Medication Free Treatment: Characteristics, Justification and Outcome
NCT ID: NCT03499080
Last Updated: 2022-08-29
Study Results
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Basic Information
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UNKNOWN
183 participants
OBSERVATIONAL
2018-05-14
2023-04-01
Brief Summary
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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?
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Detailed Description
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Status of knowledge The project has been controversial, especially with reference to the status of knowledge. Critiques have stated that the knowledge base for treating serious psychiatric disorders without medication is lacking (Gundersen, 2016; Røssberg, 2016). Concerns are raised about whether it can be harmful (Røssberg, 2016), whether it is necessary (Røssberg, Andreassen, \& Malt, 2016) and whether it creates unfortunate dividing lines within health care (Røssberg et al., 2016). National guidelines recommend considering/offering medication for bipolar disorders, deep depression and psychosis (Helsedirektoratet, 2009, 2012, 2013). On the other hand, the knowledge base for use of psychotropic drugs is also being questioned, especially regarding long term effects (Bentall, 2009; Forand \& DeRubeis, 2013; Moncrieff, 2009; Sohler et al., 2016; Whitaker, 2010/2014 (no), 2016). Studies on medication are amongst others criticized for not taking withdrawal effect sufficiently into account (Bentall, 2009; Forand \& DeRubeis, 2013; Moncrieff, 2009; Whitaker, 2010/2014 (no), 2016). A randomized controlled study by Wunderink, Nieboer, Wiersma, Sytema, and Nienhuis (2013) indicates a follow up period of at least 3 years is necessary to see the benefits of drug reduction regarding antipsychotics.
Summing up, one can argue that generally, a considerable research base point to psychosocial treatment methods having an important place in the treatment of most psychiatric problems (Lambert, 2013; Wampold, 2001; Wampold \& Imel, 2015). The more specific questions regarding pure psychosocial treatment for serious disorders and long term effects of psychotropic drugs are at least disputable, and probably under-researched.
Research questions
1. Does medication free treatment differ from treatment as usual? Patient characteristics, treatment received, experience, medication use.
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? Hypotheses The treatment outcome of medication free treatment is not inferior to treatment as usual.
Patients in medication free treatment will use less medication. Medication withdrawal may affect outcome in the short run.
Project methodology The design of the study is a mixed methods, observational design within a naturalistic treatment setting using qualitative and quantitative methods to address the research questions.
Moenga consist of two units, the medication free unit and a regular unit, which will be included for comparison. In addition we include a treatment unit on a different location for comparison; DPS Myrvegen. We aim for at least 200 n.
One complication is that this autumn it was decided that the units at Moenga shall move and reorganize sometime during 2018. This entail change of location, possible reorganizing of personnel and that the comparison unit at Moenga is joined with another inpatient unit at the new location. This may cause disruptions that can affect our results. We will study possible effects of this in our data, and may exclude parts of the gathered data and prolong the inclusion period.
We will collect survey data at start of treatment, weekly during treatment, at end of treatment (Work package 1), and at 6 months, 1 year, 2 years and 3 years follow up (work package 3). Register data will be collected 3 years back and 3 years follow up (work package 3). Patient interviews (work package 2) and personnel interviews (work package 4) are performed during spring 2018, the patient interviews near the end of the treatment stay. See measures for details.
Plan for data analyses Quantitative and qualitative analyses will be done according to the research questions. We will seek to compare the medication free unit and treatment as usual. Calculating propensity scores in the observational part of the study will be considered, to balance comparison groups (Austin, 2011).
Statistical power Exact power calculations are only possible in concrete, delimited statistical designs, and must necessarily be based on assumptions not always known before starting the study. In a design with 200 persons the total effect of one-way analysis of variance yield a statistical power of .80 for small to medium effect sizes. That is, the probability of detecting differences between groups will be .80 for effect sizes in the range .40 -.50. For pairwise comparisons between groups (with N=50), the probability of detecting effects in the range of Cohen's d \>=. 40 will be about .80. In Cohen's pragmatic system, effect sizes with such magnitudes represent a "small to medium effect size". These estimations will also apply to change-scores between two points in time, given that the correlation between the two repeated measurements are r \>= .5.
Study plan
Data collection:
Work package 1: Inclusion of patients for quantitative measurements starts April 2018 with a 12 months inclusion period. This may be prolonged if necessary.
Work package 2: Patient interviews will be performed during spring 2018. Work package 3: Follow up measures and register data will be collected until spring 2022.
