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.

Major Depressive Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Illness Anxiety Disorder

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.

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

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.

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.

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

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)

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

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.

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.

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.

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.

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.

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.

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.

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.

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.

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

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

Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session

Baseline (within two weeks of first treatment session), within one week of the final treatment session

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)

Baseline (within two weeks of first treatment session), within one week of the final treatment session

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)

Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied 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)

Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)

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.

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