The Effect of a Brief Intervention for Problem Gamblers

NCT04609007 | Completed

• 1 other identifier: 2017/1063-31
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT). Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.

Conditions

Gambling Problem

Outcome Measures

Primary Outcomes (4)

• Retention at the end of the study

  Retention, defined as proportion of participants who fill out the last follow-up survey

  6-weeks after the intervention

• Time for execution of the study

  Time for execution of the study as measured by the time from the first included participant to the last included,

  from the date of the first included participant to the last included, assessed up to 52 weeks

• Participant rated satisfaction with the treatment protocol

  Participant rated satisfaction with the treatment protocol will be measured using three items at the end of each online treatment module. The items are measured on a VAS scale ranging from 1-5 (1= not at all, 5 = very). Item 1) "How helpful do you think the content of this module has been?" Item 2) "How well does the content of the module fit the problems you experience and want help with?" Item 3) "What grade from 1 to 5 would you give this module?

  measured in conjunction with each online treatment module for up to six weeks (at four occasions)

• Participant rated satisfaction with the treatment at large

  Participant rated satisfaction with the treatment at large will be measured immediately after the intervention using 12 items on a VAS scale ranging from 1 (not at all) to 10 (very). Item 8 answers "yes" or "no" and item 9 is a free-text entry only available if item 8 answers "yes". Items 1- 4 and items 10-12 captures satisfaction with the program and items 5 - 9 captures satisfaction with the therapist.

  immediately after the intervention.

Secondary Outcomes (11)

• Timeline follow-back, days gambling and net losses due to gambling

  At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up

• Problem Gambling Severity Index (PGSI)

  At baseline and at the 6-weeks follow-up

• National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)

  At baseline, immediately after the intervention and at the 6-weeks follow-up

• Alcohol Use Disorders Identification Consumption (AUDIT-C)

  At baseline, immediately after the intervention and at the 6-weeks follow-up

• Drug Use Disorders Identification Test Consumption (DUDIT-C)

  At baseline, immediately after the intervention and at the 6-weeks follow-up

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

The TAU condition consists of a single session of regular help-line telephone counselling

Behavioral: Regular help-line telephone counselling

Cognitive behavioral therapy

EXPERIMENTAL

The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions.

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Cognitive behavioral therapy (CBT) BEHAVIORAL

A brief 4 sessions online CBT program with therapist support.

Cognitive behavioral therapy

Regular help-line telephone counselling BEHAVIORAL

A single session of telephone counselling with a help-line counsellor

Treatment as usual

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years
• Experiencing gambling problems (PGSI ≥ 3 p)
• Good enough knowledge in Swedish
• Access to a smart phone or computer with internet connection

You may not qualify if:

• Being involved in another treatment study the previous 3 months
• Other concurrent treatment for gambling problems
• Being on a non-stable pharmacological treatment for any psychiatric condition
• Severe depression defined as a PHQ-9 score of 20 points or more

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Stockholm Center for Psychiatry Research

Stockholm, 11364, Sweden

Location

Related Publications (1)

• Wall H, Magnusson K, Hellner C, Andersson G, Jayaram-Lindstrom N, Rosendahl I. The evaluation of a brief ICBT program with therapist support for individuals with gambling problems in the context of a gambling helpline: a randomized pilot trial. Pilot Feasibility Stud. 2023 Feb 17;9(1):26. doi: 10.1186/s40814-023-01257-7.

  PMID: 36805024 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Clara Hellner, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: October 30, 2020
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)