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An Acceptance-Based Behavioral Intervention vs. Nutritional Counselling for Weight Loss in Psychotic Illness

NCT ID: NCT02130596

Last Updated: 2014-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-10-31

Brief Summary

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Obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. The risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. Traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. This pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. This is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. The results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time.

Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.

Detailed Description

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Conditions

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Psychotic Illnesses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acceptance-Based Behavioral Intervention

Group Type EXPERIMENTAL

Acceptance-Based Behavioral Intervention

Intervention Type BEHAVIORAL

Nutritional Counselling

Group Type ACTIVE_COMPARATOR

Nutritional Counselling

Intervention Type OTHER

Interventions

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Acceptance-Based Behavioral Intervention

Intervention Type BEHAVIORAL

Nutritional Counselling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \> 25.0
* Diagnosed psychotic illness (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, and psychotic disorder not otherwise specified).

Exclusion Criteria

* Inability to provide informed consent
* Prediabetes or type 2 diabetes mellitus
* Current enrollment in another formal weight management program
* Brief Psychiatric Rating Scale (BPRS) ratings of 4 or more on any one of Grandiosity (Item #6), Suspiciousness (Item #7), Hallucinations (Item #8), Unusual Thought Content (Item #9), or Conceptual Disorganization (Item #10), or a BPRS total score of 80 or more.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Rohan Ganguli

Senior Scientist, Canada Research Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rohan Ganguli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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132/2013

Identifier Type: -

Identifier Source: org_study_id