NCT02024620

Brief Summary

Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for real-time tracking of behavior and have the ability to provide prompt feedback and reminders in a convenient, readily available technology. The immediacy and convenience of apps may be responsible for the observed improvements in adherence on the part of the patients relative to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy. These features are relevant to behavioral activation (BA) protocols, the effects of which are often attenuated by failure to adhere to regular practice and tracking of behavior. The Mood Coach app is a BA protocol developed to provide a convenient means of planning and tracking activity, and monitoring mood responses to scheduled increases in activity. This project evaluates the utility of this app as an adjunct to standard BA treatment. The investigators predict that participants assigned to the BA+app condition will demonstrate greater adherence to the BA treatment compared to the standard BA condition. The investigators also predict that the participants in the BA+app condition will report greater satisfaction with the app compared to the standard BA protocol that utilizes paper and pencil materials.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

December 4, 2013

Last Update Submit

December 14, 2015

Conditions

Keywords

depressiontechnologypsychotherapybehavioral activation

Outcome Measures

Primary Outcomes (1)

  • Change in Behavioral Activation for Depression Scale-Short Form

    Measures symptoms of depression consistent with a behavioral deficits model in a brief format.

    Week 1, Week 4, Week 8

Secondary Outcomes (1)

  • Change in Depression Anxiety Stress Scales-21

    Week 1, Week 4, Week 8

Other Outcomes (4)

  • Homework Compliance Rating Scale

    Week 4, Week 8

  • Treatment Evaluation Inventory-Short Form

    Week 4, Week 8

  • Perceptions of Computerized Therapy Questionnaire-Patient Version

    Week 1, Week 8

  • +1 more other outcomes

Study Arms (2)

Behavioral activation plus mobile app

EXPERIMENTAL

Standard behavioral activation protocol with the addition of the Mood Coach mobile app to replace the paper and pencil forms used in the standard protocol.

Behavioral: Behavioral activation plus mobile app

Standard behavioral activation

ACTIVE COMPARATOR

Standard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion.

Behavioral: Standard behavioral activation

Interventions

Behavioral activation plus mobile app
Standard behavioral activation

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans aged 18 and older
  • Speak and understand English
  • Meet criteria for major depressive disorder
  • Willing to participate in psychotherapy for depression

You may not qualify if:

  • Current psychotic disorder diagnosis
  • Current bipolar disorder
  • Diagnosed with a substance use disorder that is not currently being addressed by a non-study provider
  • Patients receiving a concurrent evidence-based psychotherapy for depression or PTSD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Arkansas Veterans Healthcare System

North Little Rock, Arkansas, 72114, United States

Location

Related Publications (2)

  • Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.

    PMID: 21324944BACKGROUND
  • Newman MG, Szkodny LE, Llera SJ, Przeworski A. A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: is human contact necessary for therapeutic efficacy? Clin Psychol Rev. 2011 Feb;31(1):89-103. doi: 10.1016/j.cpr.2010.09.008. Epub 2010 Oct 14.

    PMID: 21130939BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Robert E Brady, Ph.D.

    Central Arkansas Veterans Healthcare System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 31, 2013

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations