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Testing CBT Models and Change Mechanisms for Alcohol Dependent Women (WTPIII)

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
I-FS-CBT
G-FS-CBT
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol use disorder, women, female specific therapy, cognitive behavior therapy, group therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 or older
  • have a current (past year) Diagnostic and Statistical Manual-IV (DSM-IV) alcohol dependence diagnosis
  • used alcohol in the 60 days prior to telephone screening

Exclusion Criteria:

  • have psychotic symptoms in the past six months
  • gross cognitive impairment
  • current physiological dependence on any illicit drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    I-FS-CBT

    G-FS-CBT

    Arm Description

    In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care.

    The G-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care. The session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence.

    Outcomes

    Primary Outcome Measures

    Percent Drinking Days (PDD)
    Derived from Timeline Followback (TLFB)
    Percent Heavy Drinking Days (PHDD)
    Derived from TLFB; Defined as 4 or more standard drinks per day
    Mean Drinks Per Drinking Day (MDPDD)
    Derived from TLFB

    Secondary Outcome Measures

    Beck Depression Inventory II
    self-report questionnaire assessing depression symptoms over the prior two weeks (scores range 0-63) and higher scores indicate greater depression symptomatology. All item scores are summed to attain a total score.
    Anxiety
    Assessed anxiety symptoms in the last week (scores range 0-63) with higher scores indicating higher anxiety symptomatology. Item scores summed to attain total score.
    Sociotropy-Autonomy Scale
    Measures the extent of an individual's concern with others' opinion of herself (sociotropy) and self-confidence, behavioral and emotional independence (autonomy). Sociotropy sub scale ranges from 0 to 64 with higher scores indicating higher sociotropy. Average Sociotropy Scores are attained by averaging items, with total scores from 0 to 4. Autonomy sub scale Score range from 0 to 44 with higher scores indicating greater autonomy. Average Autonomy Scores are attained by averaging items, with total scores from 0 to 4.
    Coping Strategies Scale
    Assessed use frequency of 30 strategies to cope with alcohol use and non-alcohol related situations, on a scale of 1 (never) to 4 (frequently) for a mean score across all items
    Situational Confidence Scale 8
    Measured self-efficacy to abstain from alcohol use in high-risk situations; each item is rated 0% to 100% for a global confidence score.
    Important People Inventory
    Assessed social network structure, network drinking, and network response to drinking and abstinence. Percentage of network accepting/encouraging abstinence and percentage of network abstainers/in recovery were used.
    Self care
    Assessed 8 domains of self-care: seek medical care, have free time, pleasurable activities, social contact, attend treatment, exercise, do nice things for oneself, buy nice things for oneself
    Inventory of Personal Problems
    Assessed problems in 10 interpersonal domains, rated on a 0 to 4 scale. A total sum score was used for this study; higher scores reflect more interpersonal problems
    Group Environment Scale Form R
    Measured 10 group process subscales (e.g., Cohesiveness, Leader Support, Order/Organization, Expressiveness, Anger/Aggression), each with a mean scale score for 4 items rated on a 0-4 scale.

    Full Information

    First Posted
    June 8, 2018
    Last Updated
    July 4, 2018
    Sponsor
    Rutgers, The State University of New Jersey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03589274
    Brief Title
    Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
    Acronym
    WTPIII
    Official Title
    Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2010 (Actual)
    Primary Completion Date
    April 28, 2014 (Actual)
    Study Completion Date
    April 28, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rutgers, The State University of New Jersey

