NCT02705898

Brief Summary

Building on the large body of evidence for the effect of exercise in decreasing depressive symptoms and the few preliminary findings of its effect on craving and drinking outcomes, the purpose of this study is to develop a lifestyle physical activity (LPA) intervention that harnesses the technological advantages of the Fitbit tracker (plus its web and mobile platforms) for depressed women with alcohol use disorders (AUDs). The intervention will provide women with an acceptable, flexible and effective alternate coping strategy during early recovery, when relapse risk is highest. The overall objective of this work is to fully develop this LPA+Fitbit intervention, modify it based on initial piloting and feedback to ensure its feasibility and acceptability for depressed women with AUDs in early recovery, propose potential mechanisms of its effect, and to obtain preliminary data on its efficacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

3.9 years

First QC Date

February 29, 2016

Last Update Submit

August 1, 2019

Conditions

Alcohol Dependence

Keywords

alcohol use disordersphysical activitywomen's health

Outcome Measures

Primary Outcomes (1)

  • Percent days abstinent

    6-months

Secondary Outcomes (6)

  • Level of depressive symptoms as measured by the Quick Inventory of Depressive Symptomatology (QIDS)

    6-months

  • Steps/day as measured by the actigraphy

    6-months

  • Positive coping scores on the Brief COPE measure

    6-months

  • Level of motivation for abstinence using the Contemplation Ladder

    6-months

  • Level of self-efficacy on the Alcohol Abstinence Self-Efficacy Scale

    6-months

  • +1 more secondary outcomes

Study Arms (2)

LPA+Fitbit

EXPERIMENTAL

A 12-week LPA+Fitbit intervention for depressed women in intensive alcohol treatment. This will include: 1) a single in-person physical activity (PA) counseling orientation session; 2) 6 brief, phone-based PA counseling sessions focused on increasing PA and strategically using bouts of PA to cope with affect and alcohol cravings; 3) use of the Fitbit fitness tracker for physical activity goal-setting and daily self-monitoring; and 4) weekly supportive messages delivered by email.

Behavioral: LPA+Fitbit

Health Education Contact Control (HEC)

ACTIVE COMPARATOR

The HEC condition will include: 1) an in-person orientation session, 2) 6 telephone-delivered health education sessions, and 3) weekly health-related e-mails. A variety of health and lifestyle topics will be addressed including the following: Session 1 (week 1) - Nutrition-What to Eat and What Not to Eat; Session 2 (week 2) - Sleep Problems and Sleep Hygiene; Session 3 (week 4) - Alcohol Use among Women; Session 4 (week 6) - Relaxation training; Session 5 (week 8) - Time Management and Assertiveness; and Session 6 (week 10) - Being a Smart Patient when Coordinating your Healthcare.

Behavioral: HEC

Interventions

LPA+FitbitBEHAVIORAL
LPA+Fitbit
HECBEHAVIORAL
Health Education Contact Control (HEC)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • currently engaged in alcohol treatment
  • meets criteria for DSM-5 alcohol use disorder
  • score of 1 on ONE of the first 2 items of the Patient Health Questionnaire (PHQ-9)
  • less than 150 minutes of moderate-intensity aerobic exercise per week over the last 6 months
  • has access to a computer connected to the internet or a smartphone compatible with the Fitbit application

You may not qualify if:

  • current DSM-5 diagnosis of moderate/severe substance use disorder, anorexia, or bulimia
  • history of psychotic disorder or current psychotic symptoms
  • current suicidality or homicidality
  • current mania
  • marked organic impairment
  • physical or medical problems that would not allow safe participation in exercise
  • currently pregnant or intending to be pregnant in the next 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

AlcoholismMotor Activity

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 11, 2016

Study Start

September 1, 2015

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

August 5, 2019

Record last verified: 2019-08

Locations

US(1)