NCT01786733

Brief Summary

The purpose of this study is to compare the effectiveness of Behavioral Activation and Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts during inpatient care and can continue in an outpatient facility if the patients are discharged before 12 sessions has been completed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

January 29, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

January 29, 2013

Last Update Submit

May 2, 2017

Conditions

Inpatient Facility DiagnosesPsychiatric DisordersDepressive Symptoms

Keywords

Acute Inpatient PsychiatryContinuity of CareBehavioral ActivationDepression

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)

    MADRS-S is a 9 item self report measure of depressive symptoms.

    Weekly during treatment period of 6 weeks

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)

    24 hours

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)

    6 months

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)

    12 months

Secondary Outcomes (29)

  • Change from baseline in EuroQol 5 Dimension Scale (EQ5D)

    24 hours

  • Change from baseline in EuroQol 5 Dimension Scale (EQ5D)

    6 months

  • Change from baseline in EuroQol 5 Dimension Scale (EQ5D)

    12 months

  • Change from baseline in Alcohol Disorders Identification Test (AUDIT)

    24 hours

  • Change from baseline in Alcohol Disorders Identification Test (AUDIT)

    6 months

  • +24 more secondary outcomes

Study Arms (2)

Behavioral Activation

EXPERIMENTAL

Behavioral Activation + Treatment as Usual. 12 sessions twice weekly (i.e. 6 weeks). Individual therapy. Therapy is initiated during inpatient admission and continue after discharge. Protocol aimed at increased activation towards goals and personal values and decreased avoidance behaviors.

Behavioral: Behavioral Activation

Supportive Therapy

ACTIVE COMPARATOR

Supportive Therapy + Treatment as Usual. 12 sessions twice weekly (i.e. 6 weeks). Individual therapy. Therapy is initiated during inpatient admission and continue after discharge. Protocol aimed at providing psychological non-directive support.

Behavioral: Supportive Therapy

Interventions

Behavioral ActivationBEHAVIORAL
Behavioral Activation
Supportive TherapyBEHAVIORAL
Supportive Therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Admitted into one of four acute psychiatric inpatient units in Dalarna
  • MADRS-S 20 and above at acute admission and and after 2-3 days on the ward
  • Psychiatric disorder according to M.I.N.I (Sheehan et al., 1998)
  • Read and Speak Swedish

You may not qualify if:

  • Acute psychotic symptoms
  • Acute manic symptoms
  • Confusion
  • Primary eating disorder
  • Primary alcohol or substance abuse disorder
  • Self rated score on AUDIT (Saunders et al., 1993)of 20 or greater
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental DisordersDepression

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Per Söderberg, PhD

    The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden

    STUDY DIRECTOR

  • Lisa Ekselius, Professor

    Department of Neuroscience, Psychiatry, Uppsala University, Sweden

    STUDY CHAIR

  • Stefan Tungström, PhD

    The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden

    STUDY CHAIR

  • Timo Hursti, PhD

    The Department of Psychology, Uppsala University, Sweden

    STUDY CHAIR

  • Fredrik Folke, PhD-student

    Department of Neuroscience, Psychiatry, Uppsala University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 8, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2016

Study Completion

April 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05