The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Inquiry Based Stress Reduction (IBSR) (Behavioral)
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.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- State-Trait Anxiety Inventory, version: Y (STAI-form Y) to measure the level of anxiety at baseline(At pre (baseline))
- 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.)
- 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(At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.)
- Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at every fourth therapy session(At pre (baseline), session 4,8, 12 and 16 (post).)
研究者
Ingmar Franken
Professor of Clinical Psychology
Erasmus Medical Center