PsychosisNCT03537040
Piloting MOL Intervention for Neuroleptic Decision Making
A study testing Method of Levels in people with Psychosis and Medication Adherence, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
The aim of the current study is to pilot a novel intervention to help people explore their decision making around the use of neuroleptic medication. A case series design will be used, with outcome variables measured at multiple time points pre-, during- and post-intervention. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Psychosis, Medication Adherence
- What is being tested?
- Method of Levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 Jun 2018to 10 May 2019
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Over 16 years of age
- Capacity to provide informed written consent
- Able to converse in English proficiently
- Currently under the care of an Early Intervention Service or Community Mental Health Team
- Ambivalent around medication use
- Experience of psychosis
- Be able to be assessed in an outpatient facility (exceptions will be made for disabilities)
Who cannot join
- If currently experiencing such a deterioration in mental state that they may have difficulties making decisions in their life
- If significant risk of harm to self or others is present
- If there is an organic basis for psychosis
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Greater Manchester Mental Health NHS Foundation Trust
Manchester
Lancashire Care NHS Foundation Trust
Preston, Lancashire, BB10 4el
About this study
Official title: A Pilot Study to Assess the Feasibility and Acceptability of a Novel Intervention to Help People Think About Their Neuroleptic Medication Use.
The aim of the current study is to pilot a novel intervention to help people explore their decision making around the use of neuroleptic medication. A case series design will be used, with outcome variables measured at multiple time points pre-, during- and post-intervention. Participants will also be asked to complete an evaluation interview post-intervention. The primary aim is to investigate the feasibility and acceptability of offering the intervention.
Read the detailed description
Many service users experiencing psychosis are prescribed neuroleptic medication as the core component of treatment. However, discontinuations rates are high, which may be influenced by poor response rates and scepticism about the value of medication.
Frequently people discontinue without professional involvement, which is associated with negative outcomes. It is a particularly high risk period for relapse, especially if withdrawal is done quickly. There is an urgent need to advance practices in helping service-users to make a decision regarding neuroleptic medication that can then be supported by clinicians.
Current interventions regarding medication use predominantly focus on increasing adherence to medication regimes using, for example, financial incentives. This raises ethical concerns over the potential for service users' priorities and preferences to be disregarded, leading to increased coercion and reduced empowerment for service users. The recovery movement emphasises the need to understand personal priorities when considering treatment options and informed choice and shared-decision making is promoted by government initiatives and practice guidelines.
Shared decision-making commonly occurs within physical health settings. Patient decision aids have been found to improve patients' knowledge of available options and help patients to have more accurate expectations of potential benefits and harms, reach choices that are more consistent with personal values and participate in decision making. Despite this, shared-decision making has not been adopted more widely and is particularly poor within mental health settings.
The current study aims to explore the feasibility and acceptability of an intervention aimed at helping service users in mental health services think about their own personal priorities and decision-making around medication use. Current psychological interventions, such as cognitive behavioural therapy (CBT) and motivational interviewing (MI), view decision-making in terms of individuals making cost-benefit analyses, which then informs their "planned" behaviour. Such interventions thus target the identification of desirable medication related behaviours and then help the individual to make those behaviours occur.
Perceptual Control Theory (PCT) offers an alternative framework in which to understand medication related decision-making and behaviour. PCT regards all behaviour as goal directed but states that individuals control their experiences (or input) not their behaviour (or output). From this perspective, behaviour is understood as a means by which an individual resolves discrepancies between how they currently experience something (a current perception) and the way they want that experience to be. There is recognition that people are usually unaware of many of the different priorities (or goals) they hold, although these priorities/ goals are often incompatible (in conflict). An intervention informed by PCT (Method of Levels; MOL) would, therefore, target increasing an individual's awareness of the different personal priorities/ goals they hold in relation to medication use. The intervention would focus on exploring conflict between personal priorities, as from a PCT perspective; conflict is what causes ambivalence or difficulties in being able to enact certain planned behaviours. The aim in the current study would be to use MOL to help people develop their awareness of what is important to them in relation to medication use, as opposed to focusing on planning specific behaviours.
The aim in the current study would be to use MOL to help people explore their decision around the use of neuroleptic medication. Traditionally the focus of a MOL session is determined by the client and can vary from person to person, however, for this study the sessions will be specifically focused on neuroleptic medication use. The sessions will aim to help people explore a range of thoughts and feelings about decisions around medication use and how these relate to other important life values and goals. Another key aim of sessions will be to help people develop awareness of conflicts in their goals so that they might begin to find potential resolution. Due to the nature of the intervention being very patient-led and idiosyncratic, the outcome will vary from person to person. The intervention does not attempt to increase adherence or encourage discontinuation to the neuroleptic medication. It aims to help people develop awareness of how they feel about using neuroleptic medication and how medication might relate to other things that are important to them in life.
If this is a feasible and acceptable approach to use then future research would explore whether prescribers could incorporate this approach to working in their consultations with service users.
