Gambling Disorder TreatmentSOMJEUNCT06026722
Behavioral and Cognitive Therapy for Insomnia in the Treatment of Pathological Gambling
A study testing cognitive behavioral therapy for insomnia in people with Gambling Disorder Treatment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Gambling is a public health risk. The wide panel of games available (poker, sport bets, scratch card games, slot machines, stock speculation …) and the advent of the Internet means that this behaviour is increasingly monitored on an epidemiological level, to the point where its pathological practice is now recognized… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gambling Disorder Treatment
- What is being tested?
- cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 1 Oct 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with criteria of chronic gambling disorder according to DSM-5 defined as score greater than or equal to 5 for th South Oaks Gamling Screen (SOGS) and insomnia according to DSM-5 with score at ISI greater than 10.
- Outpatient or day hospitalization for gambling disorder in one of the psychiatric departments of the study centers for a period of care of at least 6 months.
- write, read and speak French
- Affiliated to a social security scheme (excluding State Medical Aid)
- volonteer, able to give their consent, informed
Who cannot join
- Specially protected adult, under guardianship or curatorship, or under therapeutic injunction
- pregnant woman
- Presence of any psychiatric pathology or clinically significant or unstable psychiatric appearance (decompensated bipolar disorder, decompensated schizophrenia, neurodegenerative disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Behavioral and Cognitive Therapy for Insomnia in the Treatment of Pathological Gambling: Randomised and Control Pilot Study
Gambling is a public health risk. The wide panel of games available (poker, sport bets, scratch card games, slot machines, stock speculation …) and the advent of the Internet means that this behaviour is increasingly monitored on an epidemiological level, to the point where its pathological practice is now recognized in the DSM-5. Indeed, the scientific literature suggests a bidirectional link between use disorders and sleep disorders.
Sleep deprivation is known to lead to impaired judgment (risk-taking), increased sensitivity to reward, attentional difficulties and poor emotional management. The reverse has also been demonstrated: for example, playing at night has an impact on sleep quality, particularly in terms of difficulty falling asleep, ruminations about the game and a delay in the sleep-wake phase. Sleep disorders also affect patients undergoing withdrawal and/or cessation of a substance or behavior. This established link between addictions and circadian rhythms is important, since it is suggested that patients who are more impaired in both respects are more likely to relapse and respond less well to treatment.
In addictology, Behavioral and Cognitive Therapy for Insomnia (CBT-I) has proved effective in alcohol-dependent subjects in four studies. All reported a better quality of life (less depressive cognitions, better lifestyle) after CBT-I, although only one study reported a numerical reduction in consumption.The treatment of substance use disorders (AUD) remains limited : no pharmacological treatment has proved its worth, and the reference treatment remains mainly CBT. Despite the indisputable effectiveness of CBT, between 14% and 50% of patients are reported to have broken off from follow-up and care, and almost 90% of patients end up relapsing.
Read the detailed description
Gambling is a public health risk. The wide panel of games available (poker, sports betting, scratch cards, slot machines, even stock market speculation...) and the advent of the Internet mean that this behavior is increasingly monitored from an epidemiological point of view, to the extent that its pathological practice is now recognized in the DSM-5. The DSM-5 characterizes the disorder as maladaptive (i.e., a loss of control leading to negative consequences for daily life), persistent (i.e., to the point of obsessive thoughts about it, and returning to it to "chase losses") and repeated (i.e., the need to play more and more to feel the initial effects) gambling. The Internet has made it possible to access gambling day and night, in complete anonymity, removing any inhibitions and facilitating dematerialized gambling, which is less palpable but just as damaging for patients. According to the "Observatoire des Jeux en France" in 2019, 6% of the French population could be problem gamblers (4.4% at moderate risk, and 1.6% pathological gamblers). Although prohibited for minors, gambling is becoming increasingly democratized among younger populations, and among 17-year-olds who gambled at least once in the year of 2017, 1.6% could be pathological gamblers. According to the e-Games France 2017 survey, being male (OR=1.57), young (OR=6.64), rather educated (OR=2.83), not retired (active, unemployed or student) (OR=26.8), with low income (OR=2.86) are socio-demographic characteristics linked to a higher risk of problem gambling. Moreover, according to the same survey, Internet gambling is more risky than "traditional" gambling, with 9.4% of online gamblers presenting a problem (compared with 0.9% of traditional gamblers) and 13% being pathological gamblers (compared with 3.9%). The health and social impact of online gambling in France remains poorly described, due to the marginalization of gambling disorders (few specialists, "shameful" addiction) and limited access to care. The impact on individuals and their families can be considerable, with financial consequences at the top of the list, including over-indebtedness and bankruptcy. The difficulties can also be relational and familial (separations, isolation, etc.), professional (redundancy, loss of opportunity, etc.), psychological (depression, anxiety, suicide, etc.) or physical (asthenia, symptoms linked to the consumption of alcohol or other psychoactive products, etc.). Scientific literature also suggests a so-called bidirectional link between use disorders and sleep disorders. Sleep deprivation is known to lead to impaired judgment (risk-taking), heightened sensitivity to reward, attentional difficulties and poor emotional management.
