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Medication Free Treatment: Characteristics, Justification and Outcome

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ClinicalTrials.gov Identifier: NCT03499080
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Kristin Sverdvik Heiervang, University Hospital, Akershus

Brief Summary:

In 2015 the Norwegian government, after initiative from user organizations, decided to implement medication free inpatient treatment units. The goal is to secure real options to medication for psychiatric illness, and to gather experiences with medication free options. Freedom of choice is a main concern.

The projects main aim is to study the outcome of medication free treatments of mental illness compared to treatment as usual, as well as characteristics of the treatment and the treatment population and why patients choose this treatment. Hereunder we aim to document who asks for these kinds of services and why, what kind of treatment they get, how they experience it, and how they respond to this kind of treatment. An important part will be to document whether the goal of increased freedom of choice between real treatment options is fulfilled.

Research questions

  1. Does medication free treatment differ from treatment as usual? Are there any unique characteristics of the patient group who asks for this kind of treatment? What kind of treatment do they receive during their stay? How do they experience this treatment in comparison to treatment as usual? How is this in relation to the goals about increased freedom of choice? Does use of medication change during and/or after medication free treatment?
  2. Why do patients choose medication free treatment? What are their reasons? What experiences lead to this wish?
  3. What is the outcome of medication free treatment compared to treatment as usual?

Condition or disease Intervention/treatment
Mental Illness Behavioral: Medication free treatment Behavioral: Treatment as usual Myrvegen Behavioral: Treatment as usual Åråsen

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Medication Free Treatment: Characteristics, Justification and Outcome
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : May 14, 2020
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Group/Cohort Intervention/treatment
Patients in medication free treatment
Inpatient unit dedicated to medication free treatment. This is an inpatient treatment unit for voluntary, planned treatment. The unit is staffed for a patient group that can be managed within a regime of open doors, voluntary treatment and low supervision. This means that high suicidal risk, severe acting out, active drug abuse etc. is excluded. They have an 8 week treatment program including Illness managment an recovery (IMR), Feedback informed treatment (FIT) and Affect consciousness treatment (ABT).
Behavioral: Medication free treatment
Inpatient unit dedicated to medication free treatment. This is an inpatient treatment unit for voluntary, planned treatment. The unit is staffed for a patient group that can be managed within a regime of open doors, voluntary treatment and low supervision. This means that high suicidal risk, severe acting out, active drug abuse etc. is excluded. They have an 8 week treatment program including Illness managment an recovery (IMR), Feedback informed treatment (FIT) and Affect consciousness treatment (ABT).

Patients in treatment as Usual Åråsen
Inpatient unit colocated with the medication free unit. Same level of care. Similar treatment program, shorter treatment duration (on average 3 weeks).
Behavioral: Treatment as usual Åråsen
Unit colocated with the medication free unit. Similar treatment program. Short treatment duration (average 3 weeks).

Patients in treatment as Usual Myrvegen
Inpatient unit on a different location from the others. Same Level of care. Different treatment program. Intermediate treatment duration (mainly 4-6 weeks).
Behavioral: Treatment as usual Myrvegen
Inpatient unit on a different location from the others. Same Level of care. Different treatment program. Intermediate treatment duration (mainly 4-6 weeks).




Primary Outcome Measures :
  1. Outcome Questionnaire-45 (OQ-45) [ Time Frame: Filled out by patients at start of treatment, 1 time every week during the treatment program (typically 2 to 8 weeks), 1 time at end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    This questionnaire was developed for tracking outpatients on a weekly basis. It measures symptom distress, interpersonal functioning and contentment with social role functioning, areas widely recognized as the essential ingredients of interest when assessing patient improvement. It is regarded suitable for patients with a wide range of diagnoses, sensitive to change over a short period of time, and brief and easy to administer (Lambert, Hansen, & Finch, 2001).


