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

• ClinicalTrials.gov Identifier: NCT02542618
• Recruitment Status: Unknown
• First Posted: September 7, 2015
• Last Update Posted: September 13, 2018
• Sponsor: Erasmus Medical Center
• Collaborator: FortaGroep
• Information provided by (Responsible Party): Ingmar Franken, Erasmus Medical Center

Tracking Information

• First Submitted Date: September 2, 2015
• First Posted Date: September 7, 2015
• Last Update Posted Date: September 13, 2018
• Study Start Date: October 2015
• Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2015)

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. [ Time Frame: At pre (baseline) and session 16 (post) and follow-up (after 1 and 2 years) measurements. ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 4, 2015)

• 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 [ Time Frame: At pre (baseline), session 8 and 16 (post) and follow-up (after 1 and 2 years) measurements. ]
  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 [ Time Frame: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements. ]
  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 [ Time Frame: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements. ]
  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 [ Time Frame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements. ]
  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 [ Time Frame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements. ]
  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 [ Time Frame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements. ]
  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 [ Time Frame: At pre (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 [ Time Frame: At pre (baseline), session 4,8, 12 and 16 (post). ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Depression

Intervention

• Behavioral: Inquiry Based Stress Reduction (IBSR)
  Other Name: The Work
• Behavioral: Cognitive Behavioral Therapy (CBT)

Study Arms

• Experimental: Inquiry Based stress Reduction (IBSR)
  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.
  Intervention: Behavioral: Inquiry Based Stress Reduction (IBSR)
• Active Comparator: Cognitive Behavioral Therapy (CBT)
  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: Behavioral: Cognitive Behavioral Therapy (CBT)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: September 4, 2015): 88
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2020
• Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02542618
• Other Study ID Numbers: NL51699.078.15
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ingmar Franken, Erasmus Medical Center
• Study Sponsor: Erasmus Medical Center
• Collaborators: FortaGroep
• Investigators: Not Provided
• PRS Account: Erasmus Medical Center
• Verification Date: September 2018