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Completed

NCT Number: NCT03589274

Testing CBT Models and Change Mechanisms for Alcohol Dependent Women

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-FS-CBT

Behavioral

12 manual-guided sessions of I-FS-CBT

G-FS-CBT

Behavioral

12 manual-guided sessions of G-FS-CBT

Primary outcomes

  1. Percent Drinking Days (PDD)

    Time frame: Change from baseline across 15 months post-session 1

    Derived from Timeline Followback (TLFB)

  2. 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

  3. Mean Drinks Per Drinking Day (MDPDD)

    Time frame: Change from baseline across 15 months post-session 1

    Derived from TLFB

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  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

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

Other outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Acronym: WTPIII

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2018
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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