xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026722</url>
    </required_header>
    <id_info>
      <org_study_id>APHP221164</org_study_id>
      <secondary_id>2023-A00397-38</secondary_id>
      <nct_id>NCT06026722</nct_id>
    </id_info>
    <brief_title>Behavioral and Cognitive Therapy for Insomnia in the Treatment of Pathological Gambling</brief_title>
    <acronym>SOMJEU</acronym>
    <official_title>&quot;Behavioral and Cognitive Therapy for Insomnia in the Treatment of Pathological Gambling: Randomised and Control Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Gambling is a public health risk. The wide panel of games available (poker, sport bets,&#xD;
        scratch card games, slot machines, stock speculation …) and the advent of the Internet means&#xD;
        that this behaviour is increasingly monitored on an epidemiological level, to the point where&#xD;
        its pathological practice is now recognized in the DSM-5. Indeed, the scientific literature&#xD;
        suggests a bidirectional link between use disorders and sleep disorders.&#xD;
  &#xD;
        Sleep deprivation is known to lead to impaired judgment (risk-taking), increased sensitivity&#xD;
        to reward, attentional difficulties and poor emotional management. The reverse has also been&#xD;
        demonstrated: for example, playing at night has an impact on sleep quality, particularly in&#xD;
        terms of difficulty falling asleep, ruminations about the game and a delay in the sleep-wake&#xD;
        phase. Sleep disorders also affect patients undergoing withdrawal and/or cessation of a&#xD;
        substance or behavior. This established link between addictions and circadian rhythms is&#xD;
        important, since it is suggested that patients who are more impaired in both respects are&#xD;
        more likely to relapse and respond less well to treatment.&#xD;
  &#xD;
        In addictology, Behavioral and Cognitive Therapy for Insomnia (CBT-I) has proved effective in&#xD;
        alcohol-dependent subjects in four studies. All reported a better quality of life (less&#xD;
        depressive cognitions, better lifestyle) after CBT-I, although only one study reported a&#xD;
        numerical reduction in consumption.The treatment of substance use disorders (AUD) remains&#xD;
        limited : no pharmacological treatment has proved its worth, and the reference treatment&#xD;
        remains mainly CBT. Despite the indisputable effectiveness of CBT, between 14% and 50% of&#xD;
        patients are reported to have broken off from follow-up and care, and almost 90% of patients&#xD;
        end up relapsing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gambling is a public health risk. The wide panel of games available (poker, sports betting,&#xD;
        scratch cards, slot machines, even stock market speculation...) and the advent of the&#xD;
        Internet mean that this behavior is increasingly monitored from an epidemiological point of&#xD;
        view, to the extent that its pathological practice is now recognized in the DSM-5. The DSM-5&#xD;
        characterizes the disorder as maladaptive (i.e., a loss of control leading to negative&#xD;
        consequences for daily life), persistent (i.e., to the point of obsessive thoughts about it,&#xD;
        and returning to it to &quot;chase losses&quot;) and repeated (i.e., the need to play more and more to&#xD;
        feel the initial effects) gambling. The Internet has made it possible to access gambling day&#xD;
        and night, in complete anonymity, removing any inhibitions and facilitating dematerialized&#xD;
        gambling, which is less palpable but just as damaging for patients. According to the&#xD;
        &quot;Observatoire des Jeux en France&quot; in 2019, 6% of the French population could be problem&#xD;
        gamblers (4.4% at moderate risk, and 1.6% pathological gamblers). Although prohibited for&#xD;
        minors, gambling is becoming increasingly democratized among younger populations, and among&#xD;
        17-year-olds who gambled at least once in the year of 2017, 1.6% could be pathological&#xD;
        gamblers. According to the e-Games France 2017 survey, being male (OR=1.57), young (OR=6.64),&#xD;
        rather educated (OR=2.83), not retired (active, unemployed or student) (OR=26.8), with low&#xD;
        income (OR=2.86) are socio-demographic characteristics linked to a higher risk of problem&#xD;
        gambling. Moreover, according to the same survey, Internet gambling is more risky than&#xD;
        &quot;traditional&quot; gambling, with 9.4% of online gamblers presenting a problem (compared with 0.9%&#xD;
        of traditional gamblers) and 13% being pathological gamblers (compared with 3.9%). The health&#xD;
        and social impact of online gambling in France remains poorly described, due to the&#xD;
        marginalization of gambling disorders (few specialists, &quot;shameful&quot; addiction) and limited&#xD;
        access to care. The impact on individuals and their families can be considerable, with&#xD;
        financial consequences at the top of the list, including over-indebtedness and bankruptcy.&#xD;
        The difficulties can also be relational and familial (separations, isolation, etc.),&#xD;
        professional (redundancy, loss of opportunity, etc.), psychological (depression, anxiety,&#xD;
        suicide, etc.) or physical (asthenia, symptoms linked to the consumption of alcohol or other&#xD;
        psychoactive products, etc.). Scientific literature also suggests a so-called bidirectional&#xD;
        link between use disorders and sleep disorders. Sleep deprivation is known to lead to&#xD;
        impaired judgment (risk-taking), heightened sensitivity to reward, attentional difficulties&#xD;
        and poor emotional management.&#xD;
  &#xD;
        The reverse has also been demonstrated: for example, playing at night has an impact on sleep&#xD;
        quality, particularly in terms of difficulty falling asleep, ruminations about the game and a&#xD;
        delay in the sleep-wake phase. Sleep disorders also affect patients undergoing withdrawal&#xD;
        and/or cessation of a substance or behavior. This established link between addictions and&#xD;
        circadian rhythms is important, since it is suggested that patients who are more impaired in&#xD;
        both respects are more likely to relapse and respond less well to treatment.&#xD;
