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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589274
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth Epstein, Ph.D., Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE June 8, 2018
First Posted Date  ICMJE July 17, 2018
Last Update Posted Date July 17, 2018
Actual Study Start Date  ICMJE June 1, 2010
Actual Primary Completion Date April 28, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2018)
  • Percent Drinking Days (PDD) [ Time Frame: Change from baseline across 15 months post-session 1 ]
    Derived from Timeline Followback (TLFB)
  • Percent Heavy Drinking Days (PHDD) [ Time Frame: Change from baseline across 15 months post-session 1 ]
    Derived from TLFB; Defined as 4 or more standard drinks per day
  • Mean Drinks Per Drinking Day (MDPDD) [ Time Frame: Change from baseline across 15 months post-session 1 ]
    Derived from TLFB
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2018)
  • Beck Depression Inventory II [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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 [ Time Frame: Baseline and through study completion, about 15 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 4, 2018)
  • End of Treatment Questionnaire [ Time Frame: 3 months post session 1 ]
    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).
  • Working Alliance Inventory - Short Form [ Time Frame: Weekly during Treatment, about 15 weeks ]
    12-item self-report measure of the therapeutic alliance (7-point scale with a total possible score of 84)
  • Therapy Integrity Rating Scale [ Time Frame: Weekly during treatment, about 15 weeks ]
    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)
  • Therapist Checklist [ Time Frame: Weekly during Treatment, about 15 weeks ]
    Coding treatment components delivered in each session from 3 to 0 as thoroughly, moderately, minimally, or not covered
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
Official Title  ICMJE Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Behavioral: I-FS-CBT
    12 manual-guided sessions of I-FS-CBT
  • Behavioral: G-FS-CBT
    12 manual-guided sessions of G-FS-CBT
Study Arms  ICMJE
  • Experimental: I-FS-CBT
    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.
    Intervention: Behavioral: I-FS-CBT
  • Experimental: G-FS-CBT
    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: Behavioral: G-FS-CBT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2018)
155
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 28, 2014
Actual Primary Completion Date April 28, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female participants only
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03589274
Other Study ID Numbers  ICMJE 03-346R08x
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Epstein, Ph.D., Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth E Epstein, PhD Rutgers, The State University of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP