N/A N=128 Randomized Single-blind Treatment

Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention

Major Depressive Disorder · Dysthymic Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01542957 ↗

Enrolled (actual)

128

Serious AEs

—

Results posted

Dec 2016

Primary outcome: Primary: Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up — 37.23; 36.94; -17.62; -15.52 units on a scale — p=0.60

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Combined Cognitive Behavioral and Dilemma-Focused Therapy (Behavioral); Cognitive Behavioral Therapy for Depression (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Barcelona
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up	37.23; 36.94; -17.62; -15.52; -15.42; -15.60	0.60
SECONDARY Change From Baseline in Hamilton-Depression Rating Scale-17 Items	18.93; 20.05; -7.61; -8.84; -5.32; -7.89	0.21
SECONDARY Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up	2.17; 2.08; -0.76; -0.67; -0.59; -0.63	0.84

Summary

The purpose of this study is to determine the efficacy of a brief psychological intervention focused on the personal dilemmas identified for each depressive patient. For that, this intervention is combined to group cognitive therapy (an already proven efficacious format) and compared to cognitive individual therapy.

Eligibility Criteria

Inclusion Criteria

Meeting diagnostic criteria for Major Depressive Disorder (MDD) or Dysthymic Disorder (DD) according to the DSM-IV-TR (APA, 2002) criteria a assessed using SCID-I
A score above 19 on the BDI-II Questionnaire
Presenting at leat one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the Repertory Grid Technique
Enough level of competence to communicate in Spanish or Catalan

Exclusion Criteria

Bipolar disorders
Psychotic symptoms
Substance abuse
Organic brain dysfunction
Mental retardation
Serious suicidal ideation
Receiving psychological treatment (unless it is suspended at the time of inclusion in the study itself, in agreement with the patient and the practitioner applying it)
Substantial visual, hearing or cognitive deficits

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01542957). 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.