  &#xD;
        Three studies looked briefly at the perceived subjective sleep quality of pathological&#xD;
        gamblers (by asking them whether they slept well, yes or no) and also observed more degraded&#xD;
        sleep in gamblers compared to controls. Another study found a positive correlation between&#xD;
        pathological gambling severity, difficulty falling asleep and poor sleep hygiene.&#xD;
  &#xD;
        A larger U.S.-based study (N=3435) also reported that pathological gamblers were&#xD;
        significantly more likely to report one or all of three insomnia criteria (difficulty falling&#xD;
        asleep, daytime sleepiness, and early waking). Two more recent studies also point in this&#xD;
        direction: an Australian study found an association between the DSM-5 diagnosis of insomnia,&#xD;
        sleep of poor quality judged by the patient, and the severity of pathological gambling.&#xD;
        According to a Canadian study of online poker players, the most sleep-deprived players were&#xD;
        the most exposed to financial losses and a greater number of hands played in equal playing&#xD;
        time. Other studies even suggest an indirect link between sleep and pathological gambling&#xD;
        during periods of extreme stress. The stress of continual losses is associated with poor&#xD;
        sleep quality, and between-games phases (i.e., withdrawal) are subject to intense stress,&#xD;
        with negative effects on sleep. Finally, on a more objective level, actimetry data revealed&#xD;
        poor sleep quality (shortened nights, &quot;non-restorative&quot; sleep, longer sleep times, multiple&#xD;
        awakenings) in addicted patients. Given the addictive potential of most hypnotic&#xD;
        pharmacological treatments, treating sleep disorders in an addicted patient is always a&#xD;
        delicate matter.&#xD;
  &#xD;
        However, no study has investigated the therapeutic effect of non-pharmacological treatment of&#xD;
        sleep disorders in pathological gamblers.&#xD;
  &#xD;
        Behavioral and Cognitive Therapy for Insomnia (CBT-I) is considered the gold standard for the&#xD;
        treatment of sleep disorders. CBT-I has 3 main components: psycho-education on sleep hygiene,&#xD;
        cognitive therapy and behavioral therapy on stimulus control, sleep restriction and&#xD;
        relaxation.&#xD;
  &#xD;
        This non-pharmacological intervention has proved effective in improving sleep, fatigue and&#xD;
        quality of life in subjects suffering from chronic insomnia, up to 3 years after CBT-I&#xD;
        (insomnia severity score ISI down from 18.6 to 13 after CBT-I, with improvement to 11.9&#xD;
        p&lt;0.001 after 3 years in 90% of patients).&#xD;
  &#xD;
        In addictology, this therapy has proved effective in alcohol-dependent subjects in four&#xD;
        studies. All reported a better quality of life (less depressive cognitions, better lifestyle)&#xD;
        after CBT-I, although only one study reported a numerical reduction in consumption.The&#xD;
        treatment of substance use disorders (AUD) remains limited : no pharmacological treatment has&#xD;
        proved its worth, and the reference treatment remains mainly CBT. Despite the indisputable&#xD;
        effectiveness of CBT, between 14% and 50% of patients are reported to have broken off from&#xD;
        follow-up and care, and almost 90% of patients end up relapsing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>variation of the severity of gambling disorder betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0, month 4 of inclusion</time_frame>
      <description>difference of G-SAS (gambling symptom assessment scale) score between day 0 and month 4</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>variation of the severity of gambling disorder betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0, month 7 of inclusion</time_frame>
      <description>difference of G-SAS score between day 0 and month 7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>variation of the severity of gambling disorder during patient follow up</measure>
      <time_frame>day0, month4, month 7 of inclusion</time_frame>
      <description>difference of G-SAS score between day 0, month and month 7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>variation of relative amplitude of rhythms betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0, month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>variation of relative amplitude of rhythms betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0, month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>variation of total sleep time betwen Day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>variation of total sleep time betwen Day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>variation wake after sleep onset (WASO) Day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>variation wake after sleep onset (WASO) betwen Day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of sleep fragmentation index betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in sleep fragmentation index betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in sleep efficiency index betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in sleep efficiency index betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Insomnia Severity Index (ISI) score betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Insomnia Severity Index (ISI) score betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Pittsburg Sleep Quality Index (PSQI) score betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Pittsburg Sleep Quality Index (PSQI) score betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Munich Chronotype Type Questionnaire (MCTQ) score betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Munich Chronotype Type Questionnaire (MCTQ) score betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sleep fragmentation index betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sleep fragmentation index betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>presume sleep time betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>presume sleep time betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time spend in bed betwen day 0 and month 4 of inclusion</measure>
