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

The Modular Protocol for Mental Health (MPMH): A Pilot Randomised Clinical Trial of a Transdiagnostic Psychological Treatment for Mood and Anxiety Disorders in Adults

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Major Depressive Disorder; Posttraumatic Stress Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia; Illness Anxiety Disorder
• Intervention / Treatment: Behavioral: The Modular Protocol for Mental Health; Behavioral: Treatment-as-usual

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 7EF
    • MRC Cognition and Brain Sciences Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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	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.	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	The Revised Impact of Event Scale (IES-R; Weiss, 2007). This measure will only be completed by participants with symptoms of PTSD.	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 agoraphobia	The Agoraphobia-Mobility Inventory (MI; Chambless, Caputo, Jasin, Gracely, & Williams, 1985). This measure will only be completed by participants with symptoms of agoraphobia.	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 specific phobias	The Fear Questionnaire (FQ; Marks & Mathews, 1979). This measure will only be completed by participants with symptoms of 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 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.	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 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.	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	Sheehan Disability Scale (SDS; Sheehan, 1983)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in expectancy about treatment outcome, as well as the credibility of the treatment	The Treatment Credibility / Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in ability to contextualize negative events within a wider frame of reference	Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2000)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in disengagement from and acceptance of troublesome mental content, rumination	Experiences Questionnaire (EQ; Fresco et al., 2007)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Intensity with which participants experience 36 different emotions on a typical day	Differential Emotions Scale (DES; Izard, 1993)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy	Levels of Personality Functioning Scale (LPFS; Morey et al., 2017)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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)	Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in measure of memory specificity	Autobiographical Memory Test (Williams & Broadbent, 1986).	Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in cognitive flexibility for emotional information	Affective Card Sorting Task (Barcelo, 2003; Deveney & Deldin, 2006)	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	Digit Span Task (Wechsler, 2008)	Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in brief measure of premorbid intelligence	National Adult Reading Test (Nelson & Wilson, 1991)	Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in emotional structure (awareness and differentiation)	Levels of Emotional Awareness Scale (Lane et al., 1990)	Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in potential neurobiomarkers that may account for risk of disorders and/or predict treatment response (optional component of participation)	Functional connectivity during resting state MRI	Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in levels of rumination	Ruminative Responses Scale of the Response Styles Questionnaire (RRS; Treynor, Gonzalez, Nolen-Hoeksema, 2003)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in ability to tolerate distress	Distress Tolerance Scale (DTS; Simons & Gaher, 2005)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in ability to label, perceive, and regulate emotions	Difficulties with Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in negative beliefs, thoughts and assumptions	Dysfunctional Attitudes Scale (DAS; Weissman, 1979)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in mindful awareness	Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in fear of physical anxiety sensations	Anxiety Sensitivity Index (ASI; Reiss, Peterson, Gursky, & McNally 1986)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in trauma-related beliefs and maladaptive appraisals of intrusive symptoms	Posttraumatic cognitions inventory - short version (PTCI; Foa, Ehlers, Clark, Tolin, Orsillo, 1999)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in implementation of cognitive therapy skills	Skills of Cognitive Therapy (SoCT; Jarrett, 2010)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in avoidance of internal experiences including thoughts, feelings, physical sensations.	The Multidimensional Experiential Avoidance Questionnaire (Gamez, Chmielewski, Kotov, Ruggero, & Watson, 2011)	Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

Collaborators and Investigators

• Sponsor: Medical Research Council Cognition and Brain Sciences Unit
• Collaborators: Cambridgeshire and Peterborough NHS Foundation Trust
• Investigators: Principal Investigator: Tim Dalgleish, PhD, Medical Research Council Cognition and Brain Sciences Unit

