Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463470
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-30
Brief Title:
Cognitive Behavioural Therapy for AvoidantRestrictive Food Intake Disorder CBT-AR
Sponsor:
Orygen
Organization:
Orygen
Study Overview
Official Title:
Cognitive Behavioural Therapy for AvoidantRestrictive Food Intake Disorder CBT-AR An Evaluation of the Feasibility Acceptability and Effectiveness in Individuals Aged 12 to 25 Years
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBT-AR
Brief Summary:
CBT-AR describes an adaption of cognitive behavioural therapy for use with individuals diagnosed with AvoidantRestrictive Food Intake Disorder ARFID The purpose of this evaluation is to determine the feasibility acceptability and effectiveness of this treatment
It is hypothesised that this treatment will be feasible and acceptable to clinicians carers and patients and will be effective in reducing symptoms of ARFID for patients
It is hypothesised that this treatment will be feasible and acceptable to clinicians carers and patients and will be effective in reducing symptoms of ARFID for patients
Detailed Description:
CBT-AR describes an adaption of cognitive behavioural therapy that is appropriate for use with individuals diagnosed with AvoidantRestrictive Food Intake Disorder ARFID This therapy will be delivered by trained clinicians eg psychologists mental health nurses and involves weekly sessions for 18-30 sessions up to 30 sessions for underweight patients This therapy will be delivered face-to-face whenever possible If required participant not able to travel for a session etc online or telephone sessions will be conducted
This therapy involves four stages as described below
Stage 1 - Psychoeducation This is covered in 2-4 sessions and involves explaining what ARFID is educating patients and carers on food groups nutrition and how to develop a balanced diet Work is also done to increase eating volume for those who are underweight
Stage 2 - Treatment planning This is covered in 2 sessions and involves matching the individuals needs to the correct exposure approach examples provided in stage 3
Stage 3 - Graded exposure is covered for between 12 and 22 sessions depending on the patients needs and describes slowly introducing more variety and volume of foods into the patients diet For those patients who are uncomfortable with strong tastes and textures graded exposure might involve eating very small amounts of new foods during which time they are encouraged to describe the look feel and taste of the food using neutral words to reduce a negative response If they have a fear of choking they might start by talking about that fear followed by watching a video of someone choking and recovering then they might eat a very small amount of food to reduce the risk of choking followed by increases in portions over time
Stage 4 - Relapse prevention This is covered in 2 sessions In these sessions individuals are taught to recognise triggers and indicators of relapse They are then able to go back to the materials provided in treatment to guide their management of these relapsing thoughtsbehaviours
Clinicians will collect data on adherence weekly A measure of patient parentguardian and clinician satisfaction will be collected at the end of stage 4
Parentsguardians of individuals 16yrs or parentsguardians of patients who are underweight and living at home irrespective of age are involved in therapy through attending psychoeducation sessions and supporting the completion of homework
This therapy involves four stages as described below
Stage 1 - Psychoeducation This is covered in 2-4 sessions and involves explaining what ARFID is educating patients and carers on food groups nutrition and how to develop a balanced diet Work is also done to increase eating volume for those who are underweight
Stage 2 - Treatment planning This is covered in 2 sessions and involves matching the individuals needs to the correct exposure approach examples provided in stage 3
Stage 3 - Graded exposure is covered for between 12 and 22 sessions depending on the patients needs and describes slowly introducing more variety and volume of foods into the patients diet For those patients who are uncomfortable with strong tastes and textures graded exposure might involve eating very small amounts of new foods during which time they are encouraged to describe the look feel and taste of the food using neutral words to reduce a negative response If they have a fear of choking they might start by talking about that fear followed by watching a video of someone choking and recovering then they might eat a very small amount of food to reduce the risk of choking followed by increases in portions over time
Stage 4 - Relapse prevention This is covered in 2 sessions In these sessions individuals are taught to recognise triggers and indicators of relapse They are then able to go back to the materials provided in treatment to guide their management of these relapsing thoughtsbehaviours
Clinicians will collect data on adherence weekly A measure of patient parentguardian and clinician satisfaction will be collected at the end of stage 4
Parentsguardians of individuals 16yrs or parentsguardians of patients who are underweight and living at home irrespective of age are involved in therapy through attending psychoeducation sessions and supporting the completion of homework
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None