Gambling ProblemNCT04609007
The Effect of a Brief Intervention for Problem Gamblers
A study testing Cognitive behavioral therapy (CBT) and Regular help-line telephone counselling in people with Gambling Problem, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT). Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Problem
- What is being tested?
- Cognitive behavioral therapy (CBT) and Regular help-line telephone counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2015to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Experiencing gambling problems (PGSI ≥ 3 p)
- Good enough knowledge in Swedish
- Access to a smart phone or computer with internet connection
Who cannot join
- Being involved in another treatment study the previous 3 months
- Other concurrent treatment for gambling problems
- Being on a non-stable pharmacological treatment for any psychiatric condition
- Severe depression defined as a PHQ-9 score of 20 points or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled
A pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT). Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.
Read the detailed description
The current study is a pragmatic randomized pilot trial examining the feasibility and effects of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT) . Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.
Participants will be recruited via the Swedish national gambling helpline. After assessment for eligibility participants will be randomized, using block randomization to ensure balanced groups, to either TAU or TAU+CBT.
The participants will be measured; at baseline, weekly during the intervention (6 weeks), immediately after the intervention and at 6 weeks after treatment termination. Informed consent will be collected prior any data collection.
- Conditions
- Gambling Problem
- Being tested
- Cognitive behavioral therapy (CBT), Regular help-line telephone counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
A brief 4 sessions online CBT program with therapist support.
Regular help-line telephone counsellingBehavioural
A single session of telephone counselling with a help-line counsellor
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | The TAU condition consists of a single session of regular help-line telephone counselling Receives: Behavioral: Regular help-line telephone counselling |
| Cognitive behavioral therapy | Experimental | The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions. Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention at the end of the study
Retention, defined as proportion of participants who fill out the last follow-up survey
Measured: 6-weeks after the intervention
Time for execution of the study
Time for execution of the study as measured by the time from the first included participant to the last included,
Measured: from the date of the first included participant to the last included, assessed up to 52 weeks
Participant rated satisfaction with the treatment protocol
Participant rated satisfaction with the treatment protocol will be measured using three items at the end of each online treatment module. The items are measured on a VAS scale ranging from 1-5 (1= not at all, 5 = very).
Item 1) "How helpful do you think the content of this module has been?" Item 2) "How well does the content of the module fit the problems you experience and want help with?" Item 3) "What grade from 1 to 5 would you give this module?
Measured: measured in conjunction with each online treatment module for up to six weeks (at four occasions)
Participant rated satisfaction with the treatment at large
Participant rated satisfaction with the treatment at large will be measured immediately after the intervention using 12 items on a VAS scale ranging from 1 (not at all) to 10 (very). Item 8 answers "yes" or "no" and item 9 is a free-text entry only available if item 8 answers "yes". Items 1- 4 and items 10-12 captures satisfaction with the program and items 5 - 9 captures satisfaction with the therapist.
Measured: immediately after the intervention.
Secondary outcomes (11)
Timeline follow-back, days gambling and net losses due to gambling
A calendar function where gamblers registers days gambling and nett losses due to gambling.
Measured: At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up
Problem Gambling Severity Index (PGSI)
An instrument measuring level of gambling problems using 9 items on a 4 levels Likert-scale, 0 p (never) to 3 p (always), with a total score ranging from 0 to 27 p. Scoring 5 points or more indicates problem gambling.
Measured: At baseline and at the 6-weeks follow-up
National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)
An instrument measuring measuring gambling disorder. The instrument consists of 17 items which are market "yes" or "no" and yields a total score of 10 points. Five points or more indicates a pathological gambler.
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
Alcohol Use Disorders Identification Consumption (AUDIT-C)
An instrument which measures alcohol consumption in the general population. The instrument consists of 3 questions ranging from 0 to 4 with a total score of 0-12 points. A total score of ≥ 6 p indicates alcohol problems in men and ≥ 4 p in women
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
Drug Use Disorders Identification Test Consumption (DUDIT-C)
An instrument consisting of 3 items measuring illicit drug consumption.
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
Generalised Anxiety Disorder 7-item scale (GAD-7)
An instrument measuring anxiety consisting of 7 items with a total score ranging from 0 to 21 points where 15 or more points indicates severe anxiety.
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
Gambling Abstinence Self-Efficacy Scale (GASS)
An instrument measuring self efficacy in gambling situations. The instrument consists of 21 items scored 0 to 5 points, yielding a total score of 0 - 105 points.
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
Gambling Urges Scale (GUS)
An instrument measuring gambling urges. The instrument consists of 6 items on a Likert-scale 0 to 7, yielding a total score ranging from 0 - 42 points. A higher total score indicates more gambling urges.
