Time Intensive CBT for a Specific Phobia of Vomiting

NCT02920814 | Completed Phase 1

• 1 other identifier: 16/LO/0095
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Specific Phobia of Vomiting; Emetophobia

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (5)

• Emetophobia Questionnaire

  1 week

• Patient Health Questionnaire (PHQ-9)

  1 week

• Generalised Anxiety Disorder (GAD7)

  1 week

• Work and Social Adjustment Scale

  1 week

• IAPT Employment Status Questions

  1 week

Study Arms (1)

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).

Other: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural Therapy OTHER

Time intensive CBT over 8 weeks, including 6 weekly sessions and two intensive days of 4 hours each.

Time Intensive CBT for SPOV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

Centre for Anxiety Disorders and Trauma

London, SE5 8AZ, United Kingdom

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: April 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: December 5, 2018

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)