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

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ClinicalTrials.gov Identifier: NCT01542957
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : December 19, 2016
Last Update Posted : March 22, 2017
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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
Enrollment 128

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Hide Arm/Group Description

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.

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.

Period Title: End of Therapy
Started 65 63
Completed 53 53
Not Completed 12 10
Period Title: 3-month Follow-up
Started 53 53
Completed 50 45
Not Completed 3 8
Period Title: 12-month Follow-up
Started 53 53
Completed 37 40
Not Completed 16 13
Arm/Group Title Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 65 63 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 63 participants 128 participants
48.37  (11.22) 50.06  (11.03) 49.20  (11.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 63 participants 128 participants
Female
51
  78.5%
48
  76.2%
99
  77.3%
Male
14
  21.5%
15
  23.8%
29
  22.7%
1.Primary Outcome
Title Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
Hide Description To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.
Time Frame End of therapy (16 weeks), 3 and 12-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified
Arm/Group Title Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 53 participants 53 participants
37.23  (8.96) 36.94  (9.56)
At the end of therapy change from baseline Number Analyzed 53 participants 53 participants
-17.62  (12.05) -15.52  (13.92)
3-month follow-up change from baseline Number Analyzed 50 participants 45 participants
-15.42  (13.16) -15.60  (15.56)
12-month follow-up change from baseline Number Analyzed 37 participants 40 participants
-19.51  (13.17) -16.65  (13.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral + Dilemma Therapy, Cognitive Behavioral Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-3.35 to 1.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Hamilton-Depression Rating Scale-17 Items
Hide Description This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.
Time Frame End of therapy and 12-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified.
Arm/Group Title Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 42 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 42 participants 38 participants
18.93  (6.96) 20.05  (6.09)
At the end of therapy change from baseline Number Analyzed 42 participants 38 participants
-7.61  (9.21) -8.84  (8.28)
12 month follow-up change from baseline Number Analyzed 31 participants 28 participants
-5.32  (9.56) -7.89  (9.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral + Dilemma Therapy, Cognitive Behavioral Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
-0.71 to 3.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: .53
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
Hide Description To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.
Time Frame End of therapy, 3 and 12 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified
Arm/Group Title Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 53 participants 53 participants
2.17  (0.50) 2.08  (0.56)
At the end of therapy change from baselina Number Analyzed 53 participants 53 participants
-0.76  (0.70) -0.67  (0.75)
3 month follow-up change from baseline Number Analyzed 50 participants 45 participants
-0.59  (0.76) -0.63  (0.80)
12 month follow-up change from baseline Number Analyzed 37 participants 40 participants
-0.77  (0.81) -0.58  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral + Dilemma Therapy, Cognitive Behavioral Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.14 to 0.12
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description "0" means that serious and other [non-serious] adverse events were not collected or assessed as part of the study since no detrimental effects were expected as result of psychotherapies.
 
Arm/Group Title Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Behavioral + Dilemma Therapy Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
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) )
First Submitted: February 26, 2012
First Posted: March 2, 2012
Results First Submitted: October 25, 2016
Results First Posted: December 19, 2016
Last Update Posted: March 22, 2017