- Conditions
- Psychosis, Medication Adherence
- Being tested
- Method of Levels
- Medical subject headings
- Psychotic Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of LevelsOther
Talking Therapy
| Study group | Role | What they receive |
|---|---|---|
| Method of Levels | Other | Talking therapy- duration and frequency of sessions to be determined by participant Receives: Other: Method of Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited to the study
Number of participants recruited to the study
Measured: through study completion, an average of 5 months.
Number of participants retained during the study
Number of participants retained during the study
Measured: through study completion, an average of 5 months.
Change in therapeutic alliance from baseline to 12 weeks
The Session Rating Scale is a brief therapeutic alliance measure designed for every session clinical use. The SRS is a four-item visual analogue instrument that explores the relationship, goals and topics, approach or method, and how the client perceives the session in total. Scores range between 0 and 40, higher scores suggest better therapeutic alliance.
Measured: baseline, 12 weeks.
Secondary outcomes (5)
Change in treatment-related empowerment from baseline to 12 weeks
The Treatment-related Empowerment Scale assesses the patients perceived degree of involvement within their treatment by assessing components of communication, treatment choice, decisions and satisfaction. The scale consists of 10 items in which respondents rate the extent to which their experience matches each statement on a 5 point Likert scale. High scores represent higher treatment-related empowerment.
Measured: baseline, 12 weeks.
Change in attitude towards medication from baseline to 12 weeks
The Drug Attitude Inventory-10 a 10-item modified version of the Drug Attitude Inventory-30 Questionnaire, commonly used to evaluate medication adherence and captures an individual's general attitude about taking medication. Scores range between -10 and +10, higher scores indicate a more positive attitude towards medication.
Measured: baseline, 12 weeks.
Change in compliance to medication regime from baseline to 12 weeks
Participants will be asked to rate their current compliance using a 4-point scale that was developed for another study (Barrowclough et al., 1999). Scores range from 0-4, higher scores indicate higher compliance.
Measured: baseline, 12 weeks.
Change in personal recovery from baseline to 12 weeks
Questionnaire about the Process of Recovery a 15-item measure used to assess personal recovery. Scores range between 15 and 75, higher scores are indicative of recovery.
Measured: baseline, 12 weeks.
Change in engagement with services from baseline to 12 weeks
The Service Engagement Scale is a 14-item clinician-rated measure that assesses service user engagement with community mental health services. Scores range between 0 and 42, lower scores indicate better engagement.
Measured: baseline, 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start27 Jun 2018
- Primary completion23 Mar 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rea Dicks, University of Manchester
- Investigators
- Sara Tai, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537040
- Sponsor's protocol ID
- 238098
- Status last verified
- May 2019
- First submitted
- 18 Apr 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Annoymous data files for outcome data will be shared on request
Publications
Moncrieff J. Does antipsychotic withdrawal provoke psychosis? Review of the literature on rapid onset psychosis (supersensitivity psychosis) and withdrawal-related relapse. Acta Psychiatr Scand. 2006 Jul;114(1):3-13. doi: 10.1111/j.1600-0447.2006.00787.x.
PubMed 16774655Mansell W, Carey TA. A century of psychology and psychotherapy: is an understanding of 'control' the missing link between theory, research, and practice? Psychol Psychother. 2009 Sep;82(Pt 3):337-53. doi: 10.1348/147608309X432526. Epub 2009 Apr 1.
PubMed 19341533
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility and Acceptability of a Novel Intervention to Help People Think About Their Neuroleptic Medication Use.
- ClinicalTrials.gov ID
- NCT03537040
- Acronym / sponsor ID
- 238098
- Conditions
- Psychosis, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 25 May 2018 (actual)
- 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 aim of the current study is to pilot a novel intervention to help people explore their decision making around the use of neuroleptic medication. A case series design will be used, with outcome variables measured at multiple time points pre-, during- and post-intervention. Participants will also be asked to complete an evaluation interview post-intervention. The primary aim is to investigate the feasibility and acceptability of offering the intervention.
Detailed description
Many service users experiencing psychosis are prescribed neuroleptic medication as the core component of treatment. However, discontinuations rates are high, which may be influenced by poor response rates and scepticism about the value of medication.
Frequently people discontinue without professional involvement, which is associated with negative outcomes. It is a particularly high risk period for relapse, especially if withdrawal is done quickly. There is an urgent need to advance practices in helping service-users to make a decision regarding neuroleptic medication that can then be supported by clinicians.
Current interventions regarding medication use predominantly focus on increasing adherence to medication regimes using, for example, financial incentives. This raises ethical concerns over the potential for service users' priorities and preferences to be disregarded, leading to increased coercion and reduced empowerment for service users. The recovery movement emphasises the need to understand personal priorities when considering treatment options and informed choice and shared-decision making is promoted by government initiatives and practice guidelines.
Shared decision-making commonly occurs within physical health settings. Patient decision aids have been found to improve patients' knowledge of available options and help patients to have more accurate expectations of potential benefits and harms, reach choices that are more consistent with personal values and participate in decision making. Despite this, shared-decision making has not been adopted more widely and is particularly poor within mental health settings.
