The Modular Protocol for Mental Health (MPMH)

Medical Research Council Cognition and Brain Sciences Unit

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Behavioral: Treatment-as-usual; Behavioral: The Modular Protocol for Mental Health

Study type: Interventional

Funder types: Other

Identifiers

NCT03143634

MP:MH RfPB PB-PG-0214-33072

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups, including a placebo group

The Modular Protocol for Mental Health

Experimental group

Description:

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

Treatment:

Behavioral: The Modular Protocol for Mental Health

Treatment-as-usual

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Treatment-as-usual