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

This study has been completed.
Sponsor:
Collaborators:
National Distance Education University (UNED)
University of Minho
University of Hertfordshire
University of Bern
University Ramon Llull
Institut Trastorn Límit
Hospital de Mataró
Fundació Institut de Recerca de l
Associació Centre de Salut Mental Nou Barris
Fundacion IMIM
EAP Poble Sec
Associació Catalana de Terapies Cognitives
Sant Pere Claver Fundació Sanitaria
Information provided by (Responsible Party):
Dr. Guillem Feixas, University of Barcelona
ClinicalTrials.gov Identifier:
NCT01542957
First received: February 26, 2012
Last updated: October 25, 2016
Last verified: October 2016
Results First Received: October 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Major Depressive Disorder
Dysthymic Disorder
Interventions: Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy
Behavioral: Cognitive Behavioral Therapy for Depression

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cognitive Behavioral + Dilemma Therapy

Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention

Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.

Cognitive Behavioral Therapy

Combined Group and Individual Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.


Participant Flow:   Overall Study
    Cognitive Behavioral + Dilemma Therapy   Cognitive Behavioral Therapy
STARTED   65   63 
COMPLETED   53   53 
NOT COMPLETED   12   10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cognitive Behavioral + Dilemma Therapy

Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention

Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.

Cognitive Behavioral Therapy

Combined Group and Individual Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.

Total Total of all reporting groups

Baseline Measures
   Cognitive Behavioral + Dilemma Therapy   Cognitive Behavioral Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   63   128 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.37  (11.22)   50.06  (11.03)   49.20  (11.19) 
Gender 
[Units: Participants]
Count of Participants
     
Female      51  78.5%      48  76.2%      99  77.3% 
Male      14  21.5%      15  23.8%      29  22.7% 


  Outcome Measures
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1.  Primary:   Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy   [ Time Frame: End of therapy (16 weeks) ]

2.  Secondary:   Change From Baseline in Hamilton-Depression Rating Scale-17 Items   [ Time Frame: End of therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Guillem Feixas
Organization: Universitat de Barcelona
phone: 0034 933125100
e-mail: gfeixas@ub.edu


Publications of Results:
Other Publications:

Responsible Party: Dr. Guillem Feixas, University of Barcelona
ClinicalTrials.gov Identifier: NCT01542957     History of Changes
Other Study ID Numbers: dilemma2012
PSI2011-23246 ( Other Grant/Funding Number: Ministry of Science and Innovation (Spanish Government) )
Study First Received: February 26, 2012
Results First Received: October 25, 2016
Last Updated: October 25, 2016