Secondary Outcome Measures :
  1. The Working Alliance Inventory (WAI-SP) [ Time Frame: Filled out by patients at start of treatment, 1 time every week during the treatment program (typically 2 to 8 weeks), 1 time at end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    The WAI is one of the most widely used measures in research on working alliance and measures three aspects of the collaborative, purposive work in therapy: Bond, Task, and Goal. Research indicates that Bond, Task, and Goal represent the multidimensional construct working alliance is assumed to be (Horvath, 1994; ref. in Hersoug et al., 2009). WAI items are rated on a 7-point Likert-type scale ranging from 1 (never) to 7 (always), assessing the extent to which patient and therapist explicitly agree on the tasks and goals of therapy and the quality of the affective bond between them.

  2. Beliefs about medicines questionnaire (BMQ) [ Time Frame: Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about mcdicines in general. The pool of test items was derived from themes identified in published studies and from interviews with chronically ill patients. Principal Component Analysis (PCA) of the test items resulted in a logically coherent. 18 item, 4-factor structure which was stable across various illness groups. In this study we use the BMQ-Specific. The BMQ-Specific comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication bascd on beliefs about the danger of dependence and long-term toxicity and the disruptive effects of medication (Specific-Concern).

  3. INSPIRE measure of staff support for personal recovery [ Time Frame: Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    INSPIRE measure of staff support for personal recovery version 3 is included because the Recovery-tradition is a central part of the treatment program. Inspire has two subscales; Support and Relationship. The scale has demonstrated adequate psychometric properties (Williams et al., 2015).

  4. CollaboRATE [ Time Frame: Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    Collaborate is a 3-item measure of shared decision making. CollaboRATE assesses three core SDM tasks: (1) explanation about health issues, (2) elicitation of patient preferences and (3) integration of patient preferences into decisions (Paul J. Barr et al., 2017). It has been found to have adequate psychometric properties in both simulated (Paul James Barr et al., 2014) and clinical (Paul J. Barr et al., 2017) settings.

  5. The Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    The Client Satisfaction Questionnaire-8 (CSQ-8) is an eight item questionnaire for measuring patient's global satisfaction with services. It has been shown to correlate well with the longer version, CSQ-18, and has shown good psychometric qualities regarding internal consistency, attendance, remainer-terminator status and greater client-reported symptomreduction (Attkisson & Zwick, 1982)

  6. Affect Integration Inventory 42 (AII-42) [ Time Frame: Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    Affect Integration Inventory 42 (AII-42) is a short version of AII, a medium-length (112 items) self-rated assessment instrument that endeavors to measure capacities for experience and expression of nine affect states. These are important parts of the construct affect integration, the capacity to utilize affects for personal adjustment. A recent study has found satisfactory reliability, sound internal structure, and associations with external criteria, indicating good convergent and discriminant validity (Solbakken, Rauk, Solem, Lødrup, & Monsen, 2017).

  7. Life satisfaction question [ Time Frame: Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years ]
    One question regarding life satisfaction from the project from the MANSA instrument (Clausen et al., 2015).

  8. Questions regarding whether they specifically sought medication free treatment and why [ Time Frame: Filled out by patients at start of treatment. ]
    Questions regarding whether they specifically sought medication free treatment and why (self-developed)

  9. Background data [ Time Frame: Filled out by patients at start of treatment. ]
    Sosiodemographic data, contact with family and network, caregiving, juridical information, health service use, health history, drug use, physical health, health history (from the project "Bedre psykosebehandling").

  10. Treatment received [ Time Frame: Filled out by patients at end of treatment (typically week 2-8). ]
    A form regarding what kind of treatment they have received during the stay, and benefit (adapted from Sintef Unimed, 2002)

  11. Use of drugs [ Time Frame: Filled out by patients at start of treatment, at 6 months, 1 year, 2 years and 3 years ]
    Use of drugs (questions from the project "Bedre psykosebehandling").

  12. The Clinical Global Impressions Scale (CGI) [ Time Frame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8) ]
    The Clinical Global Impressions Scale (CGI) was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication (Guy, 1976; ref. in Busner & Targum, 2007) The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI can track clinical progress across time and has been shown to correlate with longer, more tedious and time consuming rating instruments across a wide range of psychiatric diagnoses (Busner & Targum, 2007).

