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Behavioral Activation - From Inpatient to Outpatient Services

Primary Purpose

Inpatient Facility Diagnoses, Psychiatric Disorders, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral Activation
Supportive Therapy
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inpatient Facility Diagnoses focused on measuring Acute Inpatient Psychiatry, Continuity of Care, Behavioral Activation, Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Behavioral Activation

    Supportive Therapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    The EQ5D is a self rating measure for health-related quality of life. It consists of 5 health state dimensions (mobility, self-care, usual activity, pain/discomfort and anxiety/depression) on which the respondent has to indicate his own health state.
    Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    10 item screening instrument for alcohol use
    Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    10 item screening instrument for alcohol use
    Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    10 item screening instrument for alcohol use
    Change from baseline in The Sheehan Disability Scale (SDS)
    The SDS is a three-item, self-report scale used to assess functioning in three areas of life (work, social life, and family life). Each item is rated on an 11-point Likert-type scale ranging from zero (no impairment) to 10 (extreme impairment), while the total range extends from zero to 30 points.
    Change from baseline in The Sheehan Disability Scale (SDS)
    Change from baseline in The Sheehan Disability Scale (SDS)
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    9 item self rating instrument of activation and avoidance.
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    9 item self rating instrument of activation and avoidance.
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    9 item self rating instrument of activation and avoidance.
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    9 item self rating instrument of activation and avoidance.
    Change from baseline in sick leave and employment status
    Interview questions regarding Days on/type of/level of sick leave Interview questions regarding employment status and hours of work per week
    Change from baseline in sick leave and employment status
    Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose psychiatric disorders in accordance with the Diagnostic and Statistical Manual (DSM-IV) and International Classification of Diseases (ICD-10).
    Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.
    Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.
    Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
    Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
    Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
    Change from baseline in Global Assessment of Functioning (GAF)
    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
    Change from baseline in Global Assessment of Functioning (GAF)
    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
    Change from baseline in Global Assessment of Functioning (GAF)
    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
    Change from baseline in Clinical Global Impression (CGI)
    Clinician rates patients' psychiatric problems in regards to severity on a scale from 0-6. After treatment the clinician rates the degree of change in relation to the first assessment.
    Change from baseline in Clinical Global Impression (CGI)
    Change from baseline in Clinical Global Impression (CGI)
    Change from baseline in Usage of mental health care
    Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.
    Change from baseline in Usage of mental health care
    Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.

