A randomised controlled trial of cognitive remediation therapy for the obese - a preliminary investigatio

Recruiting

• Conditions: obesity; depression; emotion regulation; habitual cluster behaviours; health literacy; executive function; Diet and Nutrition - Obesity; Mental Health - Depression

• Registration Number: ACTRN12613000537752
• Lead Sponsor: niversity of Western Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Inclusion criteria for this group are: having a BMI > 30, age 18- 55 years, current weight under 180 kgs, ability to consent and having completed 10 years of education in English. Participants who are depressed and wish to take part of the trial will be included. Patients with hypertension (medicated or not medicated), type 2 diabetes, or high cholesterol will be included. Those with binge eating disorder will not be excluded. We aim for equal number of females and males, but based on past weight loss studies, ~60% will be females.

Exclusion Criteria

Participants will be excluded if they have a history of psychosis, head injury, neurological disorder including degenerative or inflammatory conditions or stroke, ADHD, epilepsy, developmental or intellectual disability, are unable to complete the testing (e.g. due to hearing, vision or language impediment), are on regular sedative or stimulant medication, and/or if they report substance (alcohol or other) regular use/abuse (more than 2 standard drinks 5 times a week). Individuals will also be excluded if they have regular use of sedatives, hypnotics, antipsychotics, anti-cholinergic or cholinergic medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Functioning. Outcome assessed through a neuro-psychological test battery comprising of (a) Rey Complex Figure Test (b) Trail Making Task (c) Wisconsin Card Sorting Task (d) National Adult Reading Test (e) Reward Loss Task (f) BRIEF A and (g) Digit Span subtest of WAIS III[Immediately post completion of all CRT sessions (8 sessions in total) ];weight loss- assessed by digital scales[90 days post CRT]

Secondary Outcome Measures

Name	Time	Method
Depression assessed by the psychometric inventory DASS 21[90 days post CRT];Emotion regulation- assessed by the psychometric inventory DERS[90 days post CRT];Health Literacy- assessed by- Modified version of the Bulimia Mental Health Literacy Questionnaire[90 days post CRT];Habitual Cluster Behaviours- assessed by the (modified) Self-Report Habit Index (SRHI);[90 days post CRT]