Behavioral Activation - From Inpatient to Outpatient Services

Not Applicable

Completed

• Conditions: Inpatient Facility Diagnoses; Psychiatric Disorders; Depressive Symptoms
• Interventions: Behavioral: Behavioral Activation; Behavioral: Supportive Therapy

• Registration Number: NCT01786733
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-08
• Study Start: 2013-03
• Primary Completion: 2016-03
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Activation	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.
Supportive Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)	12 months

Secondary Outcome Measures

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