Comparing Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
Primary Purpose
Depression
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Emotion-Focused Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Moderate or major depressive episode as primary diagnosis
Exclusion Criteria:
- Serious mental illness (schizophrenia, severe bipolar disorder, recent or current psychotic episode) or intellectual disability.
- Severe alcohol or drug abuse, last 12 months.
- Suicidality last 6 months
- Severe medical issues
- If the participant is on antidepressive medication, the dosage must have been stable for more than 4 weeks, and the participant must consent to staying on the same dosage for the duration of the treatment.
- The participant is currently in another treatment for depression
Sites / Locations
- Institutt for Psykologisk rådgivningRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cognitive Behavioral Therapy
Emotion-Focused Therapy
Arm Description
14-18 sessions of psychotherapy according to principles of Cognitive Behavioral Therapy
14-18 sessions of psychotherapy according to principles of Emotion Focused Therapy
Outcomes
Primary Outcome Measures
Change in Beck Depression Inventory from session to session
Self-report measure of depressive symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.
Secondary Outcome Measures
Change in Beck Anxiety Inventory
Self-report measure of anxiety symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.
Change in Repetitive Eating Questionnaire
Self-report measure of symptoms related to eating disorders, average scores, minimum 0, maximum 6, higher score indicates worse outcome.
Change in Inventory of Interpersonal problems
Self-report measure of interpersonal difficulties, average scores minimum 0, maximum 4. Higher score suggests worse outcome.
Change in The Acceptance and Action Questionnaire from session to session
Self-report measure of psychological flexibility, average scores minimum 1, maximum 7. Higher score suggests worse outcome.
Change in Emotion Approach Coping Scale
Self-report measure of emotional processing ability, average scores minimum 1, maximum 4. Higher score suggests better outcome.
Change in Penn State Worry Questionaire
Self-report measure of rumination and cognitive processing, total scores minimum 16, maximum 80. Higher score suggests worse outcome.
Change in Self-Compassion Scale
Self-report measure of self-relating, average scores, minimum 1, maximum 5, higher scores suggests better outcome.
Change in Quality of life questionnaire
Self-report measure of quality of life, average scores, minimum 1, maximum 5, higher scores indicate better outcome.
Change in Working Alliance Inventory - short version
Self report measure on experience of therapeutic alliance, average scores, minimum 1, maximum 7, higher scores suggests better outcome.
Full Information
NCT ID
NCT04690946
First Posted
December 16, 2020
Last Updated
March 20, 2023
Sponsor
Institutt for Psykologisk Radgivning
Collaborators
University of Bergen
1. Study Identification
Unique Protocol Identification Number
NCT04690946
Brief Title
Comparing Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
Official Title
Randomized Controlled Study Comparing the Therapeutic Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institutt for Psykologisk Radgivning
Collaborators
University of Bergen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Depression is a common mental illness which is costly for both society and for those affected. There is a need for effective treatments of depression and there is a need to make sure that the treatments that are given are based on scientific findings. In this study the investigators want to examine and compare two common treatment models for depression - Cognitive Behavioral Therapy and Emotion-Focused Therapy. The investigators want to investigate what characterizes these treatments when they are successful, and seek to better understand what it is like for patients to receive these treatments. Also, the investigators will investigate the experience of patients who abruptly discontinue treatment. To investigate these questions, self-report measures, interviews and analysis of session recordings will be used.
Detailed Description
Depression is a widespread mental disorder which can result in severe impairment and reduced quality of life for those affected. Cognitive behavioral therapy (CBT) is the approach with strongest empirical support, and is often recommended as treatment for depression, as in the NICE Guidelines for Depression from 2009. However, research indicates that not all patients respond to CBT, indicating a need to expand the range of available evidence-based psychotherapies, and mapping the mechanisms of change in existing treatments.
Emotion focused therapy (EFT) is one promising treatment for depression with empirical support for its efficacy. A previous study found equal outcome in CBT and Process-Experiential treatment/EFT for depression, but more studies are needed to replicate these findings across cultural contexts. The main aim of this study is to investigate whether there are significant differences in the therapeutic effect of EFT compared to that of CBT for patients with moderate and major depressive disorder in a Norwegian outpatient setting.
Although several psychotherapeutic approaches have shown efficacy in the treatment of depression, no psychotherapeutic interventions is beneficial for all patients. There is a need for research that investigates what treatments works for whom, based on patient characteristics and preferences. The present study will investigate whether patient characteristics moderate treatment outcome, both within and between treatment conditions. In addition, qualitative interviews will be conducted to get a deeper understanding of what clients find helpful and challenging within the CBT and EFT condition, and to explore the experience of patients who drop-out of the treatment process.
