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N/A Completed N=312 Randomized Single-blind Treatment

Stepped Telemental Health Care Intervention for Depression

Depression
Source: ClinicalTrials.gov NCT01906476 ↗
Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Depression — 10.51; 11.22; 7.84; 7.71 units on a scale

Summary

This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT) with a therapist to a "Stepped Care" intervention for depression treatment (iCBT with support from a telephone coach with the possibility of being stepped up to receiving T-CBT with a therapist).

Outcome Measures

OutcomeResultp-value
PRIMARY
Depression		 10.51; 11.22; 7.84; 7.71; 7.78; 7.88 —
PRIMARY
Cost-Effectiveness		 391.81; 756.14 —

Eligibility Criteria

Inclusion Criteria

  • Has a DSM-IV diagnosis of non-psychotic major depressive disorder (MDD) as assessed using the Mini International Neuropsychiatric Interview (MINI), plus a score of 12 or greater on the Quick Inventory of Depressive Symptomatology - Clinician Rated (QIDS-C)
  • Has a phone, access to the Internet, and basic internet skills
  • Is at least 18 years of age
  • Is able to speak and read English
  • If currently taking an antidepressant medication, participant must have been on a stable dose for at least two weeks, and have no plans to change the dose

Exclusion Criteria

  • Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use or other diagnosis for which participation in this trial is either inappropriate or dangerous
  • Is severely suicidal (has ideation, plan, and intent)
  • Is currently receiving or planning to begin psychotherapy during the study treatment period
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01906476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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