ISRCTN - ISRCTN01629698: Psychological treatments for problem gambling reseach Study (PROGRESS)

Plain English Summary

Background and study aims
The DSM IV (American Psychiatric Association, 2000) defines pathological gambling as 'Persistent and recurrent maladaptive gambling behavior' with at least 5 out of 10 associated criteria required to be attained in order to merit the diagnosis. In the US, problem gambling is often considered to be a sub-clinical form of pathological gambling but in many other jurisdictions, the term 'problem gambling' (PG) is used to encompass all people with a significant gambling problem. Problem gambling often has important health and social consequences for those who have it. Divorce rates are high, family violence and relationship problems generally are more common. Bankruptcy rates and participation in criminal activity related to money are also higher amongst this group than in the general community. A recent Cochrane review of the problem gambling treatment literature has found that psychological treatments, such as cognitive behaviour therapy and motivational interviewing, could be helpful in reducing problem gambling. These reviews also identified the current gaps in knowledge about effective treatments for problem gambling and have shown that more research is required to determine which treatment is most effective, and which one works best for whom. The purpose of this study is to investigate the effectiveness of psychological treatments for problem gambling and to determine if the effects can be sustained over time. It will also examine if different types of people respond better to certain types of psychological treatment.

Who can participate?
This study aims to recruit participants aged 18 years and above, wish to receive treatment for their gambling problem and can communicate in the English language. Individuals that are unable to provide informed consent, are at risk of self-harm or are currently receiving other treatments for their gambling problem or have received such treatment in the past 12 months from a counsellor or therapist are not able to participate in this study.

What does the study involve?
Participants will be randomly allocated to one of four treatment arms including cognitive- behavioural therapy, behavioural therapy, motivational interviewing and client-centred therapy. Participants will receive six individual sessions of face-to-face treatment with a psychologist. Information relating to the participants gambling activities, psychological profile and wellbeing will be collected immediately before and after treatment and at 6, 12, 18 and 24 months after the completion of treatment using telephone interviews.

What are the possible benefits and risks of participating?
Participants will receive free treatment for their gambling problems. The information obtained from this study may benefit people seeking help for their gambling problems in the future by informing treatment providers of effective interventions. The main risk involved in taking part in this study is possible distress associated with receiving any psychological intervention for a disorder of this kind.

Where is the study run from?
This study is being conducted by the Problem Gambling Research and Treatment Centre, a joint initiative of Monash University and the University of Melbourne. The study is led by Monash University Problem Gambling Research and Treatment Centre.

When is the study starting and how long is it expected to run for?
The study has commenced in August 2012 and recruitment will occur until June 2013. Post intervention data will conclude in June 2015.

Who is funding the study?
Funding has been provided by the Victorian Department of Justice.

Who is the main contact?
Professor Shane Thomas
shane.thomas@monash.edu

Trial website

http://www.med.monash.edu.au/pgstudy

Contact information

Type

Scientific

Primary contact

Prof Shane Thomas

ORCID ID

Contact details

Monash University
Problem Gambling Research and Treatment Centre
270 Ferntree Gully Road
Notting Hill
3168
Australia
+61 (0)399024510
Shane.Thomas@monash.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial to determine effective psychological treatments for problem gambling

Acronym

PROGRESS

Study hypothesis

To determine the effectiveness of manualised cognitive-behavioural therapy, behavioural therapy, client-centred therapy and motivational interviewing interventions in reducing gambling activity and gambling symptom severity immediately after treatment and up to 2 years follow-up.

Updated 26/08/2015:
Overall trial duration has been updated from 01/08/2012 - 01/06/2015 to 01/01/2013 - 01/12/2015. Overall recruitment duration has been updated from 01/08/2012 - 01/06/2015 to 01/01/2013 - 01/02/2014.

Ethics approval

1. Victorian Department of Justice Human Research Ethics Committee, 07/12/2011, ref: CF/11/22687
2. Monash University Human Research Ethics Committee, 20/12/2011, ref: CF11/3707 - 2011001954
3. University of Melbourne Central Human Research Ethics Committee, 06/02/2012, ref: 1237304

Study design

Parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Patient information material can be found at http://www.med.monash.edu.au/sphc/pgrtc/rct/index.html

Condition

Pathological and problem gambling

Intervention

Participants will be randomly allocated to one of four interventions. Each of the interventions will consist of six individual sessions of psychological treatment. The interventions will be manualised to maximise compliance and consistency of treatment.

The interventions are:
1. Cognitive-behavioural therapy
2. Behavioural therapy
3. Motivational interviewing
4. Client-centred therapy

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Gambling symptom severity
2. Gambling behaviour:
2.1. Frequency
2.2. Time spent gambling
2.3. Amount spent gambling

Secondary outcome measures

1. Gambling related cognitions
2. Psychological distress
3. Depression
4. Anxiety
5. Alcohol and substance use
6. Gambling related debt and financial problems

Overall trial start date

01/01/2013

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Wish to receive treatment for their gambling problem
3. Can communicate in the English language

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

276

Participant exclusion criteria

1. Unable to understand and provide informed consent
2. Currently receiving other treatments for their gambling problems or have received such treatment in the past 12 months from a counsellor or therapist
3. At risk of self-harm

Recruitment start date

01/01/2013

Recruitment end date

01/02/2014

Locations

Countries of recruitment

Australia

Trial participating centre

Monash University
Notting Hill
3168
Australia

Sponsor information

Organisation

Monash University (Australia)

Sponsor details

Problem Gambling Research and Treatment Centre
270 Ferntree Gully Road
Notting Hill
3168
Australia
+61 (0)419560131
shane.thomas@monash.edu