A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence

Sponsor

New Leaf Treatment Center (Other)

Overall Status

Completed

CT.gov ID

NCT01577797

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase I, randomized, 22-day crossover study seeks to improve treatment outcomes for methamphetamine-dependent subjects by developing a cognitive behavioral therapy (CBT)- based short message service (SMS) text messaging intervention as an adjunct to CBT group therapy.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Behavioral: Text messages	Phase 1

Detailed Description

Psychosocial therapies for methamphetamine (MA) addiction all have limited effectiveness, and patients treated for MA dependence have a high rate of relapse. Additionally, there are no currently approved medications for MA dependence. Thus, a significant need exists for add-on therapy for treatment of MA addiction. CBT-based text messaging could serve as a real-time intervention when craving and risk of MA use are high and patients are not in the clinic. It could further serve to reinforce CBT group therapy. If found efficacious, fully-automated CBT-based text messaging would be a relatively inexpensive adjunctive therapy that could be readily scaled up for use in a large number of patients. Additionally, this type of text messaging intervention also could be tailored to individual users, which may enhance its efficacy. This Phase I randomized crossover study will evaluate the feasibility and preliminary efficacy of CBT-based text messages in conjunction with CBT group therapy delivered over a 22-day period in MA users in the San Francisco Bay Area.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT-based text messages - Week 1 or 3 One week CBT-based text messages followed by a 1-week washout period (Week 2)	Behavioral: Text messages Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine
Placebo Comparator: Placebo text messages - Week 3 or 1	Behavioral: Text messages Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine

Arm

Intervention/Treatment

Experimental: CBT-based text messages - Week 1 or 3

One week CBT-based text messages followed by a 1-week washout period (Week 2)

Behavioral: Text messages

Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine

Placebo Comparator: Placebo text messages - Week 3 or 1

Behavioral: Text messages

Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine

Outcome Measures

Primary Outcome Measures

Feasibility of the intervention in methamphetamine users [22 days]
Subjects will respond to >50% of text messaging inquiries (about the usefulness of the messages, maximum degree of craving, and whether they have used that day).

Secondary Outcome Measures

Acceptability of the intervention in methamphetamine users [22 days]
Based on responses to follow-up visit questionnaires, is 4 times per day the "right amount" of text messages for subjects to receive each day? Is a 13-hour period in which subjects would receive messages appropriate? Was the software system selected for this study acceptable? Were the CBT-based text messages overall perceived as useful? Were the placebo text messages overall perceived as useful?