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

Erasmus University

Status: Unknown

Conditions: Depression

Treatments: Behavioral: Inquiry Based Stress Reduction (IBSR); Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02542618

NL51699.078.15

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Inquiry Based stress Reduction (IBSR)

Experimental group

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.

Treatment:

Behavioral: Inquiry Based Stress Reduction (IBSR)

Cognitive Behavioral Therapy (CBT)

Active Comparator group

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)