  13. Health of the Nation Outcomes Scales (HoNOS) [ Time Frame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8). ]
    Health of the Nation Outcomes Scales (HoNOS) was developed to routinely measure outcomes for adults with mental illness. It is regarded adequate for assessing outcomes for different groups on a range of mental health-related constructs, and appropriate for routinely monitoring outcomes (Pirkis et al., 2005).

  14. Global assessment of functioning (GAF) [ Time Frame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8). ]
    Global assessment of functioning (GAF) is one of the axes in the DSM diagnostic system from version III-R (Ullevål personlighetsprosjekt) until version 5. The multiaxial system was discarded in version 5 (Kress, Minton, Adamson, Paylo, & Pope, undated). From 1998 Statens helsetilsyn recommended all health institutions to use a minimum set of basic data ("minste basis datasett") which included a split version of GAF called S-GAF (Ullevål personlighetsprosjekt). The patient is ranged on two scales from 0-100 regarding symptoms and functioning. The psychometric properties of GAF are disputed (Kress et al., undated), but the measure is short, widely applied and mandatory in hospitals and therefore we include it.

  15. Scale on alcohol (AUS) [ Time Frame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8). ]
    Scale on alcohol (AUS (Drake et al., 1990)

  16. Scale on drugs (DUS) [ Time Frame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8). ]
    Scale on drugs (Mueser et al., 1995))

  17. Diagnoses [ Time Frame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8). ]
    Diagnoses (including information on any diagnostic procedures used) (questions from the project "Bedre psykosebehandling").

  18. Treatment received [ Time Frame: Filled out by clinician at end of treatment (typically week 2-8). ]
    Treatment received (scheme adapted from SINTEF Helse, 2005).

  19. Patient interviews [ Time Frame: The interviews will be done close to the end of the treatment program (typically week 7). ]
    experience the treatment program, differences to other treatment they have been in and experience of freedom of choice regarding medication and other ways of coping. Interview guides will be developed by the phd candidate and a psychology student. The student will do pilot testing of the interview.

  20. Register data [ Time Frame: Register data will be documented at baseline, and at 6 months, 1 year, 2 years and 3 years follow up. ]
    We will seek approval and consent to get data from national official registers on health and use of health services (Norwegian Patient Register, HELFO for primary health and social care, NAV).

  21. Staff interviews [ Time Frame: The interviews are performed during spring 2018 ]
    Interviews with staff on the medication free unit for exploring characteristics and differences to treatment as usual

  22. Register data from the Medication Prescription Register [ Time Frame: Collected at 3 years before treatment start, 2 years before, 1 year before, 6 months post treatment, 1 year post treatment, 2 years post treatment and 3 years post treatment ]
    Use of prescribed psychothropic medication

  23. Questionnaire on medication filled out by patients [ Time Frame: at start of treatment, at 6 monts, 1 year, 2 years and 3 years. ]
    Questionnaire regarding psychotrophic medication based on questions from the project "Bedre psykosebehandling"

  24. Questionnaire on medication filled out by clinician [ Time Frame: at start of treatment and end of treatment (typically at 2-8 weeks) ]
    Questionnaire regarding psychotrophic medication based on questions from the project "Bedre psykosebehandling"

  25. Help with medication filled out by patient [ Time Frame: at start of treatment, end of treatment (typically at 2-8 weeks) and at 6 months, 1 year, 2 years and 3 years. ]
    Help with medication: Questions developed in the project "Bedre psykosebehandling" about perceived quality of help and information regarding medication (Prosjekt Bedre psykosebehandling, n.d.).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with mental illness in the regions Øvre and Nedre Romerike who receive medication free treatment or treatment as usual at the same level of care (planned, voluntary inpatient treatment at DPS døgn) within the period from spring 2018 and 1-2 years forward, who are able to fill out forms / be interviewed in Norwegian and concent to participate.
Criteria

Inclusion Criteria:

  • Receiving planned treatment in the included treatment units
  • Are able to fill out questionnaires in Norwegian with minimal help / be interviewed in norwegian
  • Signed informed consent and willing to participate in the trial

Exclusion Criteria:

  • Not able to fill out questionnaires or be interviewed in Norwegian.
  • Beds dedicated acute crisis and usercontrolled beds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499080