      <time_frame>day 0 and month 4 of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time spend in bed betwen day 0 and month 7 of inclusion</measure>
      <time_frame>day 0 and month 7 of inclusion</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Gambling Disorder Treatment</condition>
    <arm_group>
      <arm_group_label>interventional group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start a month after inclusion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group (waiting list)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start 7 month after inclusion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>cognitive behavioral therapy for insomnia</intervention_name>
      <description>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.</description>
      <arm_group_label>control group (waiting list)</arm_group_label>
      <arm_group_label>interventional group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with criteria of chronic gambling disorder according to DSM-5 defined as score&#xD;
               greater than or equal to 5 for th South Oaks Gamling Screen (SOGS) and insomnia&#xD;
               according to DSM-5 with score at ISI greater than 10.&#xD;
  &#xD;
            -  Outpatient or day hospitalization for gambling disorder in one of the psychiatric&#xD;
               departments of the study centers for a period of care of at least 6 months.&#xD;
  &#xD;
            -  write, read and speak French&#xD;
  &#xD;
            -  Affiliated to a social security scheme (excluding State Medical Aid)&#xD;
  &#xD;
            -  volonteer, able to give their consent, informed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Specially protected adult, under guardianship or curatorship, or under therapeutic&#xD;
               injunction&#xD;
  &#xD;
            -  pregnant woman&#xD;
  &#xD;
            -  Presence of any psychiatric pathology or clinically significant or unstable&#xD;
               psychiatric appearance (decompensated bipolar disorder, decompensated schizophrenia,&#xD;
               neurodegenerative disease)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Guillaume DAVIDO</last_name>
      <phone>01 40 25 82 63</phone>
      <phone_ext>+33</phone_ext>
      <email>guillaume.davido@aphp.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bichat - Claude-Bernard hospital</name>
        <address>
          <city>Paris</city>
          <zip>75018</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gambling disorder,sleep disorder, insomnia, CBT-I, addiction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
      <mesh_term>Gambling</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026722
  org study id: APHP221164
  secondary id: 2023-A00397-38
  nct id: NCT06026722
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: variation of the severity of gambling disorder betwen day 0 and month 4 of inclusion
  time frame: day 0, month 4 of inclusion
  description: difference of G-SAS (gambling symptom assessment scale) score between day 0 and month 4
  measure: variation of the severity of gambling disorder betwen day 0 and month 7 of inclusion
  time frame: day 0, month 7 of inclusion
  description: difference of G-SAS score between day 0 and month 7
  measure: variation of the severity of gambling disorder during patient follow up
  time frame: day0, month4, month 7 of inclusion
  description: difference of G-SAS score between day 0, month and month 7
  measure: variation of relative amplitude of rhythms betwen day 0 and month 7 of inclusion
  time frame: day 0, month 7 of inclusion
  measure: variation of relative amplitude of rhythms betwen day 0 and month 4 of inclusion
  time frame: day 0, month 4 of inclusion
  measure: variation of total sleep time betwen Day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: variation of total sleep time betwen Day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: variation wake after sleep onset (WASO) Day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: variation wake after sleep onset (WASO) betwen Day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: change of sleep fragmentation index betwen day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: change in sleep fragmentation index betwen day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: change in sleep efficiency index betwen day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: change in sleep efficiency index betwen day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: change of Insomnia Severity Index (ISI) score betwen day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: change of Insomnia Severity Index (ISI) score betwen day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: 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
  measure: 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
  measure: 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
  measure: 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
  measure: change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: sleep fragmentation index betwen day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: sleep fragmentation index betwen day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: presume sleep time betwen day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: presume sleep time betwen day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  measure: time spend in bed betwen day 0 and month 4 of inclusion
  time frame: day 0 and month 4 of inclusion
  measure: time spend in bed betwen day 0 and month 7 of inclusion
  time frame: day 0 and month 7 of inclusion
  arm group label: interventional group
  arm group type: Experimental
  description: patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start a month after inclusion.
  arm group label: control group (waiting list)
  arm group type: Other
  description: patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start 7 month after inclusion.
  intervention type: Behavioral
  intervention name: cognitive behavioral therapy for insomnia
  description: 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.
  arm group label: control group (waiting list)
  arm group label: interventional group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Guillaume DAVIDO
  phone: 01 40 25 82 63
  phone ext: +33
  email: guillaume.davido@aphp.fr
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Sleep Initiation and Maintenance Disorders
  mesh term: Gambling
  sharing ipd: No