<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/NCT02250586</url>
  </required_header>
  <id_info>
    <org_study_id>CBT-CSO-Gambling</org_study_id>
    <nct_id>NCT02250586</nct_id>
  </id_info>
  <brief_title>Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers</brief_title>
  <official_title>Internet Based Cognitive-behavioral Therapy for Concerned Significant Others of Problem Gamblers: a Randomized Wait-list Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stockholm University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stockholm University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem&#xD;
      gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have&#xD;
      devastating effects on the economy, health and relationship, both for the problem gambler and&#xD;
      their concerned significant other (CSO). No empirically supported program exists for the CSOs&#xD;
      of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program&#xD;
      aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles&#xD;
      from cognitive behavioral therapy and motivational interviewing. In order to benefit as many&#xD;
      CSOs as possible, the program will be delivered via the Internet with therapist support via&#xD;
      email and telephone.&#xD;
&#xD;
      METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A&#xD;
      cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem&#xD;
      gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules&#xD;
      over 10 weeks in a secure online environment, and receive support via text messages and over&#xD;
      telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline&#xD;
      3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to&#xD;
      seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship&#xD;
      satisfaction and quality of life.&#xD;
&#xD;
      HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction&#xD;
      in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's&#xD;
      anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and&#xD;
      money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's&#xD;
      relationship satisfaction with the problem gambler.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">August 20, 2018</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inventory of Consequences Scale for the Gambler and CSO</measure>
    <time_frame>Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>9-item Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Generalised Anxiety Disorder 7-item (GAD-7)</measure>
    <time_frame>Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Assessment Scale (generic version)</measure>
    <time_frame>Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO Quality of Life Questionnaire-Bref</measure>
    <time_frame>Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timeline followback method</measure>
    <time_frame>Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.</time_frame>
    <description>CSOs will be asked to report the amount of money spent on gambling by the identified problem gambler.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment engagement</measure>
    <time_frame>Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.</time_frame>
    <description>CSO will be asked to report if and when the identified problem gambler enter treatment. &quot;Entering treatment&quot; is defined as attending at least 1 session or calling the National Gambling Helpline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Gambling</condition>
  <arm_group>
    <arm_group_label>CBT-CSO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The CBT-CSO program will be based on concepts from cognitive-behavioral therapy and motivational interviewing, and is specifically developed for use with CSOs of treatment refusing problem gamblers. The program resembles the community reinforcement and family training approach that has been successfully used with CSOs of substance abusers.&#xD;
The program will be given as guided self-help with guidance given via email and telephone. There are 8 modules, which all contain homework exercises and about 5-10 pages of text.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants allocated to the control condition will be put on a waiting list and offered the CBT-CSO program after 10 weeks. The CSOs will receive information about available treatment options-in their area and web-based-for the problem gambler.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-CSO</intervention_name>
    <description>Internet-delivered cognitive-behavioral therapy for CSO's of treatment refusing problem gamblers</description>
    <arm_group_label>CBT-CSO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The CSO and the gambler are at least 18 years old,&#xD;
&#xD;
          -  The CSO is a parent, child, sibling, friend or partner of the gambler.&#xD;
&#xD;
          -  The CSO must have had a relationship with the gambler for at least 3 months.&#xD;
&#xD;
          -  Neither the CSO nor the gambler has had any treatment in the past 3 months (that is&#xD;
             related to gambling).&#xD;
&#xD;
          -  The gambler is currently refusing help.&#xD;
&#xD;
          -  The CSO is able to read and answer questions in Swedish, and is willing to talk to a&#xD;
             counselor each week.&#xD;
&#xD;
          -  The gambler is a problem gambler according to Problem Gambling Severity Index, as&#xD;
             rated by the CSO.&#xD;
&#xD;
          -  The CSO must agree to have their telephone calls recorded.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of psychotic- or bipolar disorder in the CSO or gambler.&#xD;
&#xD;
          -  CSO meets PGSI criteria for ongoing problem gambling.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stockholm University</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://spel.iterapi.se</url>
    <description>Public website to convey study information and recruitment</description>
  </link>
  <reference>
