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| Name | Class |
|---|---|
| Cambridgeshire and Peterborough NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Dalgleish, PhD | Medical Research Council Cognition and Brain Sciences Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRC Cognition and Brain Sciences Unit | Cambridge | CB2 7EF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 26094079 | Background | 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. | |
| Background | 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 | ||
| 16717171 |
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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.
|
| Treatment-as-usual | Behavioral | This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists. |
|
| 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 |
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) |
| Background |
| 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. |
| 11983645 | Background | 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. |
| Background | IAPT/Department of Health, The IAPT data handbook version 2.0.1. 2011: Published to Department of Health Website, in electronic PDF format only |
| 10827888 | Background | 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. |
| 2076086 | Background | 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. |
| Background | 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. |
| Background | 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. |
| 3985915 | Background | 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. |
| 526242 | Background | 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. |
| 9356566 | Background | 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. |
| 12171378 | Background | 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. |
| Background | Sheehan, D.V., The Anxiety Disease. 1983, New York: Charles Scribner and Sons. |
| 11132119 | Background | 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. |
| 16791542 | Background | 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. |
| 17697849 | Background | 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. |
| 8505713 | Background | 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. |
| 28240933 | Background | 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. |
| 9626712 | Background | 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. |
| 27132075 | Background | 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. |
| Background | Treynor, W., R. Gonzalez, and S. Nolen-Hoeksema, Rumination Reconsidered: A Psychometric Analysis. Cognitive Therapy and Research 2003. 27(3): p. 247-259. |
| Background | 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. |
| Background | Gratz, K.L. & Roemer, L. Journal of Psychopathology and Behavioral Assessment (2004) 26: 41. doi:10.1023/B:JOBA.0000007455.08539.94 |
| Background | Weissman, A.N., The Dysfunctional Attitude Scale: A Validation Study. 1979, University of Pennsylvania. |
| 15358875 | Background | 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. |
| 3947307 | Background | 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. |
| Background | 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. |
| 21319902 | Background | 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. |
| 21534697 | Background | 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. |
| 3711438 | Background | 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. |
| 16938084 | Background | 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. |
| 12697260 | Background | 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. |
| Background | Wechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson. |
| Background | Nelson HE, Wilson J (1991) National Adult Reading Test (NART), NFER-Nelson, Windsor, UK. |
| 2231235 | Background | 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. |
| 30082367 | Derived | 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. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D000098647 | Generalized Anxiety Disorder |
| D013313 | Stress Disorders, Post-Traumatic |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| D000379 | Agoraphobia |
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D008603 | Mental Health |
| ID | Term |
|---|---|
| D006262 | Health |
| D011154 | Population Characteristics |
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