NCT01868867

Brief Summary

The goal of this study is to examine the use of new technologies in disseminating and improving CBT treatment for adolescent depression. An on-line therapist training tutorial will be followed by 12 weeks of CBT treatment according to the training protocol. CBT treatment will be augmented with the use of automated text messages for homework reminders and reinforcement of learning. In session patient education and review of CBT concepts will be augmented through teaching materials delivered via iPad. 16 therapists will be recruited, each treating 4 depressed adolescents. Half the therapists will be randomly assigned to TAU, followed by the training intervention. Automated patient outcomes measures will be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2013

Typical duration for not_applicable depression

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

May 29, 2013

Last Update Submit

February 1, 2016

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • QUIDS Quick Inventory for Adolescent Depression

    The QUIDS assesses clinical domains of adolescent depression

    change from baseline to 12 weeks

Secondary Outcomes (1)

  • Clinical Global Impressions (CGI)

    end of 12 weeks

Other Outcomes (3)

  • PHQ-9

    change from baseline to 12 weeks

  • Hamilton Depression Rating Scale (HAMD)

    change from baseline to 12 weeks

  • System Usability Scale (SUS)

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Receives on line training and text messaging for treatment

Behavioral: Intervention

Treatment as Usual

NO INTERVENTION

Treatment as usual (TAU) for similar duration as intervention group. Intervention provided following TAU period.

Interventions

InterventionBEHAVIORAL

On line tutorial followed by text messaging during treatment and iPad for patient education

Intervention

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents with a DSM-5 mood disorder and a minimum score of 11 on the QUIDS

You may not qualify if:

  • Bipolar disorder,
  • Severe Conduct Disorder,
  • Moderate to severe Alcohol or Substance Use Disorder,
  • Autism Spectrum Disorder,
  • Any Psychotic Disorder,
  • Severe suicidal/homicidal ideation or behavior requiring inpatient treatment.
  • Non-English speakers and adolescents without daily access to a cell phone will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Telepsychology / Psychological Consultation

Madison, Wisconsin, 53717, United States

Location

Related Publications (3)

  • Kobak KA, Craske MG, Rose RD, Wolitsky-Taylor K. Web-based therapist training on cognitive behavior therapy for anxiety disorders: a pilot study. Psychotherapy (Chic). 2013 Jun;50(2):235-47. doi: 10.1037/a0030568. Epub 2013 Feb 11.

    PMID: 23398031BACKGROUND

  • Mundt JC, Barth B, Reyes T. Clinical Assessment of Adolescent Depression Using Dynamic, Interactive, Computer-Automated SMS Texting. Presented at the 2010 mHealth Summit, Washington, D.C. November, 2010.

    BACKGROUND

  • Mundt JC, Emslie GJ, Reyes T, Mayes TL, Joyner K, King J. Assessing feasibility, reliability, and validity of computer-automated interactive SMS text messages to self-report depression symptoms in children and adolescents using the Quick Inventory of Depressive Symptomatology-Adolescent. New Clinical Drug Evaluation Unit, 51st Annual Meeting. Boca Raton, FL. June 2011.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

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

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 5, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(1)