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Completed

NCT Number: NCT03143634

The Modular Protocol for Mental Health (MPMH)

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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Key information

Conditions

Major Depressive Disorder Agoraphobia Anxiety Disorders Depressive Disorder Depressive Disorder, Major Generalized Anxiety Disorder Illness Anxiety Disorder Mental Disorders Mood Disorders Obsessive-Compulsive Disorder Panic Disorder Phobia, Social Phobic Disorders Posttraumatic Stress Disorder Social Anxiety Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

MRC Cognition and Brain Sciences Unit

Cambridge, CB2 7EF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Treatment-as-usual

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medical Research Council Cognition and Brain Sciences Unit

Other Gov

Collaborators

  • Cambridgeshire and Peterborough NHS Foundation Trust

Registry information

Official study 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

Acronym: MPMH

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 8, 2017
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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