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The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Clinical Trial

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Inquiry Based Stress Reduction (IBSR)
Cognitive Behavioral Therapy (CBT)
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Treatment, IBSR, CBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 years and older,
  • Not making use of other treatment for depression at the time,
  • No history of psychotherapy in the last year,
  • No medication for depression or unchanged dosage of medication during the last two months ,
  • All participants must be willing to refrain from engaging in additional psychological treatments or making changes to their medication status during the course of the trial. (changes in medication dosage will result in dropout),
  • All participants must have at least a low average level of intelligence (IQ above 80). During regular intakes a clinical judgment is made. This is in accordance with the standard protocols used within the FortaGroep.
  • All participants are required to have sufficient knowledge of the Dutch language.

Exclusion Criteria:

  • Active suicidal intent (which is asked during the interviews and further operationalized with help of the ninth item in the BDI-II at pre-treatment: If patients marked the statement ''I would kill myself if I could'', they are classified as being at risk of suicide)
  • If the DSM-IV criteria for severe major depressive disorder, psychotic disorder, or bipolar disorder are met
  • A mental impairment or neurocognitive disorders such as Alzheimer
  • Substance abuse requiring specialist treatment
  • No time for homework.

Sites / Locations

  • FortaGroep

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inquiry Based stress Reduction (IBSR)

Cognitive Behavioral Therapy (CBT)

Arm Description

IBSR intervention is the clinical implementation of a mindful-process, named "The Work" developed by Byron Katie. It teaches the individual to identify and question the thoughts that causes stress and suffering through four questions and turnarounds.

CBT is a psychological treatment method, focusing on a structured way to identify and modify unhelpful thinking patterns, underlying assumptions and idiosyncratic cognitive schemes about the self, the world (including other people) and the future.

Outcomes

Primary Outcome Measures

Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 16 sessions) and follow-ups.
The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. The investigators use the BDI-II to measure self-reported symptoms of depression.

Secondary Outcome Measures

Symptom Questionnaire (SQ-48) to measure change in self-reported general psychological distress from baseline at session 8, session 16 (end of therapy) and follow-ups
The SQ-48 is a self-report questionnaire which measures general psychological distress, vitality/optimism and work functioning. The subscales of this questionnaire include: Depression, Anxiety, Somatization, Agoraphobia, Aggression, Cognitive problems, Social Phobia, Work functioning and Vitality. The investigators use the SQ-48 to measure general psychological distress.
Short Form Health Survey (SF-36) to measure change from baseline self-reported quality of life at the endpoint of the therapy (after completing 16 sessions) and follow-ups
The SF-36 is a self-report questionnaire which measures quality of life. It consists of 36 items on well-being and functional, mental and physical health. The investigators use the SF-36 to measure quality of life.
The Structured Clinical Interview for Diagnostic and Statistical Manual-IV (DSM-IV) Axis I Disorders (SCID-I) Dutch version to screen for Diagnostic and Statistical Manual of Mental Disorder (DSM-IV) diagnoses
This structured interview is used to determine DSM-IV Axis I disorders. The investigators use the SCID-I to check in- and exclusion criteria, and to determine change in diagnosis after therapy.
Acceptance and Action Questionnaire-II (AAQ-II) to measure change in self-reported level of general psychological acceptance from baseline at every fourth therapy session and follow-ups
The AAQ-II is a self-report questionnaire which measures the psychological acceptance component of psychological flexibility. The investigators use the AAQ-II to measure the level of general psychological acceptance.
Dysfunctional Attitude Scale, 17-item Dutch version (DAS-A-17) to measure change in self-reported level of dysfunctional thinking from baseline at every fourth therapy session and follow-ups
The DAS-A-17 is a self-report scale designed to measures the respondent's use of typical depressive assumptions. The investigators use the DAS-A-17 to measure the level of dysfunctional thinking.
Behavioral activation for depression scale (BADS) to measure change in self-reported level of activation from baseline at every fourth therapy session and follow-ups
The short version of the BADS is a self-report questionnaire which measures the amount of activation in the past week. The investigators use the BADS to measure the level of activation.
State-Trait Anxiety Inventory, version: Y (STAI-form Y) to measure the level of anxiety at baseline
The STAI assesses current and trait anxiety symptoms. The investigators use the STAI to measure anxiety at baseline.
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at every fourth therapy session

Full Information

First Posted
September 2, 2015
Last Updated
September 12, 2018
Sponsor
Erasmus Medical Center
Collaborators
FortaGroep
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1. Study Identification

Unique Protocol Identification Number
NCT02542618
Brief Title
The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Clinical Trial
Official Title
The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
FortaGroep

