Inpatient Facility DiagnosesNCT01786733
Behavioral Activation - From Inpatient to Outpatient Services
A study testing Behavioral Activation and Supportive Therapy in people with Inpatient Facility Diagnoses and Psychiatric Disorders, run by Uppsala University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inpatient Facility Diagnoses, Psychiatric Disorders, Depressive Symptoms
- What is being tested?
- Behavioral Activation and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Behavioral Activation, Supportive Therapy
- Keywords
- Acute Inpatient Psychiatry, Continuity of Care, Behavioral Activation, Depression
- Medical subject headings
- Mental Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Supportive TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | 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. Receives: Behavioral: Behavioral Activation |
| Supportive Therapy | Active comparator | 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. Receives: Behavioral: Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly during treatment period of 6 weeks
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
Measured: 24 hours
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
Measured: 6 months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
Measured: 12 months
Secondary outcomes (29)
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.
Measured: 24 hours
Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
Measured: 6 months
Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
Measured: 12 months
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
10 item screening instrument for alcohol use
Measured: 24 hours
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
10 item screening instrument for alcohol use
Measured: 6 months
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
10 item screening instrument for alcohol use
Measured: 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.
Measured: 24 hours
Change from baseline in The Sheehan Disability Scale (SDS)
Measured: 6 months
Change from baseline in The Sheehan Disability Scale (SDS)
Measured: 12 months
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
9 item self rating instrument of activation and avoidance.
Measured: 24 hours
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
9 item self rating instrument of activation and avoidance.
Measured: 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.
Measured: 6 months
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
9 item self rating instrument of activation and avoidance.
Measured: 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
Measured: 6 months
Change from baseline in sick leave and employment status
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Change from baseline in Clinical Global Impression (CGI)
Measured: 6 months
Change from baseline in Clinical Global Impression (CGI)
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inpatient Facility DiagnosesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Folke, Uppsala University
- Investigators
- Per Söderberg, PhD, Study director, The Adult Psychiatric Clinic of Landstinget Dalarna, SwedenLisa Ekselius, Professor, Study chair, Department of Neuroscience, Psychiatry, Uppsala University, SwedenStefan Tungström, PhD, Study chair, The Adult Psychiatric Clinic of Landstinget Dalarna, SwedenTimo Hursti, PhD, Study chair, The Department of Psychology, Uppsala University, SwedenFredrik Folke, PhD-student, Principal investigator, Department of Neuroscience, Psychiatry, Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786733
- Sponsor's protocol ID
- Dnr 2012 / 226
- Status last verified
- May 2017
- First submitted
- 29 Jan 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services - A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy
- ClinicalTrials.gov ID
- NCT01786733
- Acronym / sponsor ID
- Dnr 2012 / 226
- Keywords
- Acute Inpatient Psychiatry, Continuity of Care, Behavioral Activation, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral ActivationBehavioral 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 | Active comparator | Behavioral: Supportive TherapySupportive 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Acute psychotic symptoms
- Acute manic symptoms
- Confusion
- Primary eating disorder
- Primary alcohol or substance abuse disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation | Behavioural | Behavioral Activation |
| Supportive Therapy | Behavioural | Supportive Therapy |
Primary outcome
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
29 secondary outcomes
Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
Time frame: 24 hours
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
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
Time frame: 6 months
Change from baseline in Alcohol Disorders Identification Test (AUDIT)
Time frame: 12 months
Change from baseline in The Sheehan Disability Scale (SDS)
Time frame: 24 hours
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
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
Time frame: Weekly druing treatment period of 6 weeks
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
Time frame: 6 months
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
Time frame: 12 months
Change from baseline in sick leave and employment status
Time frame: 6 months
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
Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
Time frame: 6 months
Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
Time frame: 12 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 6 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 12 months
Change from baseline in Global Assessment of Functioning (GAF)
Time frame: 24 hours
Change from baseline in Global Assessment of Functioning (GAF)
Time frame: 6 months
Change from baseline in Global Assessment of Functioning (GAF)
Time frame: 12 months
Change from baseline in Clinical Global Impression (CGI)
Time frame: 24 hours
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
Change from baseline in Usage of mental health care
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Supportive Therapy in people with Inpatient Facility Diagnoses and Psychiatric Disorders, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S) (time frame: Weekly during treatment period of 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.