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The Modular Protocol for Mental Health (MPMH) (MPMH)

Primary Purpose

Major Depressive Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
The Modular Protocol for Mental Health
Treatment-as-usual
Sponsored by
Medical Research Council Cognition and Brain Sciences Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • MRC Cognition and Brain Sciences Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The Modular Protocol for Mental Health

Treatment-as-usual

Arm 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

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.

Outcomes

Primary Outcome Measures

Change in Depression symptoms
Patient Health Questionnaire - 9-item version (PHQ-9; Kroenke & Spitzer, 2002)
Change in Anxiety symptoms
General Anxiety Disorder Questionnaire - 7-item version (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)
Change in Level of disability and functional impairment
Work and Social Adjustment Scale (WSAS; Mundt, J.C. et al., 2002)

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in level of disability and functional impairment
Sheehan Disability Scale (SDS; Sheehan, 1983)
Change in expectancy about treatment outcome, as well as the credibility of the treatment
The Treatment Credibility / Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
Change in ability to contextualize negative events within a wider frame of reference
Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2000)
Change in disengagement from and acceptance of troublesome mental content, rumination
Experiences Questionnaire (EQ; Fresco et al., 2007)
Intensity with which participants experience 36 different emotions on a typical day
Differential Emotions Scale (DES; Izard, 1993)
Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy
Levels of Personality Functioning Scale (LPFS; Morey et al., 2017)
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)
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)

Full Information

First Posted
April 27, 2017
Last Updated
September 27, 2020
Sponsor
Medical Research Council Cognition and Brain Sciences Unit
Collaborators
Cambridgeshire and Peterborough NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03143634
Brief Title
The Modular Protocol for Mental Health (MPMH)
Acronym
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Research Council Cognition and Brain Sciences Unit
Collaborators
Cambridgeshire and Peterborough NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Illness Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Modular Protocol for Mental Health
Arm Type
Experimental
Arm 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
Arm Title
Treatment-as-usual
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
The Modular Protocol for Mental Health
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual
Intervention Description
This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.
Primary Outcome Measure Information:
Title
Change in Depression symptoms
Description
Patient Health Questionnaire - 9-item version (PHQ-9; Kroenke & Spitzer, 2002)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in Anxiety symptoms
Description
General Anxiety Disorder Questionnaire - 7-item version (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in Level of disability and functional impairment
Description
Work and Social Adjustment Scale (WSAS; Mundt, J.C. et al., 2002)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Secondary Outcome Measure Information:
Title
Change in symptoms of social phobia, agoraphobia and specific phobia
Description
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.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of social anxiety
Description
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.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of generalised anxiety
Description
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.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of obsessive-compulsive disorder
Description
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.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of post-traumatic stress disorder
Description
The Revised Impact of Event Scale (IES-R; Weiss, 2007). This measure will only be completed by participants with symptoms of PTSD.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of agoraphobia
Description
The Agoraphobia-Mobility Inventory (MI; Chambless, Caputo, Jasin, Gracely, & Williams, 1985). This measure will only be completed by participants with symptoms of agoraphobia.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of specific phobias
Description
The Fear Questionnaire (FQ; Marks & Mathews, 1979). This measure will only be completed by participants with symptoms of specific phobia.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of panic disorder
Description
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.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in symptoms of illness anxiety
Description
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.
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in level of disability and functional impairment
Description
Sheehan Disability Scale (SDS; Sheehan, 1983)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in expectancy about treatment outcome, as well as the credibility of the treatment
Description
The Treatment Credibility / Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in ability to contextualize negative events within a wider frame of reference
Description
Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2000)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in disengagement from and acceptance of troublesome mental content, rumination
Description
Experiences Questionnaire (EQ; Fresco et al., 2007)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Intensity with which participants experience 36 different emotions on a typical day
Description
Differential Emotions Scale (DES; Izard, 1993)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy
Description
Levels of Personality Functioning Scale (LPFS; Morey et al., 2017)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in use of NHS services, other mental health services or activities, help at home, and time off work/lost income
Description
Healthlines Resource Use Questionnaire (Salisbury, O'Cathain, Edwards, Thomas, Gaunt, Hollinghurst, et al., 2016)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Title
Change in quality of life assessment of health and wellbeing, daily functioning, and general life satisfaction across multiple domains
Description
World Health Organisation (WHO) Quality of Life Inventory (WHOQOL; World Health Organisation, 1998)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Other Pre-specified Outcome Measures:
Title
Change in measure of memory specificity
Description
Autobiographical Memory Test (Williams & Broadbent, 1986).
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session
Title
Change in cognitive flexibility for emotional information
Description
Affective Card Sorting Task (Barcelo, 2003; Deveney & Deldin, 2006)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session
Title
Change in immediate recall and working memory for neutral information
Description
Digit Span Task (Wechsler, 2008)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session
Title
Change in brief measure of premorbid intelligence
Description
National Adult Reading Test (Nelson & Wilson, 1991)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session
Title
Change in emotional structure (awareness and differentiation)
Description
Levels of Emotional Awareness Scale (Lane et al., 1990)
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session
Title
Change in potential neurobiomarkers that may account for risk of disorders and/or predict treatment response (optional component of participation)
Description
Functional connectivity during resting state MRI
Time Frame
Baseline (within two weeks of first treatment session), within one week of the final treatment session
Title
Change in levels of rumination
Description
Ruminative Responses Scale of the Response Styles Questionnaire (RRS; Treynor, Gonzalez, Nolen-Hoeksema, 2003)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in ability to tolerate distress
Description
Distress Tolerance Scale (DTS; Simons & Gaher, 2005)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in ability to label, perceive, and regulate emotions
Description
Difficulties with Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in negative beliefs, thoughts and assumptions
Description
Dysfunctional Attitudes Scale (DAS; Weissman, 1979)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in mindful awareness
Description
Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in fear of physical anxiety sensations
Description
Anxiety Sensitivity Index (ASI; Reiss, Peterson, Gursky, & McNally 1986)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in trauma-related beliefs and maladaptive appraisals of intrusive symptoms
Description
Posttraumatic cognitions inventory - short version (PTCI; Foa, Ehlers, Clark, Tolin, Orsillo, 1999)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in implementation of cognitive therapy skills
Description
Skills of Cognitive Therapy (SoCT; Jarrett, 2010)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Title
Change in avoidance of internal experiences including thoughts, feelings, physical sensations.
Description
The Multidimensional Experiential Avoidance Questionnaire (Gamez, Chmielewski, Kotov, Ruggero, & Watson, 2011)
Time Frame
Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Dalgleish, PhD
Organizational Affiliation
Medical Research Council Cognition and Brain Sciences Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRC Cognition and Brain Sciences Unit
City
Cambridge
ZIP/Postal Code
CB2 7EF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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