    <citation>Magnusson K, Nilsson A, Hellner Gumpert C, Andersson G, Carlbring P. Internet-delivered cognitive-behavioural therapy for concerned significant others of people with problem gambling: study protocol for a randomised wait-list controlled trial. BMJ Open. 2015 Dec 9;5(12):e008724. doi: 10.1136/bmjopen-2015-008724.</citation>
    <PMID>26656017</PMID>
  </reference>
  <results_reference>
    <citation>Magnusson K, Nilsson A, Andersson G, Hellner C, Carlbring P. Internet-delivered cognitive-behavioral therapy for significant others of treatment-refusing problem gamblers: A randomized wait-list controlled trial. J Consult Clin Psychol. 2019 Sep;87(9):802-814. doi: 10.1037/ccp0000425.</citation>
    <PMID>31403816</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stockholm University</investigator_affiliation>
    <investigator_full_name>Per Carlbring</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>concerned significant other</keyword>
  <keyword>internet-delivered cognitive-behavioral therapy,</keyword>
  <keyword>treatment-refusing problem gambler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gambling</mesh_term>
  </condition_browse>
  <study_docs>
    <study_doc>
      <doc_id>awtg7</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://osf.io</doc_url>
      <doc_comment>The trial's outcome data and scripts are available for download: https://osf.io/awtg7/</doc_comment>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02250586
org study id: CBT-CSO-Gambling
nct id: NCT02250586
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem
      gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have
      devastating effects on the economy, health and relationship, both for the problem gambler and
      their concerned significant other (CSO). No empirically supported program exists for the CSOs
      of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program
      aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles
      from cognitive behavioral therapy and motivational interviewing. In order to benefit as many
      CSOs as possible, the program will be delivered via the Internet with therapist support via
      email and telephone.

      METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A
      cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem
      gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules
      over 10 weeks in a secure online environment, and receive support via text messages and over
      telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline
      3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to
      seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship
      satisfaction and quality of life.

      HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction
      in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's
      anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and
      money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's
      relationship satisfaction with the problem gambler.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Inventory of Consequences Scale for the Gambler and CSO
time frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: 9-item Patient Health Questionnaire (PHQ-9)
time frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: The Generalised Anxiety Disorder 7-item (GAD-7)
time frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: Relationship Assessment Scale (generic version)
time frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: WHO Quality of Life Questionnaire-Bref
time frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: Timeline followback method
time frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
description: CSOs will be asked to report the amount of money spent on gambling by the identified problem gambler.
measure: Treatment engagement
time frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
description: CSO will be asked to report if and when the identified problem gambler enter treatment. "Entering treatment" is defined as attending at least 1 session or calling the National Gambling Helpline
arm group label: CBT-CSO
arm group type: Experimental
description: The CBT-CSO program will be based on concepts from cognitive-behavioral therapy and motivational interviewing, and is specifically developed for use with CSOs of treatment refusing problem gamblers. The program resembles the community reinforcement and family training approach that has been successfully used with CSOs of substance abusers.
The program will be given as guided self-help with guidance given via email and telephone. There are 8 modules, which all contain homework exercises and about 5-10 pages of text.
arm group label: Wait-list
arm group type: No Intervention
description: The participants allocated to the control condition will be put on a waiting list and offered the CBT-CSO program after 10 weeks. The CSOs will receive information about available treatment options-in their area and web-based-for the problem gambler.
intervention type: Behavioral
intervention name: CBT-CSO
description: Internet-delivered cognitive-behavioral therapy for CSO's of treatment refusing problem gamblers
arm group label: CBT-CSO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
url: https://spel.iterapi.se
description: Public website to convey study information and recruitment
citation: Magnusson K, Nilsson A, Hellner Gumpert C, Andersson G, Carlbring P. Internet-delivered cognitive-behavioural therapy for concerned significant others of people with problem gambling: study protocol for a randomised wait-list controlled trial. BMJ Open. 2015 Dec 9;5(12):e008724. doi: 10.1136/bmjopen-2015-008724.
PMID: 26656017
citation: Magnusson K, Nilsson A, Andersson G, Hellner C, Carlbring P. Internet-delivered cognitive-behavioral therapy for significant others of treatment-refusing problem gamblers: A randomized wait-list controlled trial. J Consult Clin Psychol. 2019 Sep;87(9):802-814. doi: 10.1037/ccp0000425.
PMID: 31403816
responsible party type: Principal Investigator
investigator affiliation: Stockholm University
investigator full name: Per Carlbring
investigator title: Professor
mesh term: Gambling
study doc: 