ClinicalTrials.gg
Not yet recruitingNCT06026722SOMJEUUpdated Sep 7, 2023

Behavioral and Cognitive Therapy for Insomnia in the Treatment of Pathological Gambling

An interventional study of cognitive behavioral therapy for insomnia in Gambling Disorder Treatment, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gambling Disorder Treatment

Keywords

  • Gambling disorder,sleep disorder, insomnia, CBT-I, addiction
03

In context

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 128 interventional studies indexed under Gambling.

Browse Gambling studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with criteria of chronic gambling disorder according to 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

Exclusion criteria

Exclusion Criteria:

  • Specially protected adult, under guardianship or curatorship, or under therapeutic injunction
  • pregnant woman
  • Presence of any psychiatric pathology or or unstable psychiatric appearance (decompensated bipolar disorder, decompensated schizophrenia, neurodegenerative disease)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    interventional group

    patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start a month after inclusion.

    Behavioral: cognitive behavioral therapy for insomnia

  • Other
    control group (waiting list)

    patient will follow cognitive behavioral therapy for insomnia 1 per week during 1 month. this therapy will start 7 month after inclusion.

    Behavioral: cognitive behavioral therapy for insomnia

Interventions

  • Behavioralcognitive behavioral therapy for insomnia

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: day 0, month 4 of inclusion

Secondary outcomes

  1. 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

    Time frame: day 0, month 7 of inclusion

  2. variation of the severity of gambling disorder during patient follow up

    difference of G-SAS score between day 0, month and month 7

    Time frame: day0, month4, month 7 of inclusion

  3. variation of relative amplitude of rhythms betwen day 0 and month 7 of inclusion

    Time frame: day 0, month 7 of inclusion

  4. variation of relative amplitude of rhythms betwen day 0 and month 4 of inclusion

    Time frame: day 0, month 4 of inclusion

  5. variation of total sleep time betwen Day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  6. variation of total sleep time betwen Day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  7. variation wake after sleep onset (WASO) Day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  8. variation wake after sleep onset (WASO) betwen Day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  9. change of sleep fragmentation index betwen day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  10. change in sleep fragmentation index betwen day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  11. change in sleep efficiency index betwen day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  12. change in sleep efficiency index betwen day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  13. change of Insomnia Severity Index (ISI) score betwen day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  14. change of Insomnia Severity Index (ISI) score betwen day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  15. 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

  16. 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

  17. 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

  18. 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

  19. change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  20. change of Epworth Sleepiness Scale (ESS) score betwen day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  21. sleep fragmentation index betwen day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  22. sleep fragmentation index betwen day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  23. presume sleep time betwen day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  24. presume sleep time betwen day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

  25. time spend in bed betwen day 0 and month 4 of inclusion

    Time frame: day 0 and month 4 of inclusion

  26. time spend in bed betwen day 0 and month 7 of inclusion

    Time frame: day 0 and month 7 of inclusion

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06026722
Responsible party
Sponsor
First posted
Sep 7, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Feb 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Sep 7, 2023

Study contacts

Guillaume DAVIDO
Contact
guillaume.davido@aphp.fr
01 40 25 82 63 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion