Behavioral Activation – From Inpatient to Outpatient Services

Overview

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.

Full Title of Study: “Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services – A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2016

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.

Interventions

  • Behavioral: Behavioral Activation
  • Behavioral: Supportive Therapy

Arms, Groups and Cohorts

  • Experimental: Behavioral Activation
    • 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.
  • Active Comparator: Supportive Therapy
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
    • Time Frame: Weekly during treatment period of 6 weeks
    • 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)
    • Time Frame: 24 hours
  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
    • Time Frame: 6 months
  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
    • Time Frame: 12 months

Secondary Measures

  • Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    • Time Frame: 24 hours
    • 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)
    • Time Frame: 6 months
  • Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
    • Time Frame: 12 months
  • Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    • Time Frame: 24 hours
    • 10 item screening instrument for alcohol use
  • Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    • Time Frame: 6 months
    • 10 item screening instrument for alcohol use
  • Change from baseline in Alcohol Disorders Identification Test (AUDIT)
    • Time Frame: 12 months
    • 10 item screening instrument for alcohol use
  • Change from baseline in The Sheehan Disability Scale (SDS)
    • Time Frame: 24 hours
    • 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)
    • Time Frame: 6 months
  • Change from baseline in The Sheehan Disability Scale (SDS)
    • Time Frame: 12 months
  • Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    • Time Frame: 24 hours
    • 9 item self rating instrument of activation and avoidance.
  • Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    • Time Frame: Weekly druing treatment period of 6 weeks
    • 9 item self rating instrument of activation and avoidance.
  • Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    • Time Frame: 6 months
    • 9 item self rating instrument of activation and avoidance.
  • Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
    • Time Frame: 12 months
    • 9 item self rating instrument of activation and avoidance.
  • Change from baseline in sick leave and employment status
    • Time Frame: 6 months
    • 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
    • Time Frame: 12 months
  • Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
    • Time Frame: 24 hours
    • 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)
    • Time Frame: 6 months
    • 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)
    • Time Frame: 12 months
    • 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)
    • Time Frame: 24 hours
    • Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    • Time Frame: 6 months
    • Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
    • Time Frame: 12 months
    • Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
  • Change from baseline in Global Assessment of Functioning (GAF)
    • Time Frame: 24 hours
    • 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)
    • Time Frame: 6 months
    • 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)
    • Time Frame: 12 months
    • Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
  • Change from baseline in Clinical Global Impression (CGI)
    • Time Frame: 24 hours
    • 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)
    • Time Frame: 6 months
  • Change from baseline in Clinical Global Impression (CGI)
    • Time Frame: 12 months
  • Change from baseline in Usage of mental health care
    • Time Frame: 6 months
    • 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
    • Time Frame: 12 months
    • Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Uppsala University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fredrik Folke, PhD-student – Uppsala University
  • Overall Official(s)
    • Per Söderberg, PhD, Study Director, The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden
    • Lisa Ekselius, Professor, Study Chair, Department of Neuroscience, Psychiatry, Uppsala University, Sweden
    • Stefan Tungström, PhD, Study Chair, The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden
    • Timo Hursti, PhD, Study Chair, The Department of Psychology, Uppsala University, Sweden
    • Fredrik Folke, PhD-student, Principal Investigator, Department of Neuroscience, Psychiatry, Uppsala University, Sweden

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.