Contacts
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Contact: Kristin Heiervang, PhD +4790150138 Kristin.S.Heiervang@ahus.no
Contact: Kari Standal, Master +4798468372 Kari.Standal@ahus.no

Locations
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Norway
DPS Øvre Romerike Døgn Recruiting
Jessheim, Norway, 2050
Contact: Gunn Borgen    63941250    gunn.borgen@ahus.no   
Contact: Jorunn Iversen       jorunn.iversen@ahus.no   
DPS Nedre Romerike døgn Recruiting
Lillestrøm, Norway, 2007
Contact: Anders Skogen Wenneberg, Master    92224542    anders.skogen.wenneberg@ahus.no   
Contact: Lene Paulsen    67966300    lene.paulsen@ahus.no   
Sponsors and Collaborators
University Hospital, Akershus
University of Oslo
Investigators
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Principal Investigator: Kristin Heiervang, PhD Akershus universitetssykehus

Additional Information:

Publications:
Aksjon for medisinfrie tilbud. www.medisinfrietilbud.no. Retrieved from http://medisinfrietilbud.no
Bentall, R. (2009). Doctoring the Mind. Why Psychiatric Treatments fail. London: Penguin Books.
Forand, N. R., & DeRubeis, R. J. (2013). Combining medication and psychotherapyin the treatment of major mental disorders. In M. J. Lambert (Ed.), Bergin & Garfield's handbook of psychotherapy and behaviour change (6. ed., pp. 735-775). Hoboken, New Jersey: John Wiley & Sons inc.
Gundersen, K. (2016). Medikamentfri psykiatri - eksperiment uten forskning. Aftenposten.
Helse Sør-Øst. (2016). Overordnet protokoll for medisinfri behandling innen psykisk helsevern.
Helsedirektoratet. (2009). Nasjonal retningslinje for diagnostisering og behandling av depresjon i primær- og spesialisthelsetjenesten. ( IS-1561).
Helsedirektoratet. (2012). Nasjonal faglig retningslinje for utgreiing og behandling av bipolare lidingar (IS-1925). Helsedirektoratet.
Helsedirektoratet. (2013). Nasjonal faglig retningslinje for utredning, behandling og oppfølging av personer med psykoselidelser ( IS-1957). Helsedirektoratet.
Lambert, M. J. (2013). The efficacy and effectiveness of psychotherapy. In M. J. Lambert (Ed.), Bergin & Garfield's handbook of psychotherapy and behavior change (6. ed., pp. 169-219). Hoboken, New Jersey: John Wiley & sons, inc.
Moncrieff, j. (2009). A straight talking Introduction to Psychiatric drugs. Herefordshire: PCCS Books.
Røssberg, j. i. (2016, 13.06.16). Det er langt fra sikkert at det riktige er å innføre medisinfritt behandlingstilbud. Aftenposten.
Røssberg, j. i., Andreassen, O. A., & Malt, U. (2016, 17.07.16). Medisinfrie tiltak for psykoselidelser er fortsatt et sjansespill. Aftenposten.
Wampold, B. E. (2001). The Great Psychotherapy Debate. Models, Methods and Findings (2 ed.). Mahwah, New Jersey: Lawrence Erlbaum Associates publishers.
Wampold, B. E., & Imel, Z. E. (2015). The Great Psychotherapy Debate. The Evidence for what makes Psychotherapy work (2 ed.). New York, London: Routledge, Taylor &Francis Group.
Whitaker, R. (2010/2014 (no)). En psykiatrisk epidemi. Illusjoner om psykiatriske legemidler. Oslo: Abstract forlag.
Whitaker, R. (2016). The case against antipsychotics. A review of their long-term effect. Weblog: Mad in America

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Responsible Party: Kristin Sverdvik Heiervang, Researcher Psychologist Phd, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03499080     History of Changes
Other Study ID Numbers: medicationfree
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kristin Sverdvik Heiervang, University Hospital, Akershus:
Medication free treatment, mental illness, outcome

Additional relevant MeSH terms:
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Mental Disorders