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

NCT02542618 | Unknown

• 1 other identifier: NL51699.078.15
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Keywords

Depression; Treatment; IBSR; CBT

Outcome Measures

Primary Outcomes (1)

• 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.

  At pre (baseline) and session 16 (post) and follow-up (after 1 and 2 years) measurements.

Secondary Outcomes (8)

• 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

  At pre (baseline), session 8 and 16 (post) and follow-up (after 1 and 2 years) measurements.

• 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

  At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.

• 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

  At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.

• 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

  At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.

• 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

  At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.

Study Arms (2)

Inquiry Based stress Reduction (IBSR)

EXPERIMENTAL

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.

Behavioral: Inquiry Based Stress Reduction (IBSR)

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Inquiry Based Stress Reduction (IBSR) BEHAVIORAL

Also known as: The Work

Inquiry Based stress Reduction (IBSR)

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• FortaGroep: collaborator

Study Sites (1)

FortaGroep

Rotterdam, South Holland, 3067GK, Netherlands

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 7, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: March 1, 2020
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

NL (1)