Specific Phobia of VomitingPhase 1NCT02920814
Time Intensive CBT for a Specific Phobia of Vomiting
A Phase 1 study testing Cognitive Behavioural Therapy in people with Specific Phobia of Vomiting and Emetophobia, run by King's College London at 1 site in United Kingdom.
Trial summary
The aims of this project are to determine the effectiveness of a time intensive form of Cognitive Behavioural Therapy (CBT) for Specific Phobia of Vomiting (SPOV). Current research shows that this brief format can be effective in other specific phobias e.g. insects and animals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specific Phobia of Vomiting, Emetophobia
- What is being tested?
- Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to 30 Aug 2018
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or over with a diagnosis of SPOV as defined by DSM-5
- The individual describes the SPOV as their main psychological problem
- The individual is able to read materials written in English and answer written questions
- Individuals must have capacity to provide written informed consent
Who cannot join
- Involvement in active CBT (imagery rescripting and/or exposure) within 2 years or inactive CBT within 1 year previous to this study
- Individuals with a diagnosis of any other mental health disorder that required treatment in its own right
- Individuals currently taking anti-anxiolytic medication where the dose has not been stable over one month prior to entering the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Anxiety Disorders and Trauma
London, SE5 8AZ
About this study
Official title: Time Intensive Cognitive Behavioural Therapy for a Specific Phobia of Vomiting Using a Single Case Experimental Design
The aims of this project are to determine the effectiveness of a time intensive form of Cognitive Behavioural Therapy (CBT) for Specific Phobia of Vomiting (SPOV). Current research shows that this brief format can be effective in other specific phobias e.g. insects and animals. However, to date limited research has been conducted on the effectiveness of time intensive forms of CBT for SPOV. A single case experimental design will be used to analyse specific and idiosyncratic outcome measures in 6-8 cases of SPOV, referred to the Centre for Anxiety Disorders and Trauma (CADAT) for treatment. Specifically, the project will explore the effectiveness of CBT delivered in a time-intensive format and imagery rescripting elements of the treatment. This initial study will provide important information about which elements of CBT are most effective at reducing targeted symptoms and whether symptom reduction can be achieved in a shorter number of sessions. It represents a crucial step before this format of CBT can be more rigorously evaluated and compared to other treatment approaches by Randomised Controlled Trial.
Read the detailed description
Design A single case experimental design (ABACADA) will be used. A, B, C etc represents points of intervention and clinical contact with participants when standardised outcome measures will be administered by the treating clinician at each session. Phases A1, A2, A3 represent time between contact during which participants will undertake daily monitoring of idiosyncratic symptoms on Visual Analogue Scales (VAS) e.g. degree of avoidance, degree of worry, degree of nausea etc, so change between phases across time can be measured.
Participants will be randomly allocated to differing lengths of baseline phase (initial clinical assessment to first clinical session) with 4 potential arms (7, 10, 14, or 17 days). The first three clinical sessions (formulation, imagery rescripting and planning of intensive days) will take place weekly and last up to 1.5 hours. The two intensive days will last up to 4 hours each and take place shortly after the planning session and within a few days of each other. Three additional follow up sessions will be offered within 10 days of the intensive days (2 within one week, and the final session one week after). Follow up data will be collected by phone or post 3, 6 and 12 months post intervention.
Participants Participants will be recruited from consecutive referrals to CADAT for treatment of SPOV. Clients will have a diagnosis of SPOV as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as their main presenting problem. They will be drawn from the CADAT waiting list, and if necessary from Improving Access to Psychological Therapy (IAPT) services at Southwark, Lambeth and Lewisham. These cases will be picked up by and treated at CADAT by qualified clinicians.
Participants are expected to be involved in the study for up to 8 weeks for the treatment phase, and 12 months for follow up data to be collected.
Recruitment Consultant Psychiatrist for the team at the Centre for Anxiety Disorders and Trauma will identify potential participants from the waiting list at CADAT who meet the inclusion criteria to take part in the study. Potential participants will then be asked if they would like to participate at the initial clinical assessment. They will be provided with an information sheet and the opportunity to ask questions before making a decision and giving informed consent.
Sample size It is estimated that 6-8 cases will be sufficient for a single case experimental design to demonstrate proof of concept. This is based on previous studies using a similar design.
Procedure Patients identified from the CADAT waiting list and who meet the study criteria will be asked at assessment if they would like to participate in the study. Those who are interested in taking part will be given an information sheet, and the opportunity to ask questions before making a decision on their participation. They will then be asked to provide informed written consent by signing a consent form before continuing with the study procedure. Clinicians will remind all participants of their right to withdraw from the study at any time, which will not affect their care or right to treatment as usual. Participants will then receive the time intensive form of CBT for their SPOV.
