The Modular Protocol for Mental Health (MPMH)

NCT03143634 | Completed Phase 1

• 1 other identifier: MP:MH RfPB PB-PG-0214-33072
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• 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 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

  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 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

Other Outcomes (15)

• Change in measure of memory specificity

  Baseline (within two weeks of first treatment session), within one week of the final treatment session

• Change in cognitive flexibility for emotional information

  Baseline (within two weeks of first treatment session), within one week of the final treatment session

• Change in immediate recall and working memory for neutral information

  Baseline (within two weeks of first treatment session), within one week of the final treatment session

Study Arms (2)

The Modular Protocol for Mental Health

EXPERIMENTAL

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

Treatment-as-usual

PLACEBO COMPARATOR

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

Interventions

The Modular Protocol for Mental Health BEHAVIORAL

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.

The Modular Protocol for Mental Health

Treatment-as-usual BEHAVIORAL

This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.

Treatment-as-usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Research Council Cognition and Brain Sciences Unit: lead
• Cambridgeshire and Peterborough NHS Foundation Trust: collaborator

Study Sites (1)

MRC Cognition and Brain Sciences Unit

Cambridge, CB2 7EF, United Kingdom

Location

Related Publications (38)

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MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder; Stress Disorders, Post-Traumatic; Phobia, Social; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Tim Dalgleish, PhD

  Medical Research Council Cognition and Brain Sciences Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 8, 2017
• Study Start: July 18, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

GB (1)