of 10 days)..

Study Arms (2)

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.

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.

Other: Standard Care

Interventions

Brief Behavioral Activation Treatment for DepressionBEHAVIORAL

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.

Brief Behavioral Activation Treatment for Depression
Standard CareOTHER

Treatment as usual at the ward

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe depression (BDI-II \> 28 Points).
  • Admission length of at least 3 days
  • Evaluated to benefit from depression treatment by unit psychiatrist.

You may not qualify if:

  • Current psychotic disorder
  • Previously diagnosis with psychotic disorder (including Bipolar disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 11317637BACKGROUND

  • 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.

    PMID: 21324944BACKGROUND

  • 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.

    PMID: 12971122RESULT

MeSH Terms

Conditions

Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Learning Disability Nurse/MSc Behavior Analysis

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 18, 2016

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 18, 2016

Record last verified: 2016-03