Comparing Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression

Sponsor
Institutt for Psykologisk Radgivning (Other)
Overall Status
Recruiting
CT.gov ID
NCT04690946
Collaborator
University of Bergen (Other)
120
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2
35.3
3.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: Emotion-Focused Therapy
N/A

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:
  1. EFT and CBT will not result in significantly different outcome in the treatment of patients with moderate and major depressive disorder.

  2. 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.

  3. 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?

  4. What do patients in both conditions describe as helpful and unhelpful aspects of treatment?

  5. How do patients in both conditions describe their own change or lack or change after treatment?

  6. How do patients that choose to drop out of treatment describe the processes leading to that decision?

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Clinical TrialRandomized Clinical Trial
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Study Comparing the Therapeutic Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
Actual Study Start Date :
Jan 20, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cognitive Behavioral Therapy

14-18 sessions of psychotherapy according to principles of Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy
14-18 sessions of CBT
Other Names:
  • CBT
  • Active Comparator: Emotion-Focused Therapy

    14-18 sessions of psychotherapy according to principles of Emotion Focused Therapy

    Behavioral: Emotion-Focused Therapy
    14-18 sessions of EFT
    Other Names:
  • EFT
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Beck Depression Inventory from session to session [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]

      Self-report measure of depressive symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.

    Secondary Outcome Measures

    1. Change in Beck Anxiety Inventory [1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up]

      Self-report measure of anxiety symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.

    2. Change in Repetitive Eating Questionnaire [1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up]

      Self-report measure of symptoms related to eating disorders, average scores, minimum 0, maximum 6, higher score indicates worse outcome.

    3. Change in Inventory of Interpersonal problems [1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up]

      Self-report measure of interpersonal difficulties, average scores minimum 0, maximum 4. Higher score suggests worse outcome.

    4. Change in The Acceptance and Action Questionnaire from session to session [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]

      Self-report measure of psychological flexibility, average scores minimum 1, maximum 7. Higher score suggests worse outcome.

    5. Change in Emotion Approach Coping Scale [1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up]

      Self-report measure of emotional processing ability, average scores minimum 1, maximum 4. Higher score suggests better outcome.

    6. Change in Penn State Worry Questionaire [1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up]

      Self-report measure of rumination and cognitive processing, total scores minimum 16, maximum 80. Higher score suggests worse outcome.

    7. Change in Self-Compassion Scale [1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up]

      Self-report measure of self-relating, average scores, minimum 1, maximum 5, higher scores suggests better outcome.

    8. Change in Quality of life questionnaire [1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up]

      Self-report measure of quality of life, average scores, minimum 1, maximum 5, higher scores indicate better outcome.

    9. Change in Working Alliance Inventory - short version [1 day after 1st through 14th therapy session.]

      Self report measure on experience of therapeutic alliance, average scores, minimum 1, maximum 7, higher scores suggests better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institutt for Psykologisk rÄdgivning Bergen Norway 5012

    Sponsors and Collaborators

    • Institutt for Psykologisk Radgivning
    • University of Bergen

    Investigators

    • Principal Investigator: Jan Reidar Stiegler, PhD, Institute for Psychological Counselling

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Institutt for Psykologisk Radgivning
    ClinicalTrials.gov Identifier:
    NCT04690946
    Other Study ID Numbers:
    • IPR
    First Posted:
    Dec 31, 2020
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022