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

NCT06026722 | Unknown

• 2 other identifiers: APHP2211642023-A00397-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gambling Disorder Treatment

Keywords

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

Outcome Measures

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

  day 0, month 4 of inclusion

Secondary Outcomes (26)

• variation of the severity of gambling disorder betwen day 0 and month 7 of inclusion

  day 0, month 7 of inclusion

• variation of the severity of gambling disorder during patient follow up

  day0, month4, month 7 of inclusion

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

  day 0, month 7 of inclusion

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

  day 0, month 4 of inclusion

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

  day 0 and month 4 of inclusion

Study Arms (2)

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.

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.

Behavioral: cognitive behavioral therapy for insomnia

Interventions

cognitive behavioral therapy for insomnia BEHAVIORAL

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.

control group (waiting list); interventional group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat - Claude-Bernard hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

Gambling; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Behavior, Addictive

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Guillaume DAVIDO

CONTACT

01 40 25 82 63; guillaume.davido@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)