The Modular Protocol for Mental Health (MPMH)

Study Overview
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Brief Summary
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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.

Official Title
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The Modular Protocol for Mental Health (MPMH): A Pilot Randomised Clinical Trial of a Transdiagnostic Psychological Treatment for Mood and Anxiety Disorders in Adults

Conditions
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Major Depressive Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Illness Anxiety Disorder

Intervention / Treatment
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* Behavioral: The Modular Protocol for Mental Health
* Behavioral: Treatment-as-usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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-5. 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Modular Protocol for Mental Health<br>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 | Behavioral: The Modular Protocol for Mental Health<br>* This intervention is based on evidence-based cognitive-behavioural approaches to psychological disorders and offers a flexible approach to treatment delivery that targets the maladaptive processes common to mood and anxiety disorders.<br>|
| Placebo Comparator: Treatment-as-usual<br>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. | Behavioral: Treatment-as-usual<br>* This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression symptoms | Patient Health Questionnaire - 9-item version (PHQ-9; Kroenke & Spitzer, 2002) | Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session | 
| Change in Anxiety symptoms | General Anxiety Disorder Questionnaire - 7-item version (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006) | 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 | Work and Social Adjustment Scale (WSAS; Mundt, J.C. et al., 2002) | Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms of social phobia, agoraphobia and specific phobia | IAPT Phobia Scales (Department of Health/IAPT, 2011). This measure will only be completed by participants with symptoms of social phobia, agoraphobia or 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 social anxiety | The Social Phobia Inventory (SPIN; Connor, Davidson, Churchill, Sherwood, Foa, & Weisler, 2000). This measure will only be completed by participants with 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 generalised anxiety | The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990). This measure will only be completed by participants with symptoms of generalised anxiety 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 obsessive-compulsive disorder | The Obsessive-Compulsive Inventory (OCI; Foa, Kozak, Salkovskis, Coles, & Amir, 1998). This measure will only be completed by participants with 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 post-traumatic stress disorder | The Revised Impact of Event Scale (IES-R; Weiss, 2007). This measure will only be completed by participants with symptoms of PTSD. | 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 | The Agoraphobia-Mobility Inventory (MI; Chambless, Caputo, Jasin, Gracely, & Williams, 1985). This measure will only be completed by participants with 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 specific phobias | The Fear Questionnaire (FQ; Marks & Mathews, 1979). This measure will only be completed by participants with symptoms of 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 panic disorder | The Panic Disorder Severity Scale - self report version (PDSS-SR; Shear, Brown, Barlow, Money, Sholomskas, Woods, Gorman, & Papp, 1997). This measure will only be completed by participants with 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 symptoms of illness anxiety | The Health Anxiety Inventory - short version (SHAI; Salkovskis, Rimes, Warwick, & Clark, 2002). This measure will only be completed by participants with 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 level of disability and functional impairment | Sheehan Disability Scale (SDS; Sheehan, 1983) | 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 | The Treatment Credibility / Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000) | 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 | Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2000) | 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 | Experiences Questionnaire (EQ; Fresco et al., 2007) | 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 | Differential Emotions Scale (DES; Izard, 1993) | 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 | Levels of Personality Functioning Scale (LPFS; Morey et al., 2017) | 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 | Healthlines Resource Use Questionnaire (Salisbury, O'Cathain, Edwards, Thomas, Gaunt, Hollinghurst, et al., 2016) | 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 | World Health Organisation (WHO) Quality of Life Inventory (WHOQOL; World Health Organisation, 1998) | Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session |