Publications and helpful links

General Publications

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
• Reiss S, Peterson RA, Gursky DM, McNally RJ. Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther. 1986;24(1):1-8. doi: 10.1016/0005-7967(86)90143-9. No abstract available.
• Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: the Kentucky inventory of mindfulness skills. Assessment. 2004 Sep;11(3):191-206. doi: 10.1177/1073191104268029.
• Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
• Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
• Gamez W, Chmielewski M, Kotov R, Ruggero C, Watson D. Development of a measure of experiential avoidance: the Multidimensional Experiential Avoidance Questionnaire. Psychol Assess. 2011 Sep;23(3):692-713. doi: 10.1037/a0023242.
• Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002 Jul;32(5):843-53. doi: 10.1017/s0033291702005822.
• Shear MK, Brown TA, Barlow DH, Money R, Sholomskas DE, Woods SW, Gorman JM, Papp LA. Multicenter collaborative panic disorder severity scale. Am J Psychiatry. 1997 Nov;154(11):1571-5. doi: 10.1176/ajp.154.11.1571.
• Chambless DL, Caputo GC, Jasin SE, Gracely EJ, Williams C. The Mobility Inventory for Agoraphobia. Behav Res Ther. 1985;23(1):35-44. doi: 10.1016/0005-7967(85)90140-8. No abstract available.
• Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.
• Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.
• Wechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson.
• 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
• Newby JM, McKinnon A, Kuyken W, Gilbody S, Dalgleish T. Systematic review and meta-analysis of transdiagnostic psychological treatments for anxiety and depressive disorders in adulthood. Clin Psychol Rev. 2015 Aug;40:91-110. doi: 10.1016/j.cpr.2015.06.002. Epub 2015 Jun 6.
• 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.
• Garnefski N, Rieffe C, Jellesma F, Terwogt MM, Kraaij V. Cognitive emotion regulation strategies and emotional problems in 9 - 11-year-old children: the development of an instrument. Eur Child Adolesc Psychiatry. 2007 Feb;16(1):1-9. doi: 10.1007/s00787-006-0562-3. Epub 2006 Jun 21.
• Izard CE, Libero DZ, Putnam P, Haynes OM. Stability of emotion experiences and their relations to traits of personality. J Pers Soc Psychol. 1993 May;64(5):847-60. doi: 10.1037//0022-3514.64.5.847.
• Morey LC. Development and initial evaluation of a self-report form of the DSM-5 Level of Personality Functioning Scale. Psychol Assess. 2017 Oct;29(10):1302-1308. doi: 10.1037/pas0000450. Epub 2017 Feb 27.
• Salisbury C, O'Cathain A, Edwards L, Thomas C, Gaunt D, Hollinghurst S, Nicholl J, Large S, Yardley L, Lewis G, Foster A, Garner K, Horspool K, Man MS, Rogers A, Pope C, Dixon P, Montgomery AA. Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention. Lancet Psychiatry. 2016 Jun;3(6):515-25. doi: 10.1016/S2215-0366(16)00083-3. Epub 2016 Apr 27.
• 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.
• Jarrett RB, Vittengl JR, Clark LA, Thase ME. Skills of Cognitive Therapy (SoCT): a new measure of patients' comprehension and use. Psychol Assess. 2011 Sep;23(3):578-86. doi: 10.1037/a0022485.
• Williams JM, Broadbent K. Autobiographical memory in suicide attempters. J Abnorm Psychol. 1986 May;95(2):144-9. doi: 10.1037//0021-843x.95.2.144. No abstract available.
• Deveney CM, Deldin PJ. A preliminary investigation of cognitive flexibility for emotional information in major depressive disorder and non-psychiatric controls. Emotion. 2006 Aug;6(3):429-437. doi: 10.1037/1528-3542.6.3.429.
• Barcelo F. The Madrid card sorting test (MCST): a task switching paradigm to study executive attention with event-related potentials. Brain Res Brain Res Protoc. 2003 Mar;11(1):27-37. doi: 10.1016/s1385-299x(03)00013-8.
• Nelson HE, Wilson J (1991) National Adult Reading Test (NART), NFER-Nelson, Windsor, UK.
• Lane RD, Quinlan DM, Schwartz GE, Walker PA, Zeitlin SB. The Levels of Emotional Awareness Scale: a cognitive-developmental measure of emotion. J Pers Assess. 1990 Fall;55(1-2):124-34. doi: 10.1080/00223891.1990.9674052.
• Black M, Hitchcock C, Bevan A, O Leary C, Clarke J, Elliott R, Watson P, LaFortune L, Rae S, Gilbody S, Kuyken W, Johnston D, Newby JM, Dalgleish T. The HARMONIC trial: study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds-a modular transdiagnostic intervention for mood, stressor-related and anxiety disorders in adults. BMJ Open. 2018 Aug 5;8(8):e024546. doi: 10.1136/bmjopen-2018-024546.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Trauma and Stressor Related Disorders; Phobic Disorders; Stress Disorders, Traumatic; Depressive Disorder; Disease; Obsessive-Compulsive Disorder; Anxiety Disorders; Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Phobia, Social; Panic Disorder; Agoraphobia
• Other Study ID Numbers: MP:MH RfPB PB-PG-0214-33072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No