The reverse has also been demonstrated: for example, playing at night has an impact on sleep quality, particularly in terms of difficulty falling asleep, ruminations about the game and a delay in the sleep-wake phase. Sleep disorders also affect patients undergoing withdrawal and/or cessation of a substance or behavior. This established link between addictions and circadian rhythms is important, since it is suggested that patients who are more impaired in both respects are more likely to relapse and respond less well to treatment.
Three studies looked briefly at the perceived subjective sleep quality of pathological gamblers (by asking them whether they slept well, yes or no) and also observed more degraded sleep in gamblers compared to controls. Another study found a positive correlation between pathological gambling severity, difficulty falling asleep and poor sleep hygiene.
A larger U.S.-based study (N=3435) also reported that pathological gamblers were significantly more likely to report one or all of three insomnia criteria (difficulty falling asleep, daytime sleepiness, and early waking). Two more recent studies also point in this direction: an Australian study found an association between the DSM-5 diagnosis of insomnia, sleep of poor quality judged by the patient, and the severity of pathological gambling. According to a Canadian study of online poker players, the most sleep-deprived players were the most exposed to financial losses and a greater number of hands played in equal playing time. Other studies even suggest an indirect link between sleep and pathological gambling during periods of extreme stress. The stress of continual losses is associated with poor sleep quality, and between-games phases (i.e., withdrawal) are subject to intense stress, with negative effects on sleep. Finally, on a more objective level, actimetry data revealed poor sleep quality (shortened nights, "non-restorative" sleep, longer sleep times, multiple awakenings) in addicted patients. Given the addictive potential of most hypnotic pharmacological treatments, treating sleep disorders in an addicted patient is always a delicate matter.
However, no study has investigated the therapeutic effect of non-pharmacological treatment of sleep disorders in pathological gamblers.
Behavioral and Cognitive Therapy for Insomnia (CBT-I) is considered the gold standard for the treatment of sleep disorders. CBT-I has 3 main components: psycho-education on sleep hygiene, cognitive therapy and behavioral therapy on stimulus control, sleep restriction and relaxation.
This non-pharmacological intervention has proved effective in improving sleep, fatigue and quality of life in subjects suffering from chronic insomnia, up to 3 years after CBT-I (insomnia severity score ISI down from 18.6 to 13 after CBT-I, with improvement to 11.9 p<0.001 after 3 years in 90% of patients).
In addictology, this therapy has proved effective in alcohol-dependent subjects in four studies. All reported a better quality of life (less depressive cognitions, better lifestyle) after CBT-I, although only one study reported a numerical reduction in consumption.The treatment of substance use disorders (AUD) remains limited : no pharmacological treatment has proved its worth, and the reference treatment remains mainly CBT. Despite the indisputable effectiveness of CBT, between 14% and 50% of patients are reported to have broken off from follow-up and care, and almost 90% of patients end up relapsing.
- Conditions
- Gambling Disorder Treatment
- Being tested
- cognitive behavioral therapy for insomnia
- Keywords
- Gambling disorder,sleep disorder, insomnia, CBT-I, addiction
- Medical subject headings
- Gambling, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapy for insomniaBehavioural
CBT-I is a 4-session program built around 3 main axes: psychoeducation on sleep hygiene, cognitive therapy and behavioral stimulus control, sleep restriction and relaxation. Each of the 3 axes will be worked on over 3 sessions, the last one being a summary and consolidation session of the first 3. For ethical reasons, it has been decided that patients in the control arm will also follow CBT-I (on a waiting list). The control group will have the same follow-up as the experimental group, but will start the intervention 6 months after the experimental group. This will enable all patients to access CBT-I.
