Pathological GamblingNCT01381250
Effects of Internet-based Treatment of Pathological Gambling
A study testing cognitive behavior therapy in people with Pathological Gambling, run by Umeå University at 1 site in Sweden.
Trial summary
A trial testing the outcome of an Internet-based treatment of pathological gambling with the hypothesis that there will be improvements both immediately and up to 36 months. It is also hypnotized that treatment response can be predicted from background variables. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteSweden
- Study dates
- May 2004to Jan 2009
- 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
- Pathological gambling according to DSM and having gambled at least once the past month
- Being atleast 18 years old
- Living in Sweden
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction and Treatment Outcome of Internet-based Treatment of Pathological Gambling With Three-year Follow-up
A trial testing the outcome of an Internet-based treatment of pathological gambling with the hypothesis that there will be improvements both immediately and up to 36 months. It is also hypnotized that treatment response can be predicted from background variables.
- Conditions
- Pathological Gambling
- Being tested
- cognitive behavior therapy
- Keywords
- Pathological gambling according to DSM and having gambled at least once the past month., Being atleast 18 years old
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavior therapyBehavioural
The treatment was based on established cognitive behavior therapy methods, as described in self-help books (Hodgins, 2002; Ladouceur \& Lachance, 2006). The text was divided into eight modules and was adapted for Internet use. The first four modules had a motivational interviewing focus and included building motivation for change by letting the participant answer open-ended questions that would evoke talk of change. The participants were encouraged to ask for input from their relatives on different aspects of their gambling. In addition, the first four modules included time line follow-back and mapping of the reasons for gambling. The remaining four modules were based on CBT. Each module included information and exercises and ended with three to eight essay-style questions. Feedback on homework assignments was usually given within 24 hr after participants had sent their answers via e-mail. Once weekly, a telephone call was made by the therapists to each participant.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The treatment was based on established cognitive behavior therapy methods, as described in self-help books (Hodgins, 2002; Ladouceur \& Lachance, 2006). The text was divided into eight modules and was adapted for Internet use. The first four modules had a motivational interviewing focus and included building motivation for change by letting the participant answer open-ended questions that would evoke talk of change. The participants were encouraged to ask for input from their relatives on different aspects of their gambling. In addition, the first four modules included time line follow-back and mapping of the reasons for gambling. The remaining four modules were based on CBT. Each module included information and exercises and ended with three to eight essay-style questions. Feedback on homework assignments was usually given within 24 hr after participants had sent their answers via e-mail. Once weekly, a telephone call was made by the therapists to each participant. Receives: Behavioral: cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
Measured: 1 month
Secondary outcomes (2)
Hospital Anxiety and Depression Scale
Measured: 1 week
Quality of Life Inventory
Measured: Present moment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMay 2004
- Primary completionJan 2006
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Investigators
- Per Carlbring, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381250
- Sponsor's protocol ID
- Spelstudie2
- Status last verified
- Jan 2004
- First submitted
- 22 Jun 2011
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Treatment Outcome of Internet-based Treatment of Pathological Gambling With Three-year Follow-up
- ClinicalTrials.gov ID
- NCT01381250
- Acronym / sponsor ID
- Spelstudie2
- Conditions
- Pathological Gambling
- Keywords
- Pathological gambling according to DSM and having gambled at least once the past month., Being atleast 18 years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- May 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Jun 2011 (estimated)
- 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 trial testing the outcome of an Internet-based treatment of pathological gambling with the hypothesis that there will be improvements both immediately and up to 36 months. It is also hypnotized that treatment response can be predicted from background variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: cognitive behavior therapyThe treatment was based on established cognitive behavior therapy methods, as described in self-help books (Hodgins, 2002; Ladouceur \& Lachance, 2006). The text was divided into eight modules and was adapted for Internet use. The first four modules had a motivational interviewing focus and included building motivation for change by letting the participant answer open-ended questions that would evoke talk of change. The participants were encouraged to ask for input from their relatives on different aspects of their gambling. In addition, the first four modules included time line follow-back and mapping of the reasons for gambling. The remaining four modules were based on CBT. Each module included information and exercises and ended with three to eight essay-style questions. Feedback on homework assignments was usually given within 24 hr after participants had sent their answers via e-mail. Once weekly, a telephone call was made by the therapists to each participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathological gambling according to DSM and having gambled at least once the past month
- Being atleast 18 years old
- Living in Sweden
Key exclusion criteria (0 listed)
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 behavior therapyThe treatment was based on established cognitive behavior therapy methods, as described in self-help books (Hodgins, 2002; Ladouceur \& Lachance, 2006). The text was divided into eight modules and was adapted for Internet use. The first four modules had a motivational interviewing focus and included building motivation for change by letting the participant answer open-ended questions that would evoke talk of change. The participants were encouraged to ask for input from their relatives on different aspects of their gambling. In addition, the first four modules included time line follow-back and mapping of the reasons for gambling. The remaining four modules were based on CBT. Each module included information and exercises and ended with three to eight essay-style questions. Feedback on homework assignments was usually given within 24 hr after participants had sent their answers via e-mail. Once weekly, a telephone call was made by the therapists to each participant. | Behavioural | Treatment |
Primary outcome
The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
Time frame: 1 month
2 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: 1 week
Quality of Life Inventory
Time frame: Present moment
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 Jun 2011.
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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.
Per Carlbring, PhD principal investigator
Umeå University
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 behavior therapy in people with Pathological Gambling, run by Umeå University 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 3 inclusion and 0 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 Jun 2011. 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?
The National Opinion Research Center DSM Screen for Gambling Problems (NODS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2011.