Behavioral Activation - From Inpatient to Outpatient Services

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786733
• Other study ID #: Dnr 2012 / 226
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: May 2, 2017
• Start date: March 2013
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Inpatient Facility Diagnoses
• Mental Disorders
• Problem Behavior
• Psychiatric Disorders

Intervention

Behavioral:
• Behavioral Activation

• Supportive Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)		24 hours
Primary	Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)		6 months
Primary	Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)		12 months
Secondary	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
Secondary	Change from baseline in EuroQol 5 Dimension Scale (EQ5D)		6 months
Secondary	Change from baseline in EuroQol 5 Dimension Scale (EQ5D)		12 months
Secondary	Change from baseline in Alcohol Disorders Identification Test (AUDIT)	10 item screening instrument for alcohol use	24 hours
Secondary	Change from baseline in Alcohol Disorders Identification Test (AUDIT)	10 item screening instrument for alcohol use	6 months
Secondary	Change from baseline in Alcohol Disorders Identification Test (AUDIT)	10 item screening instrument for alcohol use	12 months
Secondary	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
Secondary	Change from baseline in The Sheehan Disability Scale (SDS)		6 months
Secondary	Change from baseline in The Sheehan Disability Scale (SDS)		12 months
Secondary	Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)	9 item self rating instrument of activation and avoidance.	24 hours
Secondary	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
Secondary	Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)	9 item self rating instrument of activation and avoidance.	6 months
Secondary	Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)	9 item self rating instrument of activation and avoidance.	12 months
Secondary	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
Secondary	Change from baseline in sick leave and employment status		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in Clinical Global Impression (CGI)		6 months
Secondary	Change from baseline in Clinical Global Impression (CGI)		12 months
Secondary	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
Secondary	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