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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03143634
Recruitment Status : Enrolling by invitation
First Posted : May 8, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Cambridgeshire and Peterborough NHS Foundation Trust
Information provided by (Responsible Party):
Medical Research Council Cognition and Brain Sciences Unit

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Generalized Anxiety Disorder Posttraumatic Stress Disorder Social Anxiety Disorder Panic Disorder Agoraphobia Obsessive-Compulsive Disorder Illness Anxiety Disorder Behavioral: The Modular Protocol for Mental Health Behavioral: Treatment-as-usual Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Treatment
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
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The Modular Protocol for Mental Health

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
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.

Placebo Comparator: Treatment-as-usual
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
This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.




Primary Outcome Measures :
  1. Change in Depression symptoms [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Patient Health Questionnaire - 9-item version (PHQ-9; Kroenke & Spitzer, 2002)

  2. Change in Anxiety symptoms [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    General Anxiety Disorder Questionnaire - 7-item version (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)

  3. Change in Level of disability and functional impairment [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Work and Social Adjustment Scale (WSAS; Mundt, J.C. et al., 2002)


Secondary Outcome Measures :
  1. Change in symptoms of social phobia, agoraphobia and 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 ]
    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.

  2. Change in 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 ]
    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.

  3. Change in symptoms of generalised 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 ]
    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.

  4. Change in 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 ]
    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.

  5. Change in symptoms of post-traumatic stress 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 ]
    The Revised Impact of Event Scale (IES-R; Weiss, 2007). This measure will only be completed by participants with symptoms of PTSD.

  6. Change in 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 ]
    The Agoraphobia-Mobility Inventory (MI; Chambless, Caputo, Jasin, Gracely, & Williams, 1985). This measure will only be completed by participants with symptoms of agoraphobia.

  7. Change in symptoms of specific phobias [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    The Fear Questionnaire (FQ; Marks & Mathews, 1979). This measure will only be completed by participants with symptoms of specific phobia.

  8. Change in 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 ]
    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.

  9. Change in 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 ]
    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.

  10. Change in level of disability and functional impairment [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Sheehan Disability Scale (SDS; Sheehan, 1983)

  11. Change in expectancy about treatment outcome, as well as the credibility of the treatment [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    The Treatment Credibility / Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)

  12. Change in ability to contextualize negative events within a wider frame of reference [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2000)

  13. Change in disengagement from and acceptance of troublesome mental content, rumination [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Experiences Questionnaire (EQ; Fresco et al., 2007)

  14. Intensity with which participants experience 36 different emotions on a typical day [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Differential Emotions Scale (DES; Izard, 1993)

  15. Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Levels of Personality Functioning Scale (LPFS; Morey et al., 2017)

  16. Change in use of NHS services, other mental health services or activities, help at home, and time off work/lost income [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    Healthlines Resource Use Questionnaire (Salisbury, O'Cathain, Edwards, Thomas, Gaunt, Hollinghurst, et al., 2016)

  17. Change in quality of life assessment of health and wellbeing, daily functioning, and general life satisfaction across multiple domains [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session ]
    World Health Organisation (WHO) Quality of Life Inventory (WHOQOL; World Health Organisation, 1998)


Other Outcome Measures:
  1. Change in measure of memory specificity [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session ]
    Autobiographical Memory Test (Williams & Broadbent, 1986).

  2. Change in cognitive flexibility for emotional information [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session ]
    Affective Card Sorting Task (Barcelo, 2003; Deveney & Deldin, 2006)

  3. Change in immediate recall and working memory for neutral information [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session ]
    Digit Span Task (Wechsler, 2008)

  4. Change in brief measure of premorbid intelligence [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session ]
    National Adult Reading Test (Nelson & Wilson, 1991)

  5. Change in emotional structure (awareness and differentiation) [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session ]
    Levels of Emotional Awareness Scale (Lane et al., 1990)

  6. Change in potential neurobiomarkers that may account for risk of disorders and/or predict treatment response (optional component of participation) [ Time Frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session ]
    Functional connectivity during resting state MRI

  7. Change in levels of rumination [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Ruminative Responses Scale of the Response Styles Questionnaire (RRS; Treynor, Gonzalez, Nolen-Hoeksema, 2003)

