The Modular Protocol for Mental Health (MPMH): A Pilot Randomised Clinical Trial of a Transdiagnostic Psychological Treatment for Mood and Anxiety Disorders in Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in Depression symptoms
研究概览
简要总结
Currently, our best psychological treatments for anxiety and mood disorders only focus on individual diagnoses. So, there are separate treatments for Panic Disorder, or Depressive Disorder, or Social Anxiety, etc. These 'diagnosis-specific' treatments work well for people whose problems fit neatly into a single diagnosis. However, they work far less well for people with complex problems involving multiple diagnoses, and 50% of patients fail to respond well to these existing treatments.
The purpose of this study is to test a new psychological treatment for anxiety and mood problems (the Modular Protocol for Mental Health [MPMH]). Instead of focusing on any single diagnosis, MPMH combines the best treatment techniques into 10 modules to target problems common across all of the different mood and anxiety diagnoses (e.g., intense emotions, negative thinking, upsetting memories, distressing habits). MPMH should therefore be a better treatment for the large numbers of individuals whose problems do not fit neatly into a single diagnosis and for whom any treatments targeting a single diagnosis would leave significant difficulties unaddressed.
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
- Single (Outcomes Assessor)
盲法说明
Only the outcome assessor will be masked, as this is a psychological intervention it is not possible to mask the participant, care provider or investigator.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a primary diagnosis of a unipolar mood, anxiety, stress or obsessive-compulsive disorder with at least one additional comorbid diagnosis according to the DSM-
- •The criteria for diagnosis will be based on the Structured Clinical Interview for the DSM (SCID) which assesses disorders according to DSM-5 diagnostic criteria.
- •To be eligible participants will also need to score >10 on either the Patient Health Questionnaire (PHQ-9) or Generalised Anxiety Disorder -7 item scale, GAD-7 (see Study Measures above).
排除标准
- •Current/past psychosis or bipolar disorder
- •Current full diagnosis of substance use disorder
- •Organic brain damage
- •Complex trauma history or recurrent self-injury requiring specialist services (as deemed by the NHS Clinical Care team)
- •Current suicidality that warrants immediate clinical attention and constitutes a current risk of harm to the individual.
研究组 & 干预措施
The Modular Protocol for Mental Health
The Modular Protocol for Mental Health (Psychological Therapy) will last up to 18 regular weekly face-to-face sessions. Treatment follows a standard structured treatment session as per Cognitive Behavioural Therapy. The MPMH Treatment Manual was written by clinical psychologists. The selection and ordering of the modules for treatment will be delivered and determined by the Trial Clinical Psychologist in collaboration with the service-user. The treatment modules include:
M1. Getting Acquainted M2. Understanding Emotions M3. Managing and Tolerating Emotions M4. Behavioural activation M5. Tackling Avoidance M6. Tackling Unhelpful Thoughts M7. Tackling Unhelpful Habits M8. Overcoming Repetitive Thinking M9. Managing Upsetting Memories and Images M10. Relapse Prevention and Future Orientation
干预措施: The Modular Protocol for Mental Health (Behavioral)
Treatment-as-usual
For Treatment-as-usual (Psychological Therapy), clinicians will be asked to provide whatever treatment they deem appropriate, including psychological services, medication and referral to other services. TAU will be delivered by high-intensity therapists or clinical psychologists.
干预措施: Treatment-as-usual (Behavioral)
结局指标
主要结局
Change in Depression symptoms
时间窗: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Patient Health Questionnaire - 9-item version (PHQ-9; Kroenke \& Spitzer, 2002)
Change in Anxiety symptoms
时间窗: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
General Anxiety Disorder Questionnaire - 7-item version (GAD-7; Spitzer, Kroenke, Williams, \& Lowe, 2006)
Change in Level of disability and functional impairment
时间窗: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Work and Social Adjustment Scale (WSAS; Mundt, J.C. et al., 2002)
次要结局
- Change in symptoms of social phobia, agoraphobia and specific phobia(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of generalised anxiety(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of obsessive-compulsive disorder(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of specific phobias(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of panic disorder(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in disengagement from and acceptance of troublesome mental content, rumination(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in use of NHS services, other mental health services or activities, help at home, and time off work/lost income(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of agoraphobia(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of illness anxiety(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in expectancy about treatment outcome, as well as the credibility of the treatment(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in quality of life assessment of health and wellbeing, daily functioning, and general life satisfaction across multiple domains(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in level of disability and functional impairment(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in ability to contextualize negative events within a wider frame of reference(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Intensity with which participants experience 36 different emotions on a typical day(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of social anxiety(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)
- Change in symptoms of post-traumatic stress disorder(Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session)