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
Consumption Screen for Problematic Gambling (CSPG)
An instrument measuring consumption of gambling the previous year. The instrument consists of three items yielding a total score ranging from 0-13 points. Four or more points indicates gambling problems
Measured: At baseline
Patient Health Questionnaire-9 (PHQ-9)
A nine items instrument measuring depression ranging from 0 to 27 points. Twenty points or more indicates severe depression
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
World Health Organization Quality of Life Instruments (WHOQOL-BREF)
A 26 items instrument developed by the World Health Organisation measuring quality of life. Items are scored 1-5 points, yielding a total score ranging from 26 - 130 p.
Measured: At baseline, immediately after the intervention and at the 6-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study startMar 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gambling ProblemStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Hellner Gumpert, Karolinska Institutet
- Investigators
- Clara Hellner, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609007
- Sponsor's protocol ID
- 2017/1063-31
- Status last verified
- Oct 2020
- First submitted
- 30 Aug 2018
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wall H, Magnusson K, Hellner C, Andersson G, Jayaram-Lindstrom N, Rosendahl I. The evaluation of a brief ICBT program with therapist support for individuals with gambling problems in the context of a gambling helpline: a randomized pilot trial. Pilot Feasibility Stud. 2023 Feb 17;9(1):26. doi: 10.1186/s40814-023-01257-7.
PubMed 36805024
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled
- ClinicalTrials.gov ID
- NCT04609007
- Acronym / sponsor ID
- 2017/1063-31
- Conditions
- Gambling Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT). Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.
Detailed description
The current study is a pragmatic randomized pilot trial examining the feasibility and effects of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT) . Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.
Participants will be recruited via the Swedish national gambling helpline. After assessment for eligibility participants will be randomized, using block randomization to ensure balanced groups, to either TAU or TAU+CBT.
The participants will be measured; at baseline, weekly during the intervention (6 weeks), immediately after the intervention and at 6 weeks after treatment termination. Informed consent will be collected prior any data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Regular help-line telephone counsellingThe TAU condition consists of a single session of regular help-line telephone counselling |
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapy (CBT)The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years
- Experiencing gambling problems (PGSI ≥ 3 p)
- Good enough knowledge in Swedish
- Access to a smart phone or computer with internet connection
Key exclusion criteria (4 listed)
- Being involved in another treatment study the previous 3 months
- Other concurrent treatment for gambling problems
- Being on a non-stable pharmacological treatment for any psychiatric condition
- Severe depression defined as a PHQ-9 score of 20 points or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy (CBT)A brief 4 sessions online CBT program with therapist support. | Behavioural | Cognitive behavioral therapy |
| Regular help-line telephone counsellingA single session of telephone counselling with a help-line counsellor | Behavioural | Treatment as usual |
Primary outcome
Retention at the end of the study
Time frame: 6-weeks after the intervention
Retention, defined as proportion of participants who fill out the last follow-up survey
Time for execution of the study
Time frame: from the date of the first included participant to the last included, assessed up to 52 weeks
Time for execution of the study as measured by the time from the first included participant to the last included,
Participant rated satisfaction with the treatment protocol
Time frame: measured in conjunction with each online treatment module for up to six weeks (at four occasions)
Participant rated satisfaction with the treatment protocol will be measured using three items at the end of each online treatment module. The items are measured on a VAS scale ranging from 1-5 (1= not at all, 5 = very). Item 1) "How helpful do you think the content of this module has been?" Item 2) "How well does the content of the module fit the problems you experience and want help with?" Item 3) "What grade from 1 to 5 would you give this module?
Participant rated satisfaction with the treatment at large
Time frame: immediately after the intervention.
Participant rated satisfaction with the treatment at large will be measured immediately after the intervention using 12 items on a VAS scale ranging from 1 (not at all) to 10 (very). Item 8 answers "yes" or "no" and item 9 is a free-text entry only available if item 8 answers "yes". Items 1- 4 and items 10-12 captures satisfaction with the program and items 5 - 9 captures satisfaction with the therapist.
11 secondary outcomes
Timeline follow-back, days gambling and net losses due to gambling
Time frame: At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up
Problem Gambling Severity Index (PGSI)
Time frame: At baseline and at the 6-weeks follow-up
National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Alcohol Use Disorders Identification Consumption (AUDIT-C)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Drug Use Disorders Identification Test Consumption (DUDIT-C)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Gambling Abstinence Self-Efficacy Scale (GASS)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Gambling Urges Scale (GUS)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Consumption Screen for Problematic Gambling (CSPG)
Time frame: At baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 36805024Wall H, Magnusson K, Hellner C, Andersson G, Jayaram-Lindstrom N, Rosendahl I. The evaluation of a brief ICBT program with therapist support for individuals with gambling problems in the context of a gambling helpline: a randomized pilot trial. Pilot Feasibility Stud. 2023 Feb 17;9(1):26. doi: 10.1186/s40814-023-01257-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Hellner, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) and Regular help-line telephone counselling in people with Gambling Problem, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention at the end of the study (time frame: 6-weeks after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.