Clinical trial NCT03145792: Online Coping Skills Counseling for Problem Gambling and Trauma
Official title: Online Coping Skills Counseling for Problem Gambling and Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling Disorder
Trauma, Psychological
Problem Gambling
Posttraumatic Stress Disorder
Lead sponsor: University of Windsor
Sponsor class: OTHER
Collaborators: name: Manitoba Gambling Research Program
name: Treatment Innovations
name: University of Manitoba
First posted: 2017-05-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial examines the efficacy of two behavioral therapies. Seeking Safety, which addresses co-occurring problem gambling (PG) and posttraumatic stress disorder (PTSD), is being compared to Cognitive-Behavioral Therapy for PG, which addresses only PG. Both models are delivered via telehealth.

Detailed description: Our key study question is whether an integrated focus on PG and PTSD (Seeking Safety; SS) offers a useful new option for clinical care compared to a purely problem gambling approach (Cognitive-Behavioral Therapy for PG; CBT-PG). This question-the impact of integrated versus non-integrated treatment for co-occurring disorders-is one of the key issues in the field currently and has never been studied in relation to PG and PTSD.

Our aims are:

1. To conduct an RCT of SS versus CBT-PG in a sample of 84 people with current PG and PTSD (full or subthreshold).
2. To evaluate outcomes from baseline to end of treatment and 12 month followup on two primary variables (money lost gambling and number of gambling sessions) and several secondary variables.

Our hypotheses are: (a) SS will do no worse than CBT-PG on the primary PG outcomes as both treatments are designed to address addiction; i.e., both will show improvement from baseline to end of treatment and maintenance of gains through the followup. (b) SS will show superior results on trauma symptoms as SS is designed to address those, whereas CBT-PG is not.

Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Recruited from the province of Manitoba, Canada
* Meets criteria for PTSD (full or subthreshold) on the Clinician-Administered PTSD Scale (CAPS)
* Meets gambling disorder criteria per the DSM-5 Diagnostic Interview of Gambling Severity

Exclusion Criteria:

* Current uncontrolled psychotic or bipolar I disorder
* Suicidal or homicidal ideation with intent and/or plan
* Currently engaging in or planning to engage in any manualized, formal, evidence-based PTSD therapy

Primary outcomes:
measure: Money spent gambling
timeFrame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
measure: Number of gambling sessions
timeFrame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Secondary outcomes:
measure: PTSD Checklist (PCL) scores
timeFrame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
measure: Trauma Symptom Checklist 40
timeFrame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
measure: Brief Symptom Inventory-18 scores
timeFrame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
measure: Brief Addiction Monitor scores
timeFrame: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months
Other outcomes:
Locations:
city: Newton Center
country: United States
facility: Treatment Innovations
state: Massachusetts
Study officials:
affiliation: University of Windsor
name: David M Ledgerwood, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Treatment Innovations
name: Lisa Najavits, PhD
role: STUDY_DIRECTOR
References: