Behavioral Activation - From Inpatient to Outpatient Services

May 2, 2017 updated by: Fredrik Folke, Uppsala University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Weekly during treatment period of 6 weeks
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
Time Frame: 24 hours
24 hours
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
Time Frame: 6 months
6 months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 hours
Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
Time Frame: 6 months
6 months
Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
Time Frame: 12 months
12 months
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
Time Frame: 24 hours
10 item screening instrument for alcohol use
24 hours
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
Time Frame: 6 months
10 item screening instrument for alcohol use
6 months
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
Time Frame: 12 months
10 item screening instrument for alcohol use
12 months
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.
24 hours
Change from baseline in The Sheehan Disability Scale (SDS)
Time Frame: 6 months
6 months
Change from baseline in The Sheehan Disability Scale (SDS)
Time Frame: 12 months
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.
24 hours
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.
Weekly druing treatment period of 6 weeks
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.
6 months
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.
12 months
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
6 months
Change from baseline in sick leave and employment status
Time Frame: 12 months
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).
24 hours
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.
6 months
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.
12 months
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.
24 hours
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.
6 months
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.
12 months
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.
24 hours
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.
6 months
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.
12 months
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.
24 hours
Change from baseline in Clinical Global Impression (CGI)
Time Frame: 6 months
6 months
Change from baseline in Clinical Global Impression (CGI)
Time Frame: 12 months
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.
6 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr 2012 / 226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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