Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2017-07-18
2020-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
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.
Treatment-as-usual
This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.
Interventions
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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.
Eligibility Criteria
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Inclusion 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Cambridgeshire and Peterborough NHS Foundation Trust
OTHER
Medical Research Council Cognition and Brain Sciences Unit
OTHER_GOV
Responsible Party
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Principal Investigators
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Tim Dalgleish, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical Research Council Cognition and Brain Sciences Unit
Locations
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MRC Cognition and Brain Sciences Unit
Cambridge, , United Kingdom
Countries
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References
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Other Identifiers
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MP:MH RfPB PB-PG-0214-33072
Identifier Type: -
Identifier Source: org_study_id
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