Behavioral Activation - From Inpatient to Outpatient Services

Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services - A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Inpatient Facility Diagnoses; Psychiatric Disorders
• Intervention / Treatment: Behavioral: Supportive Therapy; Behavioral: Behavioral Activation

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Behavioral Activation
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.	Behavioral: Supportive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	10 item screening instrument for alcohol use	24 hours
Change from baseline in Alcohol Disorders Identification Test (AUDIT)	10 item screening instrument for alcohol use	6 months
Change from baseline in Alcohol Disorders Identification Test (AUDIT)	10 item screening instrument for alcohol use	12 months
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.	24 hours
Change from baseline in The Sheehan Disability Scale (SDS)		6 months
Change from baseline in The Sheehan Disability Scale (SDS)		12 months
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)	9 item self rating instrument of activation and avoidance.	24 hours
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)	9 item self rating instrument of activation and avoidance.	Weekly druing treatment period of 6 weeks
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)	9 item self rating instrument of activation and avoidance.	6 months
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)	9 item self rating instrument of activation and avoidance.	12 months
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	6 months
Change from baseline in sick leave and employment status		12 months
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).	24 hours
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.	6 months
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.	12 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.	24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.	6 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.	12 months
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.	24 hours
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.	6 months
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.	12 months
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.	24 hours
Change from baseline in Clinical Global Impression (CGI)		6 months
Change from baseline in Clinical Global Impression (CGI)		12 months
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.	6 months
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.	12 months

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Director: Per Söderberg, PhD, The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden; Study Chair: 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; Principal Investigator: Fredrik Folke, PhD-student, Department of Neuroscience, Psychiatry, Uppsala University, Sweden

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Behavioral Activation; Continuity of Care; Acute Inpatient Psychiatry
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Problem Behavior; Mental Disorders
• Other Study ID Numbers: Dnr 2012 / 226