To ensure therapist adherence to the time intensive format of the treatment, a separate treatment protocol has been provided as part of Standard Operating Procedures. This protocol is as follows:
- Assessment and signing of consent form
- Session 1: Re-baseline \& Formulation (including a conversation about early memory of vomiting)
- Session 2: Imagery Rescripting of early memory of vomiting
- Session 3: Planning for Intensive Days
- Intensive Day 1
- Intensive Day 2
- 3 short clinical follow up sessions
Standardised outcome measures will be collected at baseline, intervention and follow up phases. Participants will also be asked to collect daily idiosyncratic measures in between the intervention phases. Participants will be randomly allocated to differing lengths of baseline to the time of the intervention with 4 potential arms (7 days, 10 days 14 days or 17 days). This will be done using a simple spreadsheet by a Research Assistant at CADAT. The baseline discussion around the memory of vomiting, imagery re-scripting and treatment planning will consist of 1-1.5 hour sessions. Time intensive treatment will consist of two sessions over 2 days (4 hours each). Three additional follow up sessions will be administered, 2 within 1 week of the intensive days and a third 1 week after the second follow up session. The same standardised outcome measures will be collected at 3, 6 and 12 months by phone or post.
- Conditions
- Specific Phobia of Vomiting, Emetophobia
- Being tested
- Cognitive Behavioural Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyOther
Time intensive CBT over 8 weeks, including 6 weekly sessions and two intensive days of 4 hours each.
| Study group | Role | What they receive |
|---|---|---|
| Time Intensive CBT for SPOV | Experimental | Time intensive CBT for SPOV involving 6 weekly sessions and 2 intensive days of 4 hours each (over 8 weeks in total). Receives: Other: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Phobia of Vomiting Inventory (SPOVI)
A 14-item self-report measure that focuses on cognitive processes, safety seeking and avoidance behaviours (Veale et al, 2013). The total score ranges from 0 to 56. The scale has a two-factor structure, with one factor of 7 items characterized by avoidance (e.g. "I have been trying to avoid or control any thoughts or images about vomiting") and a second factor of 7 items comprised of threat monitoring (e.g. "I have been focused on whether I feel ill and could vomit rather than on my surroundings"). Cronbach's α is .91.
Measured: 1 week
Secondary outcomes (5)
Emetophobia Questionnaire
13-item self-report questionnaire that has good reliability and validity against a behavioural avoidance test (Boschen \& Riddel, unpublished observations). The range is 13-65. The EmetQ has 3 factors. Factor 1 had 6 items focused on avoidance of travel, movement, or locations. Factor II was comprised of 3 items, which centred on themes of dangerousness of exposure to vomit stimuli. Factor III consisted of 4 items that focus on avoidance of others who may vomit. Cronbach's α is 0.82.
Measured: 1 week
Patient Health Questionnaire (PHQ-9)
9-item measure of depressive symptoms, based on DSM-IV. The total score ranges from 0 to 27 and Cronbach's α was .86.
Measured: 1 week
Generalised Anxiety Disorder (GAD7)
7-item scale and is designed to measure the severity of symptoms of generalized anxiety disorder. The total score ranges from 0 to 21 and the Cronbach's α was 0.92.
Measured: 1 week
Work and Social Adjustment Scale
5 item scale that is designed to measure interference in life.
Measured: 1 week
IAPT Employment Status Questions
Questions relating to current employment status, Statutory Sick Pay and benefits.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startApr 2016
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Phobia of VomitingStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920814
- Sponsor's protocol ID
- 16/LO/0095
- Status last verified
- Apr 2016
- First submitted
- 29 Sep 2016
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Intensive Cognitive Behavioural Therapy for a Specific Phobia of Vomiting Using a Single Case Experimental Design
- ClinicalTrials.gov ID
- NCT02920814
- Acronym / sponsor ID
- 16/LO/0095
- Conditions
- Specific Phobia of Vomiting, Emetophobia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- Apr 2016
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 30 Sep 2016 (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 aims of this project are to determine the effectiveness of a time intensive form of Cognitive Behavioural Therapy (CBT) for Specific Phobia of Vomiting (SPOV). Current research shows that this brief format can be effective in other specific phobias e.g. insects and animals. However, to date limited research has been conducted on the effectiveness of time intensive forms of CBT for SPOV. A single case experimental design will be used to analyse specific and idiosyncratic outcome measures in 6-8 cases of SPOV, referred to the Centre for Anxiety Disorders and Trauma (CADAT) for treatment. Specifically, the project will explore the effectiveness of CBT delivered in a time-intensive format and imagery rescripting elements of the treatment. This initial study will provide important information about which elements of CBT are most effective at reducing targeted symptoms and whether symptom reduction can be achieved in a shorter number of sessions. It represents a crucial step before this format of CBT can be more rigorously evaluated and compared to other treatment approaches by Randomised Controlled Trial.
Detailed description
Design A single case experimental design (ABACADA) will be used. A, B, C etc represents points of intervention and clinical contact with participants when standardised outcome measures will be administered by the treating clinician at each session. Phases A1, A2, A3 represent time between contact during which participants will undertake daily monitoring of idiosyncratic symptoms on Visual Analogue Scales (VAS) e.g. degree of avoidance, degree of worry, degree of nausea etc, so change between phases across time can be measured.
