Collabri Flex - Effect of Collaborative Care for People With Depression in General Practice

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Anxiety Depression	Behavioral: Collaborative care Other Names Behavioral: Consultations-Liaison Other Names	N/A

Tracking Information

First Submitted Date	April 10, 2017
Last Update Posted Date	April 10, 2017
Anticipated Start Date	May 01, 2017
Anticipated Completion Date	November 01, 2018
Anticipated Primary Completion Date	November 01, 2018
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• Self-reported degree of depression [Time Frame: 6 months]

  Measured by Beck Depression Inventory (BDI)

Original Primary Outcome Measures

Current Secondary Outcome Measures

• Self-reported degree of anxiety [Time Frame: 6 months]

  Measured by Beck anxiety Inventory (BAI)

• Self-reported psychological stress [Time Frame: 6 months]

  Measured by Symptom Checklist (SCL-92)

• Self-reported functional impairment [Time Frame: 6 months]

  Measured by Sheehan disability Scale (SDS)

• Self-reported quality of life [Time Frame: 6 months]

  Measured by WHO-5

• Self-reported side effects [Time Frame: 6 months]

  Measured by PRISE

• Sick leave [Time Frame: 6 months]

  Obtained from the DREAM database

• Self-reported self-efficacy [Time Frame: 6 monts]

  Measured by personal control (IPQ-R scale) and two subscales from the Chronic Disease Self-Efficacy Scales (SECD-32); Obtain help from Comunity, Family, Friends Scale and Control/manage Depression Scale

• Self-reported health-related quality of life [Time Frame: 6 months]

  Measured by EQ-5D

Original Secondary Outcome Measures

Study Design

Brief Title	Collabri Flex - Effect of Collaborative Care for People With Depression in General Practice
Official Title	Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice
Brief Summary	The aim of the study Collabri Flex is to: - Develop a Danish model for collaborative care for patients with depression in general practice, based on past experience gained in the Collabri Project. - Examine the impact of this model compared with liaison-consultation for people with depression in a randomized controlled design from selected endpoints.
Detailed Description	The Collabri Flex model for Collaborative Care takes point of departure in the earlier study Collabri. It is changed according to gathered information under the first study of the Collabri model in order to achieve a Danish Collaborative Care model easier to implement. The aims of Project Collabri Flex are to: - Develop a flexible model for collaborative care (the Collabri Flex model) for patients with depression. - Study the effects of this Collabri Flex model against consultation liaison in a randomized design on selected outcomes. In Collabri the treatment is in line with a set of general treatment principles relevant for collaborative care interventions. The patients in the intervention group are offered cognitive behavioral therapy (CBT), psychoeducation and medication according to a stepped care model by a care manager refering to the general practitioner. The Collabri Flex study is set up as a researcher-blinded individually randomized controlled trial with participation of an intervention group (treatment according to the Collabri Flex model) and a consultation liaison group. This study will contribute with new knowledge on collaborative care interventions in a Scandinavian context.
Study Type	Interventional
Study Phase	N/A
Estimated Enrollment	240
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
Conditions	Anxiety Depression
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Behavioral: Collaborative care Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model Other Names Behavioral: Consultations-Liaison Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist). Other Names
Study Groups/Cohorts	Collabri Flex Collaborative care Consultation-Liaison Consultations with general practitioner
Study Arms	Experimental Collabri Flex Collaborative care Behavioral : Collaborative care Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model Experimental Consultation-Liaison Consultations with general practitioner Behavioral : Consultations-Liaison Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

Arm	Intervention/Treatment
Experimental Collabri Flex Collaborative care	Behavioral : Collaborative care Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model
Experimental Consultation-Liaison Consultations with general practitioner	Behavioral : Consultations-Liaison Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

Recruitment Information

Recruitment Status:	Not yet recruiting
Enrollment	240
Completion Date	November 01, 2018
Eligibility Criteria:	Inclusion Criteria: - Danish speaking - Diagnosis of current depression based on the Mini International Neuropsychiatric Interview (MINI) by care managers that have been trained in using MINI (12) in close collaboration with the psychiatrist/psychologist. - The patient has given her/his written informed consent to participate in the trial at the described terms Exclusion Criteria: - High risk of suicide assessed in the Mini International Neuropsychiatric Interview (MINI) and/or by the GP - Psychotic condition detected in the MINI and/or by the GP - Patients with a diagnosis of dementia - Alcohol or substance misuse that hinders the person participating in Collabri treat-ment as assessed by the practitioner or care manager at inclusion interview. - Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression - For patients in the Collabri Flex group: Patients with depression who wants treat-ment cf. the psychologist scheme (Psykologordningen) and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP - If the patient before or at the first point of contact with the GP after inclusion by care manager is referred to treatment as a part of the secondary psychiatric care system - Patients who are assessed by the GP as medically unstable making it impossible for the patient to adhere to treatment - OCD, PTSD, bipolar affective disorder as assessed in the MINI and/or by the GP.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Lene Falgaard Eplov, MD, PhD +45 38647461 [email protected] Ursula Brinck-Claussen, MD, PhD student +45 20952540 [email protected]
Listed Location Countries	Not Available

Administrative Information

NCT Number:	NCT03113201
Other Study ID Numbers	Collabri Flex - Depression
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Lene Falgaard Eplov, Mental Health Centre Copenhagen
Study Sponsor	Mental Health Centre Copenhagen
Collaborators	Not Available
Investigators	Not Available