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

• Sponsor: University of Barcelona (Other)
• Overall Status: Completed
• CT.gov ID: NCT01542957
• Collaborator: National Distance Education University (UNED) (Other), University of Minho (Other), University of Hertfordshire (Other), University of Bern (Other), University Ramon Llull (Other), Institut Trastorn Límit (Other), Hospital de Mataró (Other), Fundació Institut de Recerca de l (Other), Associació Centre de Salut Mental Nou Barris (Other), Fundacion IMIM (Other), EAP Poble Sec (Other), Associació Catalana de Terapies Cognitives (Other), Sant Pere Claver Fundació Sanitaria (Other)
• Enrollment: 128
• Locations: 4
• Arms: 2
• Duration (Months): 42
• Patients Per Site: 32
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; Dysthymic Disorder	Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy; Behavioral: Cognitive Behavioral Therapy for Depression	N/A

Detailed Description

Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments most of the cases evolve with only partial remission, relapse and recurrence.

Cognitive models made a significant contribution in the understanding of unipolar depression and its psychological treatment. Even though, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence.

Our research group has been working in the notion of cognitive conflict viewed as personal dilemma according to personal construct theory. The investigators use a novel method for identifying those conflicts using the repertory grid technique. Preliminary results with depressive patients show that more than 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused in the resolution of these internal conflicts.

This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will contribute to enhance the efficacy of Cognitive-Behavioral Therapy for depression. A therapy manual for this approach will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: a CBT treatment package and another package combining cognitive-behavioral and dilemma-focused interventions. The investigators expect that this combined package will increase the efficacy of CBT, one of the more prestigious therapies for depression, this resulting in a significant contribution for its treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioral + Dilemma Therapy Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention	Behavioral: 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.; Other Names: Personal Construct Therapy
Active Comparator: Cognitive Behavioral Therapy Combined Group and Individual Cognitive Behavioral Therapy	Behavioral: 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.; Other Names: Cognitive Therapy

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up [End of therapy (16 weeks), 3 and 12-month follow-up]

   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.

Secondary Outcome Measures

1. Change From Baseline in Hamilton-Depression Rating Scale-17 Items [End of therapy and 12-month follow-up]

   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.

2. Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up [End of therapy, 3 and 12 month follow-up]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Mataro (Consorci Sanitari del Maresme)	Mataro	Barcelona	Spain	08304
2	CAP Les Hortes	Barcelona	Catalonia	Spain	08004
3	Fundació Sanitària Sant Pere Claver	Barcelona	Catalonia	Spain	08004
4	Associació Catalana de Teràpies Cognitives	Barcelona	Catalonia	Spain	08032

Sponsors and Collaborators

• University of Barcelona
• 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

Investigators

• Principal Investigator: Guillem Feixas, Ph.D., University of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Web page in Spanish and Catalan describing the research project and recruitment information

Publications

• Feixas G, Bados A, García-Grau E, Montesano A, Dada G, Compañ V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saúl-Gutiérrez LA, Cañete J, Gasol M, Ibarra M, Medeiros-Ferreira L, Soriano J, Ribeiro E, Caspar F, Winter D. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial. Trials. 2013 May 17;14:144. doi: 10.1186/1745-6215-14-144.

• Responsible Party: Dr. Guillem Feixas, Professor, University of Barcelona
• ClinicalTrials.gov Identifier: NCT01542957
• Other Study ID Numbers: dilemma2012; PSI2011-23246
• First Posted: Mar 2, 2012
• Last Update Posted: Mar 22, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Dr. Guillem Feixas, Professor, University of Barcelona: Major Depressive Disorder; Dysthymic Disorder; Depression; Cognitive Behavior Therapy; Personal Construct Theory; Repertory Grid Technique; Cognitive Conflicts; Personal dilemmas
• Additional relevant MeSH terms: Disease; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder

Study Results

Participant Flow

Arm/Group Title	Cognitive Behavioral + Dilemma Therapy	Cognitive Behavioral Therapy
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: End of Therapy
STARTED	53	53
COMPLETED	50	45
NOT COMPLETED	3	8
Period Title: End of Therapy
STARTED	53	53
COMPLETED	37	40
NOT COMPLETED	16	13

Baseline Characteristics

Arm/Group Title	Cognitive Behavioral + Dilemma Therapy	Cognitive Behavioral Therapy	Total
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 Participants	65	63	128
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.37 (11.22)	50.06 (11.03)	49.20 (11.19)
Sex: Female, Male (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

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
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

Outcome Measure Data

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
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.
Measure Participants	53	53
Baseline	37.23 (8.96)	36.94 (9.56)
At the end of therapy change from baseline	-17.62 (12.05)	-15.52 (13.92)
3-month follow-up change from baseline	-15.42 (13.16)	-15.60 (15.56)
12-month follow-up change from baseline	-19.51 (13.17)	-16.65 (13.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavioral + Dilemma Therapy, Cognitive Behavioral Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Mixed Models Analysis
	Comments
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

2. Secondary Outcome

Title	Change From Baseline in Hamilton-Depression Rating Scale-17 Items
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

Outcome Measure Data

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
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.
Measure Participants	42	38
Baseline	18.93 (6.96)	20.05 (6.09)
At the end of therapy change from baseline	-7.61 (9.21)	-8.84 (8.28)
12 month follow-up change from baseline	-5.32 (9.56)	-7.89 (9.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavioral + Dilemma Therapy, Cognitive Behavioral Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Mixed Models Analysis
	Comments
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

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
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

Outcome Measure Data

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
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.
Measure Participants	53	53
Baseline	2.17 (0.50)	2.08 (0.56)
At the end of therapy change from baselina	-0.76 (0.70)	-0.67 (0.75)
3 month follow-up change from baseline	-0.59 (0.76)	-0.63 (0.80)
12 month follow-up change from baseline	-0.77 (0.81)	-0.58 (0.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavioral + Dilemma Therapy, Cognitive Behavioral Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.14 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cognitive Behavioral + Dilemma Therapy		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Cognitive Behavioral + Dilemma Therapy		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.