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study has 4 specific aims: (1) To modify our existing Individual Female Specific Cognitive Behavioral Therapy (I-FS-CBT) for Alcohol Use Disorder (AUD) approach to treat women with alcohol dependence in a group format, Group Female Specific Cognitive Behavioral Therapy (G-FS-CBT); (2) To test the relative efficacy of I-FS-CBT and G-FS-CBT; (3) To test hypothesized mechanisms of change in drinking that are common to both treatments, including (a) coping skills and enhanced self-efficacy for abstinence; (b) enhanced sense of autonomy; (c) alleviation of negative affect, and (d) increased social network support for abstinence, and (4) To assess the relative cost-effectiveness of the individual and group treatment.
    Detailed Description
    Participants completed a telephone screen for initial eligibility and were scheduled for an in-person clinical intake interview. Consented women were scheduled for a baseline research interview (BL) approximately one week later. At the end of the BL, participants were randomized to treatment condition. During the 12 session treatment period, women completed assessments at the beginning and end of each therapy session on secondary outcome and therapy process variables. In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence and (b) self-care. The G-FS-CBT manual included material identical to I-FS-CBT, but the session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence. The first session of G-FS-CBT was 2 hours; remaining sessions were 90 minutes. In-person follow-up interviews were done at 3, 9, and 15 months post-session 1.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder
    Keywords
    alcohol use disorder, women, female specific therapy, cognitive behavior therapy, group therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    155 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I-FS-CBT
    Arm Type
    Experimental
    Arm Description
    In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care.
    Arm Title
    G-FS-CBT
    Arm Type
    Experimental
    Arm Description
    The G-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care. The session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence.
    Intervention Type
    Behavioral
    Intervention Name(s)
    I-FS-CBT
    Intervention Description
    12 manual-guided sessions of I-FS-CBT
    Intervention Type
    Behavioral
    Intervention Name(s)
    G-FS-CBT
    Intervention Description
    12 manual-guided sessions of G-FS-CBT
    Primary Outcome Measure Information:
    Title
    Percent Drinking Days (PDD)
    Description
    Derived from Timeline Followback (TLFB)
    Time Frame
    Change from baseline across 15 months post-session 1
    Title
    Percent Heavy Drinking Days (PHDD)
    Description
    Derived from TLFB; Defined as 4 or more standard drinks per day
    Time Frame
    Change from baseline across 15 months post-session 1
    Title
    Mean Drinks Per Drinking Day (MDPDD)
    Description
    Derived from TLFB
    Time Frame
    Change from baseline across 15 months post-session 1
    Secondary Outcome Measure Information:
    Title
    Beck Depression Inventory II
    Description
    self-report questionnaire assessing depression symptoms over the prior two weeks (scores range 0-63) and higher scores indicate greater depression symptomatology. All item scores are summed to attain a total score.
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Anxiety
    Description
    Assessed anxiety symptoms in the last week (scores range 0-63) with higher scores indicating higher anxiety symptomatology. Item scores summed to attain total score.
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Sociotropy-Autonomy Scale
    Description
    Measures the extent of an individual's concern with others' opinion of herself (sociotropy) and self-confidence, behavioral and emotional independence (autonomy). Sociotropy sub scale ranges from 0 to 64 with higher scores indicating higher sociotropy. Average Sociotropy Scores are attained by averaging items, with total scores from 0 to 4. Autonomy sub scale Score range from 0 to 44 with higher scores indicating greater autonomy. Average Autonomy Scores are attained by averaging items, with total scores from 0 to 4.
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Coping Strategies Scale
    Description
    Assessed use frequency of 30 strategies to cope with alcohol use and non-alcohol related situations, on a scale of 1 (never) to 4 (frequently) for a mean score across all items
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Situational Confidence Scale 8
    Description
    Measured self-efficacy to abstain from alcohol use in high-risk situations; each item is rated 0% to 100% for a global confidence score.
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Important People Inventory
    Description
    Assessed social network structure, network drinking, and network response to drinking and abstinence. Percentage of network accepting/encouraging abstinence and percentage of network abstainers/in recovery were used.
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Self care
    Description
    Assessed 8 domains of self-care: seek medical care, have free time, pleasurable activities, social contact, attend treatment, exercise, do nice things for oneself, buy nice things for oneself
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Inventory of Personal Problems
    Description
    Assessed problems in 10 interpersonal domains, rated on a 0 to 4 scale. A total sum score was used for this study; higher scores reflect more interpersonal problems
    Time Frame
    Baseline and through study completion, about 15 months
    Title
    Group Environment Scale Form R
    Description
    Measured 10 group process subscales (e.g., Cohesiveness, Leader Support, Order/Organization, Expressiveness, Anger/Aggression), each with a mean scale score for 4 items rated on a 0-4 scale.
    Time Frame
    Baseline and through study completion, about 15 months
    Other Pre-specified Outcome Measures:
    Title
    End of Treatment Questionnaire
    Description
    Measured client ratings of helpfulness of therapy elements on a 7 point scale of -3 (greatly harmful), -2, -1, 0 (neutral), +1, +2, +3 (greatly helpful).
    Time Frame
    3 months post session 1
    Title
    Working Alliance Inventory - Short Form
    Description
    12-item self-report measure of the therapeutic alliance (7-point scale with a total possible score of 84)
    Time Frame
    Weekly during Treatment, about 15 weeks
    Title
    Therapy Integrity Rating Scale
    Description
    39 five-point Likert scale items to assess domains common to both treatment conditions (e.g., general interventions, female-specific interventions, common factors) and unique to a single treatment condition (e.g., group therapy interventions)
    Time Frame
    Weekly during treatment, about 15 weeks
    Title
    Therapist Checklist
    Description
    Coding treatment components delivered in each session from 3 to 0 as thoroughly, moderately, minimally, or not covered
    Time Frame
    Weekly during Treatment, about 15 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female participants only
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18 or older have a current (past year) Diagnostic and Statistical Manual-IV (DSM-IV) alcohol dependence diagnosis used alcohol in the 60 days prior to telephone screening Exclusion Criteria: have psychotic symptoms in the past six months gross cognitive impairment current physiological dependence on any illicit drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth E Epstein, PhD
    Organizational Affiliation
    Rutgers, The State University of New Jersey
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Testing CBT Models and Change Mechanisms for Alcohol Dependent Women

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