The Modular Protocol for Mental Health (MPMH)

Sponsor

Medical Research Council Cognition and Brain Sciences Unit (Other)

Overall Status

Completed

CT.gov ID

NCT03143634

Collaborator

Cambridgeshire and Peterborough NHS Foundation Trust (Other)

Enrollment

Location

Arms

36.4

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

43 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 :

Jul 18, 2017

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Depression symptoms [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)
Change in Anxiety symptoms [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)
Change in Level of disability and functional impairment [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

Change in symptoms of social phobia, agoraphobia and specific phobia [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.
Change in 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]
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.
Change in symptoms of generalised anxiety [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.
Change in 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]
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.
Change in symptoms of post-traumatic stress disorder [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.
Change in 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]
The Agoraphobia-Mobility Inventory (MI; Chambless, Caputo, Jasin, Gracely, & Williams, 1985). This measure will only be completed by participants with symptoms of agoraphobia.
Change in symptoms of specific phobias [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.
Change in 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]
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.
Change in 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]
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.
Change in level of disability and functional impairment [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)
Change in expectancy about treatment outcome, as well as the credibility of the treatment [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)
Change in ability to contextualize negative events within a wider frame of reference [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)
Change in disengagement from and acceptance of troublesome mental content, rumination [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)
Intensity with which participants experience 36 different emotions on a typical day [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)
Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy [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)
Change in use of NHS services, other mental health services or activities, help at home, and time off work/lost income [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)
Change in quality of life assessment of health and wellbeing, daily functioning, and general life satisfaction across multiple domains [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

Change in measure of memory specificity [Baseline (within two weeks of first treatment session), within one week of the final treatment session]
Autobiographical Memory Test (Williams & Broadbent, 1986).
Change in cognitive flexibility for emotional information [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)
Change in immediate recall and working memory for neutral information [Baseline (within two weeks of first treatment session), within one week of the final treatment session]
Digit Span Task (Wechsler, 2008)
Change in brief measure of premorbid intelligence [Baseline (within two weeks of first treatment session), within one week of the final treatment session]
National Adult Reading Test (Nelson & Wilson, 1991)
Change in emotional structure (awareness and differentiation) [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)
Change in potential neurobiomarkers that may account for risk of disorders and/or predict treatment response (optional component of participation) [Baseline (within two weeks of first treatment session), within one week of the final treatment session]
Functional connectivity during resting state MRI
Change in levels of rumination [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)
Change in ability to tolerate distress [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)
Change in ability to label, perceive, and regulate emotions [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)
Change in negative beliefs, thoughts and assumptions [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)
Change in mindful awareness [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)
Change in fear of physical anxiety sensations [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)
Change in trauma-related beliefs and maladaptive appraisals of intrusive symptoms [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)
Change in implementation of cognitive therapy skills [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)
Change in avoidance of internal experiences including thoughts, feelings, physical sensations. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.