Work package 4: Personnel interviews will be performed during spring 2018. Analysis Qualitative analyses will be performed within end of 2018. Quantitative analyses will start January 2019 Publishing Publishing of the results in scientific papers will take place mainly in 2019-2023.
Articles
1. "Medication free treatment: Does it differ from treatment as usual?" This article will address research question 1 and include qualitative data, Collaborate, BMQ, Inspire, CSQ-8, WAI, treatment received, use of medication and background data.
2. "Medication free treatment: Why?" This article will address research question 2 (Why do patients choose medication free treatment) and include qualitative data.
3. "Medication free treatment: Does it work?" This article will address the research questions and will include the outcome measures OQ-45, AII, Quality of life, HoNOs, GAF, CGI, drug use, diagnoses and register data. We will also look for correlations between use of medication and outcome, and therefore include measures of medication use.
Research group PhD Kristin S. Heiervang, head of the research group Quality and implementation in Mental Health Services at Akershus university hospital, is project manager (principal investigator) for the project.
Anders S. Wenneberg, specialist in clinical psychology, is the leader of the inpatient treatment facility. Wenneberg is also the project manager of the "Medication Free Treatment" at Akershus University Hospital, Moenga.
Ole André Solbakken is associate professor of clinical psychology and head of section at the Department of Psychology, University of Oslo.
Odd Arne Tjersland is professor of clinical psychology at the Department of Psychology, University of Oslo.
Jon T. Monsen is professor of clinical psychology at the Department of Psychology, University of Oslo.
Allan Abbass is professor, psychiatrist, and founding Director of the Centre for Emotions and Health at Dalhousie University in Halifax, Canada.
Kari Standal will be the PhD candidate. She is a psychologist at Akershus university hospital, specialized in adult treatment and psychotherapy (group treatment and affect consciousness).
Jill Arild, board member of "Mental Helse" and leader of the action group for medication free treatment is user represantive in the project.
Astrid Ringen Martinsen is a psychology student who will write her main thesis on the qualitative patient data.
Ingrid Engeseth Brakstad is a psychology student who will write her main thesis on the qualitative personnel data.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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).
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).
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).
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).
Interventions
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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).
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).
Treatment as usual Åråsen
Unit colocated with the medication free unit. Similar treatment program. Short treatment duration (average 3 weeks).
Eligibility Criteria
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Inclusion Criteria
* 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
* Beds dedicated acute crisis and usercontrolled beds
18 Years
100 Years
ALL
No
Sponsors
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University of Oslo
OTHER
University Hospital, Akershus
OTHER
Responsible Party
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Kristin Sverdvik Heiervang
Researcher Psychologist Phd
Principal Investigators
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Kristin Heiervang, PhD
Role: PRINCIPAL_INVESTIGATOR
Akershus universitetssykehus
Locations
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DPS Øvre Romerike Døgn
Jessheim, , Norway
DPS Nedre Romerike døgn
Lillestrøm, , Norway
Countries
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References
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Aksjon for medisinfrie tilbud. www.medisinfrietilbud.no. Retrieved from http://medisinfrietilbud.no
Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sorensen HT, von Elm E, Langan SM; RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015 Oct 6;12(10):e1001885. doi: 10.1371/journal.pmed.1001885. eCollection 2015 Oct.
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.
Sohler N, Adams BG, Barnes DM, Cohen GH, Prins SJ, Schwartz S. Weighing the evidence for harm from long-term treatment with antipsychotic medications: A systematic review. Am J Orthopsychiatry. 2016;86(5):477-85. doi: 10.1037/ort0000106. Epub 2015 Dec 14.
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
Wunderink L, Nieboer RM, Wiersma D, Sytema S, Nienhuis FJ. Recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy: long-term follow-up of a 2-year randomized clinical trial. JAMA Psychiatry. 2013 Sep;70(9):913-20. doi: 10.1001/jamapsychiatry.2013.19.
Standal K, Solbakken OA, Rugkasa J, Halvorsen MS, Abbass A, Wirsching C, Brakstad IE, Heiervang KS. Medication-Free Treatment in Mental Health Care How Does It Differ from Traditional Treatment? Patient Prefer Adherence. 2024 Feb 3;18:315-335. doi: 10.2147/PPA.S435610. eCollection 2024.
Other Identifiers
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medicationfree
Identifier Type: -
Identifier Source: org_study_id
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