Clinical trial NCT03143634: The Modular Protocol for Mental Health (MPMH)
Official title: The Modular Protocol for Mental Health (MPMH): A Pilot Randomised Clinical Trial of a Transdiagnostic Psychological Treatment for Mood and Anxiety Disorders in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Generalized Anxiety Disorder
Posttraumatic Stress Disorder
Social Anxiety Disorder
Panic Disorder
Agoraphobia
Obsessive-Compulsive Disorder
Illness Anxiety Disorder
Lead sponsor: Medical Research Council Cognition and Brain Sciences Unit
Sponsor class: OTHER_GOV
Collaborators: name: Cambridgeshire and Peterborough NHS Foundation Trust
First posted: 2017-05-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Depression symptoms
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in Anxiety symptoms
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in Level of disability and functional impairment
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Secondary outcomes:
measure: Change in symptoms of social phobia, agoraphobia and specific phobia
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of social anxiety
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of generalised anxiety
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of obsessive-compulsive disorder
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of post-traumatic stress disorder
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of agoraphobia
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of specific phobias
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of panic disorder
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in symptoms of illness anxiety
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in level of disability and functional impairment
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in expectancy about treatment outcome, as well as the credibility of the treatment
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in ability to contextualize negative events within a wider frame of reference
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in disengagement from and acceptance of troublesome mental content, rumination
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Intensity with which participants experience 36 different emotions on a typical day
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in use of NHS services, other mental health services or activities, help at home, and time off work/lost income
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
measure: Change in quality of life assessment of health and wellbeing, daily functioning, and general life satisfaction across multiple domains
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Other outcomes:
measure: Change in measure of memory specificity
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
measure: Change in cognitive flexibility for emotional information
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
measure: Change in immediate recall and working memory for neutral information
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
measure: Change in brief measure of premorbid intelligence
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
measure: Change in emotional structure (awareness and differentiation)
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
measure: Change in potential neurobiomarkers that may account for risk of disorders and/or predict treatment response (optional component of participation)
timeFrame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
measure: Change in levels of rumination
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in ability to tolerate distress
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in ability to label, perceive, and regulate emotions
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in negative beliefs, thoughts and assumptions
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in mindful awareness
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in fear of physical anxiety sensations
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in trauma-related beliefs and maladaptive appraisals of intrusive symptoms
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in implementation of cognitive therapy skills
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
measure: Change in avoidance of internal experiences including thoughts, feelings, physical sensations.
timeFrame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Locations:
city: Cambridge
country: United Kingdom
facility: MRC Cognition and Brain Sciences Unit
Study officials:
affiliation: Medical Research Council Cognition and Brain Sciences Unit
name: Tim Dalgleish, PhD
role: PRINCIPAL_INVESTIGATOR
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