In order to further develop psychotherapeutic treatments and increase their effectiveness, there is a need to identify processes that are related to good and poor outcome. Process-outcome studies are commonly used for this purpose. The present study will investigate and compare characteristics of psychotherapy processes in both the CBT and EFT conditions and how these are related to outcome.
Study design and Method
The study will be conducted as a randomized controlled trial (RCT) in order to compare the efficacy of EFT to CBT. RCT's are considered the gold standard for efficacy studies. Participants will be recruited from the Norwegian mental health program "Return to work", a publicly funded treatment program where patients with common mental health issues receives outpatient psychotherapeutic treatment to reduce and prevent sick leave.
The present study will address the following research hypothesis and questions:
EFT and CBT will not result in significantly different outcome in the treatment of patients with moderate and major depressive disorder.
Patient characteristics (severity of depression, adverse childhood experiences and clients' initial ability to make sense of their experience) will moderate treatment outcome for both conditions.
Will therapeutic processes (therapeutic alliance, therapist empathy, clients' ability to make sense of their experience and emotional processing) mediate treatment outcome equally for both conditions?
What do patients in both conditions describe as helpful and unhelpful aspects of treatment?
How do patients in both conditions describe their own change or lack or change after treatment?
How do patients that choose to drop out of treatment describe the processes leading to that decision?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
14-18 sessions of psychotherapy according to principles of Cognitive Behavioral Therapy
Arm Title
Emotion-Focused Therapy
Arm Type
Active Comparator
Arm Description
14-18 sessions of psychotherapy according to principles of Emotion Focused Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
14-18 sessions of CBT
Intervention Type
Behavioral
Intervention Name(s)
Emotion-Focused Therapy
Other Intervention Name(s)
EFT
Intervention Description
14-18 sessions of EFT
Primary Outcome Measure Information:
Title
Change in Beck Depression Inventory from session to session
Description
Self-report measure of depressive symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.
Time Frame
1 week before treatment startup, 1 day after each therapy session, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Secondary Outcome Measure Information:
Title
Change in Beck Anxiety Inventory
Description
Self-report measure of anxiety symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.
Time Frame
1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in Repetitive Eating Questionnaire
Description
Self-report measure of symptoms related to eating disorders, average scores, minimum 0, maximum 6, higher score indicates worse outcome.
Time Frame
1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in Inventory of Interpersonal problems
Description
Self-report measure of interpersonal difficulties, average scores minimum 0, maximum 4. Higher score suggests worse outcome.
Time Frame
1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in The Acceptance and Action Questionnaire from session to session
Description
Self-report measure of psychological flexibility, average scores minimum 1, maximum 7. Higher score suggests worse outcome.
Time Frame
1 week before treatment startup, 1 day after each therapy session, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in Emotion Approach Coping Scale
Description
Self-report measure of emotional processing ability, average scores minimum 1, maximum 4. Higher score suggests better outcome.
Time Frame
1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in Penn State Worry Questionaire
Description
Self-report measure of rumination and cognitive processing, total scores minimum 16, maximum 80. Higher score suggests worse outcome.
Time Frame
1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in Self-Compassion Scale
Description
Self-report measure of self-relating, average scores, minimum 1, maximum 5, higher scores suggests better outcome.
Time Frame
1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in Quality of life questionnaire
Description
Self-report measure of quality of life, average scores, minimum 1, maximum 5, higher scores indicate better outcome.
Time Frame
1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up
Title
Change in Working Alliance Inventory - short version
Description
Self report measure on experience of therapeutic alliance, average scores, minimum 1, maximum 7, higher scores suggests better outcome.
Time Frame
1 day after 1st through 14th therapy session.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Moderate or major depressive episode as primary diagnosis
Exclusion Criteria:
Serious mental illness (schizophrenia, severe bipolar disorder, recent or current psychotic episode) or intellectual disability.
Severe alcohol or drug abuse, last 12 months.
Suicidality last 6 months
Severe medical issues
If the participant is on antidepressive medication, the dosage must have been stable for more than 4 weeks, and the participant must consent to staying on the same dosage for the duration of the treatment.
The participant is currently in another treatment for depression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan R Stiegler, PhD
Phone
+4792211019
Email
stiegler@ipr.no
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Aardal, Cand Psychol
Phone
+4795287217
Email
aardal@ipr.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Reidar Stiegler, PhD
Organizational Affiliation
Institute for Psychological Counselling
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institutt for Psykologisk rådgivning
City
Bergen
ZIP/Postal Code
5012
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan R Stiegler, PhD
Phone
+4792211019
Email
stiegler@ipr.no
First Name & Middle Initial & Last Name & Degree
Hanna Aardal, Cand Psychol
Phone
+4795287217
Email
aardal@ipr.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparing Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
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