Alcohol Use DisorderWTPIIINCT03589274
Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
A study testing I-FS-CBT and G-FS-CBT in people with Alcohol Use Disorder, run by Rutgers, The State University of New Jersey.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- I-FS-CBT and G-FS-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2010to 28 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have psychotic symptoms in the past six months
- gross cognitive impairment
- current physiological dependence on any illicit drug
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- I-FS-CBT, G-FS-CBT
- Keywords
- alcohol use disorder, women, female specific therapy, cognitive behavior therapy, group therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-FS-CBTBehavioural
12 manual-guided sessions of I-FS-CBT
G-FS-CBTBehavioural
12 manual-guided sessions of G-FS-CBT
| Study group | Role | What they receive |
|---|---|---|
| I-FS-CBT | Experimental | 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. Receives: Behavioral: I-FS-CBT |
| G-FS-CBT | Experimental | 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. Receives: Behavioral: G-FS-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Drinking Days (PDD)
Derived from Timeline Followback (TLFB)
Measured: Change from baseline across 15 months post-session 1
Percent Heavy Drinking Days (PHDD)
Derived from TLFB; Defined as 4 or more standard drinks per day
Measured: Change from baseline across 15 months post-session 1
Mean Drinks Per Drinking Day (MDPDD)
Derived from TLFB
Measured: Change from baseline across 15 months post-session 1
Secondary outcomes (9)
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.
Measured: Baseline and through study completion, about 15 months
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.
Measured: Baseline and through study completion, about 15 months
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.
Measured: Baseline and through study completion, about 15 months
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
Measured: Baseline and through study completion, about 15 months
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.
Measured: Baseline and through study completion, about 15 months
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.
Measured: Baseline and through study completion, about 15 months
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
Measured: Baseline and through study completion, about 15 months
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
Measured: Baseline and through study completion, about 15 months
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.
Measured: Baseline and through study completion, about 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jun 2010
- Primary completion28 Apr 2014
- Study completion28 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Epstein, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Elizabeth E Epstein, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589274
- Sponsor's protocol ID
- 03-346R08x
- Acronym
- WTPIII
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
- ClinicalTrials.gov ID
- NCT03589274
- Acronym / sponsor ID
- WTPIII / 03-346R08x
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol use disorder, women, female specific therapy, cognitive behavior therapy, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 28 Apr 2014 (actual)
- Study completion
- 28 Apr 2014 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-FS-CBT | Experimental | Behavioral: I-FS-CBTIn 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. |
| G-FS-CBT | Experimental | Behavioral: G-FS-CBTThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- have psychotic symptoms in the past six months
- gross cognitive impairment
- current physiological dependence on any illicit drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-FS-CBT12 manual-guided sessions of I-FS-CBT | Behavioural | I-FS-CBT |
| G-FS-CBT12 manual-guided sessions of G-FS-CBT | Behavioural | G-FS-CBT |
Primary outcome
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
9 secondary outcomes
Beck Depression Inventory II
Time frame: Baseline and through study completion, about 15 months
Anxiety
Time frame: Baseline and through study completion, about 15 months
Sociotropy-Autonomy Scale
Time frame: Baseline and through study completion, about 15 months
Coping Strategies Scale
Time frame: Baseline and through study completion, about 15 months
Situational Confidence Scale 8
Time frame: Baseline and through study completion, about 15 months
Important People Inventory
Time frame: Baseline and through study completion, about 15 months
Self care
Time frame: Baseline and through study completion, about 15 months
Inventory of Personal Problems
Time frame: Baseline and through study completion, about 15 months
Group Environment Scale Form R
Time frame: Baseline and through study completion, about 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth E Epstein, PhD principal investigator
Rutgers, The State University of New Jersey
Questions about this trial
What is this clinical trial studying?
A study testing I-FS-CBT and G-FS-CBT in people with Alcohol Use Disorder, run by Rutgers, The State University of New Jersey.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Drinking Days (PDD) (time frame: Change from baseline across 15 months post-session 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.