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Major depression is a common mental disorder with serious consequences. The societal costs of depression are high. Despite the existence of empirically-supported psychological therapies, many patients do not benefit from these treatments and relapse and recurrence percentages are high. Improvement of existing treatments or development of new and better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising verbal therapy focusing on the inquiry of thoughts and could be a next step in improving psychotherapy for depression. Objective: The objective of the current study is to assess the effectiveness of IBSR. Research to date has shown that IBSR is effective in reducing symptoms of anxiety and depression. The investigators want to know if IBSR is more effective in reducing symptoms of depression than the best psychotherapeutic treatment for depression at this moment, cognitive behavioural therapy (CBT). The investigators' secondary objective is to know more about the underlying mechanisms of change of these therapies. Study design: A randomized controlled intervention study. Study population: 88 patients with a mild to moderate depression as their principal diagnosis. Intervention: IBSR or CBT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Treatment, IBSR, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inquiry Based stress Reduction (IBSR)
Arm Type
Experimental
Arm Description
IBSR intervention is the clinical implementation of a mindful-process, named "The Work" developed by Byron Katie. It teaches the individual to identify and question the thoughts that causes stress and suffering through four questions and turnarounds.
Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Active Comparator
Arm Description
CBT is a psychological treatment method, focusing on a structured way to identify and modify unhelpful thinking patterns, underlying assumptions and idiosyncratic cognitive schemes about the self, the world (including other people) and the future.
Intervention Type
Behavioral
Intervention Name(s)
Inquiry Based Stress Reduction (IBSR)
Other Intervention Name(s)
The Work
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Primary Outcome Measure Information:
Title
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 16 sessions) and follow-ups.
Description
The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. The investigators use the BDI-II to measure self-reported symptoms of depression.
Time Frame
At pre (baseline) and session 16 (post) and follow-up (after 1 and 2 years) measurements.
Secondary Outcome Measure Information:
Title
Symptom Questionnaire (SQ-48) to measure change in self-reported general psychological distress from baseline at session 8, session 16 (end of therapy) and follow-ups
Description
The SQ-48 is a self-report questionnaire which measures general psychological distress, vitality/optimism and work functioning. The subscales of this questionnaire include: Depression, Anxiety, Somatization, Agoraphobia, Aggression, Cognitive problems, Social Phobia, Work functioning and Vitality. The investigators use the SQ-48 to measure general psychological distress.
Time Frame
At pre (baseline), session 8 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Title
Short Form Health Survey (SF-36) to measure change from baseline self-reported quality of life at the endpoint of the therapy (after completing 16 sessions) and follow-ups
Description
The SF-36 is a self-report questionnaire which measures quality of life. It consists of 36 items on well-being and functional, mental and physical health. The investigators use the SF-36 to measure quality of life.
Time Frame
At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
Title
The Structured Clinical Interview for Diagnostic and Statistical Manual-IV (DSM-IV) Axis I Disorders (SCID-I) Dutch version to screen for Diagnostic and Statistical Manual of Mental Disorder (DSM-IV) diagnoses
Description
This structured interview is used to determine DSM-IV Axis I disorders. The investigators use the SCID-I to check in- and exclusion criteria, and to determine change in diagnosis after therapy.
Time Frame
At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
Title
Acceptance and Action Questionnaire-II (AAQ-II) to measure change in self-reported level of general psychological acceptance from baseline at every fourth therapy session and follow-ups
Description
The AAQ-II is a self-report questionnaire which measures the psychological acceptance component of psychological flexibility. The investigators use the AAQ-II to measure the level of general psychological acceptance.
Time Frame
At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Title
Dysfunctional Attitude Scale, 17-item Dutch version (DAS-A-17) to measure change in self-reported level of dysfunctional thinking from baseline at every fourth therapy session and follow-ups
Description
The DAS-A-17 is a self-report scale designed to measures the respondent's use of typical depressive assumptions. The investigators use the DAS-A-17 to measure the level of dysfunctional thinking.
Time Frame
At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Title
Behavioral activation for depression scale (BADS) to measure change in self-reported level of activation from baseline at every fourth therapy session and follow-ups
Description
The short version of the BADS is a self-report questionnaire which measures the amount of activation in the past week. The investigators use the BADS to measure the level of activation.
Time Frame
At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Title
State-Trait Anxiety Inventory, version: Y (STAI-form Y) to measure the level of anxiety at baseline
Description
The STAI assesses current and trait anxiety symptoms. The investigators use the STAI to measure anxiety at baseline.
Time Frame
At pre (baseline)
Title
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at every fourth therapy session
Time Frame
At pre (baseline), session 4,8, 12 and 16 (post).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years and older, Not making use of other treatment for depression at the time, No history of psychotherapy in the last year, No medication for depression or unchanged dosage of medication during the last two months , All participants must be willing to refrain from engaging in additional psychological treatments or making changes to their medication status during the course of the trial. (changes in medication dosage will result in dropout), All participants must have at least a low average level of intelligence (IQ above 80). During regular intakes a clinical judgment is made. This is in accordance with the standard protocols used within the FortaGroep. All participants are required to have sufficient knowledge of the Dutch language. Exclusion Criteria: Active suicidal intent (which is asked during the interviews and further operationalized with help of the ninth item in the BDI-II at pre-treatment: If patients marked the statement ''I would kill myself if I could'', they are classified as being at risk of suicide) If the DSM-IV criteria for severe major depressive disorder, psychotic disorder, or bipolar disorder are met A mental impairment or neurocognitive disorders such as Alzheimer Substance abuse requiring specialist treatment No time for homework.
Facility Information:
Facility Name
FortaGroep
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3067GK
Country
Netherlands

12. IPD Sharing Statement

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The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Clinical Trial

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