    Full Information

    First Posted
    January 29, 2013
    Last Updated
    May 2, 2017
    Sponsor
    Uppsala University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01786733
    Brief Title
    Behavioral Activation - From Inpatient to Outpatient Services
    Official Title
    Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services - A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Uppsala University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Psychiatric inpatient care is reserved for individuals with the most acute mental health problems. The period after discharge is associated with increased risk for relapse, non-adherence and suicide. Delivering high quality psychosocial interventions during and after acute psychiatric inpatient care is known to be a difficult challenge. This study will investigate the effectiveness of adding either Behavioral Activation or Supportive Therapy to the standard acute psychiatric inpatient care. Subjects with different psychiatric diagnoses and elevated depressive symptoms are assessed and randomized after admission. Therapists from the nearest outpatient facility initiate 12 sessions of Behavioral Activation or Supportive Therapy as soon as possible. The 12 sessions are delivered twice weekly at the inpatient unit or at the outpatient facility, depending on whether the patient is admitted or discharged. Treatment as usual interventions(medications, nursing etc.) are not manipulated in the study. The main assessment points are pre-, post, 6 months follow-up and 12 months follow-up. The main outcome measure and some process measures are also administered at session 3, 6 and 9.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inpatient Facility Diagnoses, Psychiatric Disorders, Depressive Symptoms
    Keywords
    Acute Inpatient Psychiatry, Continuity of Care, Behavioral Activation, Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Behavioral Activation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Supportive Therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioral Activation
    Intervention Type
    Behavioral
    Intervention Name(s)
    Supportive Therapy
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
    Description
    MADRS-S is a 9 item self report measure of depressive symptoms.
    Time Frame
    Weekly during treatment period of 6 weeks
    Title
    Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
    Time Frame
    24 hours
    Title
    Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
    Time Frame
    6 months
    Title
    Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    Description
    The EQ5D is a self rating measure for health-related quality of life. It consists of 5 health state dimensions (mobility, self-care, usual activity, pain/discomfort and anxiety/depression) on which the respondent has to indicate his own health state.
    Time Frame
    24 hours
    Title
    Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    Time Frame
    6 months
    Title
    Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    Time Frame
    12 months
    Title
    Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    Description
    10 item screening instrument for alcohol use
    Time Frame
    24 hours
    Title
    Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    Description
    10 item screening instrument for alcohol use
    Time Frame
    6 months
    Title
    Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    Description
    10 item screening instrument for alcohol use
    Time Frame
    12 months
    Title
    Change from baseline in The Sheehan Disability Scale (SDS)
    Description
    The SDS is a three-item, self-report scale used to assess functioning in three areas of life (work, social life, and family life). Each item is rated on an 11-point Likert-type scale ranging from zero (no impairment) to 10 (extreme impairment), while the total range extends from zero to 30 points.
    Time Frame
    24 hours
    Title
    Change from baseline in The Sheehan Disability Scale (SDS)
    Time Frame
    6 months
    Title
    Change from baseline in The Sheehan Disability Scale (SDS)
    Time Frame
    12 months
    Title
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    Description
    9 item self rating instrument of activation and avoidance.
    Time Frame
    24 hours
    Title
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    Description
    9 item self rating instrument of activation and avoidance.
    Time Frame
    Weekly druing treatment period of 6 weeks
    Title
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    Description
    9 item self rating instrument of activation and avoidance.
    Time Frame
    6 months
    Title
    Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    Description
    9 item self rating instrument of activation and avoidance.
    Time Frame
    12 months
    Title
    Change from baseline in sick leave and employment status
    Description
    Interview questions regarding Days on/type of/level of sick leave Interview questions regarding employment status and hours of work per week
    Time Frame
    6 months
    Title
    Change from baseline in sick leave and employment status
    Time Frame
    12 months
    Title
    Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
    Description
    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose psychiatric disorders in accordance with the Diagnostic and Statistical Manual (DSM-IV) and International Classification of Diseases (ICD-10).
    Time Frame
    24 hours
    Title
    Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
    Description
    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.
    Time Frame
    6 months
    Title
    Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
    Description
    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.
    Time Frame
    12 months
    Title
    Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    Description
    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
    Time Frame
    24 hours
    Title
    Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    Description
    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
    Time Frame
    6 months
    Title
    Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    Description
    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
    Time Frame
    12 months
    Title
    Change from baseline in Global Assessment of Functioning (GAF)
    Description
    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
    Time Frame
    24 hours
    Title
    Change from baseline in Global Assessment of Functioning (GAF)
    Description
    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
    Time Frame
    6 months
    Title
    Change from baseline in Global Assessment of Functioning (GAF)
    Description
    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
    Time Frame
    12 months
    Title
    Change from baseline in Clinical Global Impression (CGI)
    Description
    Clinician rates patients' psychiatric problems in regards to severity on a scale from 0-6. After treatment the clinician rates the degree of change in relation to the first assessment.
    Time Frame
    24 hours
    Title
    Change from baseline in Clinical Global Impression (CGI)
    Time Frame
    6 months
    Title
    Change from baseline in Clinical Global Impression (CGI)
    Time Frame
    12 months
    Title
    Change from baseline in Usage of mental health care
    Description
    Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.
    Time Frame
    6 months
    Title
    Change from baseline in Usage of mental health care
    Description
    Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Per Söderberg, PhD
    Organizational Affiliation
    The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Lisa Ekselius, Professor
    Organizational Affiliation
    Department of Neuroscience, Psychiatry, Uppsala University, Sweden
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Stefan Tungström, PhD
    Organizational Affiliation
    The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Timo Hursti, PhD
    Organizational Affiliation
    The Department of Psychology, Uppsala University, Sweden
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Fredrik Folke, PhD-student
    Organizational Affiliation
    Department of Neuroscience, Psychiatry, Uppsala University, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Behavioral Activation - From Inpatient to Outpatient Services

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