  8. Change in ability to tolerate distress [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Distress Tolerance Scale (DTS; Simons & Gaher, 2005)

  9. Change in ability to label, perceive, and regulate emotions [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Difficulties with Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

  10. Change in negative beliefs, thoughts and assumptions [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Dysfunctional Attitudes Scale (DAS; Weissman, 1979)

  11. Change in mindful awareness [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004)

  12. Change in fear of physical anxiety sensations [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Anxiety Sensitivity Index (ASI; Reiss, Peterson, Gursky, & McNally 1986)

  13. Change in trauma-related beliefs and maladaptive appraisals of intrusive symptoms [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Posttraumatic cognitions inventory - short version (PTCI; Foa, Ehlers, Clark, Tolin, Orsillo, 1999)

  14. Change in implementation of cognitive therapy skills [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    Skills of Cognitive Therapy (SoCT; Jarrett, 2010)

  15. Change in avoidance of internal experiences including thoughts, feelings, physical sensations. [ Time Frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame) ]
    The Multidimensional Experiential Avoidance Questionnaire (Gamez, Chmielewski, Kotov, Ruggero, & Watson, 2011)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143634


Locations
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United Kingdom
MRC Cognition and Brain Sciences Unit
Cambridge, United Kingdom, CB2 7EF
Sponsors and Collaborators
Medical Research Council Cognition and Brain Sciences Unit
Cambridgeshire and Peterborough NHS Foundation Trust
Investigators
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Principal Investigator: Tim Dalgleish, PhD Medical Research Council Cognition and Brain Sciences Unit

Publications:
First MB, Williams JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5—Research Version (SCID-5 for DSM-5, Research Version; SCID-5-RV). Arlington, VA, American Psychiatric Association, 2015
Kroenke, K.; Spitzer, R.L.The PHQ-9: A new depression diagnostic and severity measure. Psychiatric Annals, Vol 32(9), Sep 2002, 509-515. http://dx.doi.org/10.3928/0048-5713-20020901-06
IAPT/Department of Health, The IAPT data handbook version 2.0.1. 2011: Published to Department of Health Website, in electronic PDF format only
Foa, E.B., Kozak, M.J., Salkovskis, P.M., Coles, M.E., and Amir, N. (1998). The validation of a new obsessive-compulsive disorder scale: The Obsessive-Compulsive Inventory. Psychological Assessment, 10(3), 206-214.
Weiss, D.S., The Impact of Event Scale: Revised, in Cross-cultural assessment of psychological trauma and PTSD, J.P. Wilson and C.S. Tang, Editors. 2007, Springer: New York. p. 219-238.
Sheehan, D.V., The Anxiety Disease. 1983, New York: Charles Scribner and Sons.
Treynor, W., R. Gonzalez, and S. Nolen-Hoeksema, Rumination Reconsidered: A Psychometric Analysis. Cognitive Therapy and Research 2003. 27(3): p. 247-259.
Simons, J.S. and R.M. Gaher, The Distress Tolerance Scale: Development and Validation of a Self-Report Measure. Motivation and Emotion, 2005. 29(2): p. 83-102.
Gratz, K.L. & Roemer, L. Journal of Psychopathology and Behavioral Assessment (2004) 26: 41. doi:10.1023/B:JOBA.0000007455.08539.94
Weissman, A.N., The Dysfunctional Attitude Scale: A Validation Study. 1979, University of Pennsylvania.
Foa, E.B., Ehlers, A., Clark, D.M., Tolin, D.F., Orsillo, S.M., The Posttraumatic Cognitions Inventory (PTCI): Development and validation. Psychological Assessment, 1999. 11(3): p. 303-314.
Wechsler, D. (2008). Wechsler Adult Intelligence Scale—Fourth Edition. San Antonio, TX: Pearson.
Nelson HE, Wilson J (1991) National Adult Reading Test (NART), NFER-Nelson, Windsor, UK.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical Research Council Cognition and Brain Sciences Unit
ClinicalTrials.gov Identifier: NCT03143634     History of Changes
Other Study ID Numbers: MP:MH RfPB PB-PG-0214-33072
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Stress Disorders, Post-Traumatic
Panic Disorder
Phobia, Social
Agoraphobia
Pathologic Processes
Mental Disorders
Mood Disorders
Behavioral Symptoms
Personality Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Phobic Disorders