Group cognitive remediation therapy for adults with obesity prior to behavioural weight loss treatment: study protocol for a randomised controlled superiority study (CRT study)

Anja Hilbert; Marie Blume; David Petroff; Petra Neuhaus; Evelyn Smith; Phillipa J Hay; Claudia Hübner

doi:10.1136/bmjopen-2018-022616

Group cognitive remediation therapy for adults with obesity prior to behavioural weight loss treatment: study protocol for a randomised controlled superiority study (CRT study)

BMJ Open. 2018 Sep 17;8(9):e022616. doi: 10.1136/bmjopen-2018-022616.

Authors

Anja Hilbert¹, Marie Blume¹, David Petroff^{1

2}, Petra Neuhaus², Evelyn Smith^{3

4}, Phillipa J Hay⁴, Claudia Hübner¹

Affiliations

¹ Integrated Research and Treatment Centre AdiposityDiseases, Department of Medical Psychology and Medical Sociology, Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig Medical Center, Leipzig, Germany.
² Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany.
³ School of Social Sciences and Psychology, Western Sydney University, Sydney, New South Wales, Australia.
⁴ Translational Health Research Institute, Western Sydney University, Sydney, New South Wales, Australia.

Abstract

Introduction: Individuals with obesity show deficits in executive functioning which have been implicated in decreased weight loss outcome. Preliminary evidence suggests that cognitive remediation therapy (CRT) improves executive functioning and weight loss in obesity. However, confirmatory support, especially for pre-weight loss use, is lacking. The CRT study aims at determining the efficacy of CRT versus no treatment control in patients with obesity before entering behavioural weight loss (BWL) treatment. It is hypothesised that individuals who receive CRT will show better weight loss outcome, improved executive functioning, greater weight loss-related behavioural changes and higher attendance of BWL treatment, 6 and 12 months after cessation of CRT.

Methods and analysis: In a single-centre, assessor-blinded, randomised, two-armed parallel-group superiority trial, 260 adults with body mass index ≥35.0 kg/m² are centrally randomised to 8-week group-based CRT versus no treatment, before entering BWL treatment. Primary outcome is the amount of weight loss (%) at 6-month follow-up, compared with pre-treatment, derived from measured body weight. Secondary outcomes include improvement in executive functioning post-treatment and in weight loss-related behaviour, mental and physical health, and attendance to BWL treatment at 6-month and 12-month follow-up. Maintenance of weight loss at 12-month follow-up will be determined. Mixed model analyses based on intent-to-treat will be used to compare the CRT and control groups with respect to differences in weight change between pre-treatment and 6-month follow-up. Similar models will be used for analysing 12-month follow-up data and secondary outcomes. Further analyses will include additional covariates to identify predictors of treatment outcome.

Ethics and dissemination: The study was approved by the Ethical Committee of the University of Leipzig (256-15-13072015, version 'Final 1.0 from 28 May 2015). The study results will be disseminated through peer-reviewed publications.

Trial registration number: DRKS00009333; Pre-results.

Keywords: clinical trials; mental health.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cognitive Behavioral Therapy
Cognitive Remediation*
Equivalence Trials as Topic
Executive Function
Health Behavior
Humans
Obesity / psychology
Obesity / therapy*
Patient Compliance
Psychotherapy, Group / methods
Research Design
Single-Blind Method
Weight Loss*
Weight Reduction Programs*

Associated data

DRKS/DRKS00009333