The current study aims to explore the feasibility and acceptability of an intervention aimed at helping service users in mental health services think about their own personal priorities and decision-making around medication use. Current psychological interventions, such as cognitive behavioural therapy (CBT) and motivational interviewing (MI), view decision-making in terms of individuals making cost-benefit analyses, which then informs their "planned" behaviour. Such interventions thus target the identification of desirable medication related behaviours and then help the individual to make those behaviours occur.
Perceptual Control Theory (PCT) offers an alternative framework in which to understand medication related decision-making and behaviour. PCT regards all behaviour as goal directed but states that individuals control their experiences (or input) not their behaviour (or output). From this perspective, behaviour is understood as a means by which an individual resolves discrepancies between how they currently experience something (a current perception) and the way they want that experience to be. There is recognition that people are usually unaware of many of the different priorities (or goals) they hold, although these priorities/ goals are often incompatible (in conflict). An intervention informed by PCT (Method of Levels; MOL) would, therefore, target increasing an individual's awareness of the different personal priorities/ goals they hold in relation to medication use. The intervention would focus on exploring conflict between personal priorities, as from a PCT perspective; conflict is what causes ambivalence or difficulties in being able to enact certain planned behaviours. The aim in the current study would be to use MOL to help people develop their awareness of what is important to them in relation to medication use, as opposed to focusing on planning specific behaviours.
The aim in the current study would be to use MOL to help people explore their decision around the use of neuroleptic medication. Traditionally the focus of a MOL session is determined by the client and can vary from person to person, however, for this study the sessions will be specifically focused on neuroleptic medication use. The sessions will aim to help people explore a range of thoughts and feelings about decisions around medication use and how these relate to other important life values and goals. Another key aim of sessions will be to help people develop awareness of conflicts in their goals so that they might begin to find potential resolution. Due to the nature of the intervention being very patient-led and idiosyncratic, the outcome will vary from person to person. The intervention does not attempt to increase adherence or encourage discontinuation to the neuroleptic medication. It aims to help people develop awareness of how they feel about using neuroleptic medication and how medication might relate to other things that are important to them in life.
If this is a feasible and acceptable approach to use then future research would explore whether prescribers could incorporate this approach to working in their consultations with service users.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Method of Levels | Other | Other: Method of LevelsTalking therapy- duration and frequency of sessions to be determined by participant |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Over 16 years of age
- Capacity to provide informed written consent
- Able to converse in English proficiently
- Currently under the care of an Early Intervention Service or Community Mental Health Team
- Ambivalent around medication use
Key exclusion criteria (3 listed)
- If currently experiencing such a deterioration in mental state that they may have difficulties making decisions in their life
- If significant risk of harm to self or others is present
- If there is an organic basis for psychosis
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 |
|---|---|---|
| Method of LevelsTalking Therapy | Other | Method of Levels |
Primary outcome
Number of participants recruited to the study
Time frame: through study completion, an average of 5 months.
Number of participants recruited to the study
Number of participants retained during the study
Time frame: through study completion, an average of 5 months.
Number of participants retained during the study
Change in therapeutic alliance from baseline to 12 weeks
Time frame: baseline, 12 weeks.
The Session Rating Scale is a brief therapeutic alliance measure designed for every session clinical use. The SRS is a four-item visual analogue instrument that explores the relationship, goals and topics, approach or method, and how the client perceives the session in total. Scores range between 0 and 40, higher scores suggest better therapeutic alliance.
5 secondary outcomes
Change in treatment-related empowerment from baseline to 12 weeks
Time frame: baseline, 12 weeks.
Change in attitude towards medication from baseline to 12 weeks
Time frame: baseline, 12 weeks.
Change in compliance to medication regime from baseline to 12 weeks
Time frame: baseline, 12 weeks.
Change in personal recovery from baseline to 12 weeks
Time frame: baseline, 12 weeks.
Change in engagement with services from baseline to 12 weeks
Time frame: baseline, 12 weeks.
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 21 May 2019.
- Background: PubMed 16774655Moncrieff J. Does antipsychotic withdrawal provoke psychosis? Review of the literature on rapid onset psychosis (supersensitivity psychosis) and withdrawal-related relapse. Acta Psychiatr Scand. 2006 Jul;114(1):3-13. doi: 10.1111/j.1600-0447.2006.00787.x.
- Background: PubMed 19341533Mansell W, Carey TA. A century of psychology and psychotherapy: is an understanding of 'control' the missing link between theory, research, and practice? Psychol Psychother. 2009 Sep;82(Pt 3):337-53. doi: 10.1348/147608309X432526. Epub 2009 Apr 1.
- Individual participant dataSharing planned: Yes. Annoymous data files for outcome data will be shared on request
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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.
Sara Tai principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Method of Levels in people with Psychosis and Medication Adherence, run by University of Manchester at 2 sites in United Kingdom.
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 7 inclusion and 3 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 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of participants recruited to the study (time frame: through study completion, an average of 5 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03537040, which also lists 2 linked publications.
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 21 May 2019.