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start a month after inclusion. Receives: Behavioral: cognitive behavioral therapy for insomnia |
| control group (waiting list) | Other | patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start 7 month after inclusion. Receives: Behavioral: cognitive behavioral therapy for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of the severity of gambling disorder betwen day 0 and month 4 of inclusion
difference of G-SAS (gambling symptom assessment scale) score between day 0 and month 4
Measured: day 0, month 4 of inclusion
Secondary outcomes (26)
variation of the severity of gambling disorder betwen day 0 and month 7 of inclusion
difference of G-SAS score between day 0 and month 7
Measured: day 0, month 7 of inclusion
variation of the severity of gambling disorder during patient follow up
difference of G-SAS score between day 0, month and month 7
Measured: day0, month4, month 7 of inclusion
variation of relative amplitude of rhythms betwen day 0 and month 7 of inclusion
Measured: day 0, month 7 of inclusion
variation of relative amplitude of rhythms betwen day 0 and month 4 of inclusion
Measured: day 0, month 4 of inclusion
variation of total sleep time betwen Day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
variation of total sleep time betwen Day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
variation wake after sleep onset (WASO) Day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
variation wake after sleep onset (WASO) betwen Day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
change of sleep fragmentation index betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
change in sleep fragmentation index betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
change in sleep efficiency index betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
change in sleep efficiency index betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
change of Insomnia Severity Index (ISI) score betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
change of Insomnia Severity Index (ISI) score betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
change of Pittsburg Sleep Quality Index (PSQI) score betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
change of Pittsburg Sleep Quality Index (PSQI) score betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
change of Munich Chronotype Type Questionnaire (MCTQ) score betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
change of Munich Chronotype Type Questionnaire (MCTQ) score betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
sleep fragmentation index betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
sleep fragmentation index betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
presume sleep time betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
presume sleep time betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
time spend in bed betwen day 0 and month 4 of inclusion
Measured: day 0 and month 4 of inclusion
time spend in bed betwen day 0 and month 7 of inclusion
Measured: day 0 and month 7 of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling Disorder TreatmentStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026722
- Sponsor's protocol ID
- APHP221164
- Other IDs
- 2023-A00397-38
- Acronym
- SOMJEU
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Behavioral and Cognitive Therapy for Insomnia in the Treatment of Pathological Gambling: Randomised and Control Pilot Study
- ClinicalTrials.gov ID
- NCT06026722
- Acronym / sponsor ID
- SOMJEU / APHP221164
- Conditions
- Gambling Disorder Treatment
- Keywords
- Gambling disorder,sleep disorder, insomnia, CBT-I, addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 7 Sep 2023 (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.
Gambling is a public health risk. The wide panel of games available (poker, sport bets, scratch card games, slot machines, stock speculation …) and the advent of the Internet means that this behaviour is increasingly monitored on an epidemiological level, to the point where its pathological practice is now recognized in the DSM-5. Indeed, the scientific literature suggests a bidirectional link between use disorders and sleep disorders.
Sleep deprivation is known to lead to impaired judgment (risk-taking), increased sensitivity to reward, attentional difficulties and poor emotional management. The reverse has also been demonstrated: for example, playing at night has an impact on sleep quality, particularly in terms of difficulty falling asleep, ruminations about the game and a delay in the sleep-wake phase. Sleep disorders also affect patients undergoing withdrawal and/or cessation of a substance or behavior. This established link between addictions and circadian rhythms is important, since it is suggested that patients who are more impaired in both respects are more likely to relapse and respond less well to treatment.
In addictology, Behavioral and Cognitive Therapy for Insomnia (CBT-I) has proved effective in alcohol-dependent subjects in four studies. All reported a better quality of life (less depressive cognitions, better lifestyle) after CBT-I, although only one study reported a numerical reduction in consumption.The treatment of substance use disorders (AUD) remains limited : no pharmacological treatment has proved its worth, and the reference treatment remains mainly CBT. Despite the indisputable effectiveness of CBT, between 14% and 50% of patients are reported to have broken off from follow-up and care, and almost 90% of patients end up relapsing.