Participants will be randomly allocated to differing lengths of baseline phase (initial clinical assessment to first clinical session) with 4 potential arms (7, 10, 14, or 17 days). The first three clinical sessions (formulation, imagery rescripting and planning of intensive days) will take place weekly and last up to 1.5 hours. The two intensive days will last up to 4 hours each and take place shortly after the planning session and within a few days of each other. Three additional follow up sessions will be offered within 10 days of the intensive days (2 within one week, and the final session one week after). Follow up data will be collected by phone or post 3, 6 and 12 months post intervention.
Participants Participants will be recruited from consecutive referrals to CADAT for treatment of SPOV. Clients will have a diagnosis of SPOV as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as their main presenting problem. They will be drawn from the CADAT waiting list, and if necessary from Improving Access to Psychological Therapy (IAPT) services at Southwark, Lambeth and Lewisham. These cases will be picked up by and treated at CADAT by qualified clinicians.
Participants are expected to be involved in the study for up to 8 weeks for the treatment phase, and 12 months for follow up data to be collected.
Recruitment Consultant Psychiatrist for the team at the Centre for Anxiety Disorders and Trauma will identify potential participants from the waiting list at CADAT who meet the inclusion criteria to take part in the study. Potential participants will then be asked if they would like to participate at the initial clinical assessment. They will be provided with an information sheet and the opportunity to ask questions before making a decision and giving informed consent.
Sample size It is estimated that 6-8 cases will be sufficient for a single case experimental design to demonstrate proof of concept. This is based on previous studies using a similar design.
Procedure Patients identified from the CADAT waiting list and who meet the study criteria will be asked at assessment if they would like to participate in the study. Those who are interested in taking part will be given an information sheet, and the opportunity to ask questions before making a decision on their participation. They will then be asked to provide informed written consent by signing a consent form before continuing with the study procedure. Clinicians will remind all participants of their right to withdraw from the study at any time, which will not affect their care or right to treatment as usual. Participants will then receive the time intensive form of CBT for their SPOV.
To ensure therapist adherence to the time intensive format of the treatment, a separate treatment protocol has been provided as part of Standard Operating Procedures. This protocol is as follows:
- Assessment and signing of consent form
- Session 1: Re-baseline \& Formulation (including a conversation about early memory of vomiting)
- Session 2: Imagery Rescripting of early memory of vomiting
- Session 3: Planning for Intensive Days
- Intensive Day 1
- Intensive Day 2
- 3 short clinical follow up sessions
Standardised outcome measures will be collected at baseline, intervention and follow up phases. Participants will also be asked to collect daily idiosyncratic measures in between the intervention phases. Participants will be randomly allocated to differing lengths of baseline to the time of the intervention with 4 potential arms (7 days, 10 days 14 days or 17 days). This will be done using a simple spreadsheet by a Research Assistant at CADAT. The baseline discussion around the memory of vomiting, imagery re-scripting and treatment planning will consist of 1-1.5 hour sessions. Time intensive treatment will consist of two sessions over 2 days (4 hours each). Three additional follow up sessions will be administered, 2 within 1 week of the intensive days and a third 1 week after the second follow up session. The same standardised outcome measures will be collected at 3, 6 and 12 months by phone or post.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time Intensive CBT for SPOV | Experimental | Other: Cognitive Behavioural TherapyTime intensive CBT for SPOV involving 6 weekly sessions and 2 intensive days of 4 hours each (over 8 weeks in total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or over with a diagnosis of SPOV as defined by DSM-5
- The individual describes the SPOV as their main psychological problem
- The individual is able to read materials written in English and answer written questions
- Individuals must have capacity to provide written informed consent
Key exclusion criteria (3 listed)
- Involvement in active CBT (imagery rescripting and/or exposure) within 2 years or inactive CBT within 1 year previous to this study
- Individuals with a diagnosis of any other mental health disorder that required treatment in its own right
- Individuals currently taking anti-anxiolytic medication where the dose has not been stable over one month prior to entering the study
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 |
|---|---|---|
| Cognitive Behavioural TherapyTime intensive CBT over 8 weeks, including 6 weekly sessions and two intensive days of 4 hours each. | Other | Time Intensive CBT for SPOV |
Primary outcome
Specific Phobia of Vomiting Inventory (SPOVI)
Time frame: 1 week
A 14-item self-report measure that focuses on cognitive processes, safety seeking and avoidance behaviours (Veale et al, 2013). The total score ranges from 0 to 56. The scale has a two-factor structure, with one factor of 7 items characterized by avoidance (e.g. "I have been trying to avoid or control any thoughts or images about vomiting") and a second factor of 7 items comprised of threat monitoring (e.g. "I have been focused on whether I feel ill and could vomit rather than on my surroundings"). Cronbach's α is .91.
5 secondary outcomes
Emetophobia Questionnaire
Time frame: 1 week
Patient Health Questionnaire (PHQ-9)
Time frame: 1 week
Generalised Anxiety Disorder (GAD7)
Time frame: 1 week
Work and Social Adjustment Scale
Time frame: 1 week
IAPT Employment Status Questions
Time frame: 1 week
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 5 Dec 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive Behavioural Therapy in people with Specific Phobia of Vomiting and Emetophobia, run by King's College London at 1 site 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 4 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Specific Phobia of Vomiting Inventory (SPOVI) (time frame: 1 week). 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 5 Dec 2018.