The Modular Protocol for Mental Health (MPMH)

Major Depressive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143634
• Other study ID #: MP:MH RfPB PB-PG-0214-33072
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 18, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2020
• Source: Medical Research Council Cognition and Brain Sciences Unit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Illness Anxiety Disorder
• Major Depressive Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder
• Phobia, Social
• Posttraumatic Stress Disorder
• Social Anxiety Disorder
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
United Kingdom	MRC Cognition and Brain Sciences Unit	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council Cognition and Brain Sciences Unit	Cambridgeshire and Peterborough NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (37)

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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.

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Gámez 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. — View Citation

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Gratz, K.L. & Roemer, L. Journal of Psychopathology and Behavioral Assessment (2004) 26: 41. doi:10.1023/B:JOBA.0000007455.08539.94

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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

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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. — View Citation

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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