Detailed description
Gambling is a public health risk. The wide panel of games available (poker, sports betting, scratch cards, slot machines, even stock market speculation...) and the advent of the Internet mean that this behavior is increasingly monitored from an epidemiological point of view, to the extent that its pathological practice is now recognized in the DSM-5. The DSM-5 characterizes the disorder as maladaptive (i.e., a loss of control leading to negative consequences for daily life), persistent (i.e., to the point of obsessive thoughts about it, and returning to it to "chase losses") and repeated (i.e., the need to play more and more to feel the initial effects) gambling. The Internet has made it possible to access gambling day and night, in complete anonymity, removing any inhibitions and facilitating dematerialized gambling, which is less palpable but just as damaging for patients. According to the "Observatoire des Jeux en France" in 2019, 6% of the French population could be problem gamblers (4.4% at moderate risk, and 1.6% pathological gamblers). Although prohibited for minors, gambling is becoming increasingly democratized among younger populations, and among 17-year-olds who gambled at least once in the year of 2017, 1.6% could be pathological gamblers. According to the e-Games France 2017 survey, being male (OR=1.57), young (OR=6.64), rather educated (OR=2.83), not retired (active, unemployed or student) (OR=26.8), with low income (OR=2.86) are socio-demographic characteristics linked to a higher risk of problem gambling. Moreover, according to the same survey, Internet gambling is more risky than "traditional" gambling, with 9.4% of online gamblers presenting a problem (compared with 0.9% of traditional gamblers) and 13% being pathological gamblers (compared with 3.9%). The health and social impact of online gambling in France remains poorly described, due to the marginalization of gambling disorders (few specialists, "shameful" addiction) and limited access to care. The impact on individuals and their families can be considerable, with financial consequences at the top of the list, including over-indebtedness and bankruptcy. The difficulties can also be relational and familial (separations, isolation, etc.), professional (redundancy, loss of opportunity, etc.), psychological (depression, anxiety, suicide, etc.) or physical (asthenia, symptoms linked to the consumption of alcohol or other psychoactive products, etc.). Scientific literature also suggests a so-called bidirectional link between use disorders and sleep disorders. Sleep deprivation is known to lead to impaired judgment (risk-taking), heightened sensitivity to reward, attentional difficulties and poor emotional management.
The reverse has also been demonstrated: for example, playing at night has an impact on sleep quality, particularly in terms of difficulty falling asleep, ruminations about the game and a delay in the sleep-wake phase. Sleep disorders also affect patients undergoing withdrawal and/or cessation of a substance or behavior. This established link between addictions and circadian rhythms is important, since it is suggested that patients who are more impaired in both respects are more likely to relapse and respond less well to treatment.
Three studies looked briefly at the perceived subjective sleep quality of pathological gamblers (by asking them whether they slept well, yes or no) and also observed more degraded sleep in gamblers compared to controls. Another study found a positive correlation between pathological gambling severity, difficulty falling asleep and poor sleep hygiene.
A larger U.S.-based study (N=3435) also reported that pathological gamblers were significantly more likely to report one or all of three insomnia criteria (difficulty falling asleep, daytime sleepiness, and early waking). Two more recent studies also point in this direction: an Australian study found an association between the DSM-5 diagnosis of insomnia, sleep of poor quality judged by the patient, and the severity of pathological gambling. According to a Canadian study of online poker players, the most sleep-deprived players were the most exposed to financial losses and a greater number of hands played in equal playing time. Other studies even suggest an indirect link between sleep and pathological gambling during periods of extreme stress. The stress of continual losses is associated with poor sleep quality, and between-games phases (i.e., withdrawal) are subject to intense stress, with negative effects on sleep. Finally, on a more objective level, actimetry data revealed poor sleep quality (shortened nights, "non-restorative" sleep, longer sleep times, multiple awakenings) in addicted patients. Given the addictive potential of most hypnotic pharmacological treatments, treating sleep disorders in an addicted patient is always a delicate matter.
However, no study has investigated the therapeutic effect of non-pharmacological treatment of sleep disorders in pathological gamblers.
Behavioral and Cognitive Therapy for Insomnia (CBT-I) is considered the gold standard for the treatment of sleep disorders. CBT-I has 3 main components: psycho-education on sleep hygiene, cognitive therapy and behavioral therapy on stimulus control, sleep restriction and relaxation.
This non-pharmacological intervention has proved effective in improving sleep, fatigue and quality of life in subjects suffering from chronic insomnia, up to 3 years after CBT-I (insomnia severity score ISI down from 18.6 to 13 after CBT-I, with improvement to 11.9 p<0.001 after 3 years in 90% of patients).
In addictology, this therapy has proved effective in alcohol-dependent subjects in four studies. All reported a better quality of life (less depressive cognitions, better lifestyle) after CBT-I, although only one study reported a numerical reduction in consumption.The treatment of substance use disorders (AUD) remains limited : no pharmacological treatment has proved its worth, and the reference treatment remains mainly CBT. Despite the indisputable effectiveness of CBT, between 14% and 50% of patients are reported to have broken off from follow-up and care, and almost 90% of patients end up relapsing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Behavioral: cognitive behavioral therapy for insomniapatient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start a month after inclusion. |
| control group (waiting list) | Other | Behavioral: cognitive behavioral therapy for insomniapatient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start 7 month after inclusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with criteria of chronic gambling disorder according to DSM-5 defined as score greater than or equal to 5 for th South Oaks Gamling Screen (SOGS) and insomnia according to DSM-5 with score at ISI greater than 10.
- Outpatient or day hospitalization for gambling disorder in one of the psychiatric departments of the study centers for a period of care of at least 6 months.
- write, read and speak French
- Affiliated to a social security scheme (excluding State Medical Aid)
- volonteer, able to give their consent, informed
Key exclusion criteria (3 listed)
- Specially protected adult, under guardianship or curatorship, or under therapeutic injunction
- pregnant woman
- Presence of any psychiatric pathology or clinically significant or unstable psychiatric appearance (decompensated bipolar disorder, decompensated schizophrenia, neurodegenerative disease)
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 for insomniaCBT-I is a 4-session program built around 3 main axes: psychoeducation on sleep hygiene, cognitive therapy and behavioral stimulus control, sleep restriction and relaxation. Each of the 3 axes will be worked on over 3 sessions, the last one being a summary and consolidation session of the first 3. For ethical reasons, it has been decided that patients in the control arm will also follow CBT-I (on a waiting list). The control group will have the same follow-up as the experimental group, but will start the intervention 6 months after the experimental group. This will enable all patients to access CBT-I. | Behavioural | control group (waiting list), interventional group |
Primary outcome
variation of the severity of gambling disorder betwen day 0 and month 4 of inclusion
Time frame: day 0, month 4 of inclusion
difference of G-SAS (gambling symptom assessment scale) score between day 0 and month 4
26 secondary outcomes
variation of the severity of gambling disorder betwen day 0 and month 7 of inclusion
Time frame: day 0, month 7 of inclusion
variation of the severity of gambling disorder during patient follow up
Time frame: day0, month4, month 7 of inclusion
variation of relative amplitude of rhythms betwen day 0 and month 7 of inclusion
Time frame: day 0, month 7 of inclusion
variation of relative amplitude of rhythms betwen day 0 and month 4 of inclusion
Time frame: day 0, month 4 of inclusion
variation of total sleep time betwen Day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
variation of total sleep time betwen Day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
variation wake after sleep onset (WASO) Day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
variation wake after sleep onset (WASO) betwen Day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
change of sleep fragmentation index betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
change in sleep fragmentation index betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
change in sleep efficiency index betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
change in sleep efficiency index betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
change of Insomnia Severity Index (ISI) score betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
change of Insomnia Severity Index (ISI) score betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
change of Pittsburg Sleep Quality Index (PSQI) score betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
change of Pittsburg Sleep Quality Index (PSQI) score betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
change of Munich Chronotype Type Questionnaire (MCTQ) score betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
change of Munich Chronotype Type Questionnaire (MCTQ) score betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
sleep fragmentation index betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
sleep fragmentation index betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
presume sleep time betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
presume sleep time betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
time spend in bed betwen day 0 and month 4 of inclusion
Time frame: day 0 and month 4 of inclusion
time spend in bed betwen day 0 and month 7 of inclusion
Time frame: day 0 and month 7 of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Gambling Disorder Treatment
Not yet recruiting
Low-Intensity Focused Ultrasound for Gambling Disorder
Gambling Disorder, Gambling Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
Recruiting
Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders
Deep Brain Stimulation
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.
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 for insomnia in people with Gambling Disorder Treatment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume DAVIDO (01 40 25 82 63 ext. +33, guillaume.davido@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of the severity of gambling disorder betwen day 0 and month 4 of inclusion (time frame: day 0, month 4 of inclusion). 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 7 Sep 2023.