A Phase 1/2 interventional study of The Modular Protocol for Mental Health and Treatment-as-usual in Major Depressive Disorder, Generalized Anxiety Disorder and Posttraumatic Stress Disorder, sponsored by Medical Research Council Cognition and Brain Sciences Unit. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-29.
Sponsored by Medical Research Council Cognition and Brain Sciences Unit · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
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
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 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.
Change in Depression symptoms
Patient Health Questionnaire - 9-item version (PHQ-9; Kroenke \& Spitzer, 2002)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in Anxiety symptoms
General Anxiety Disorder Questionnaire - 7-item version (GAD-7; Spitzer, Kroenke, Williams, \& Lowe, 2006)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in Level of disability and functional impairment
Work and Social Adjustment Scale (WSAS; Mundt, J.C. et al., 2002)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
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.
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in level of disability and functional impairment
Sheehan Disability Scale (SDS; Sheehan, 1983)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in expectancy about treatment outcome, as well as the credibility of the treatment
The Treatment Credibility / Expectancy Questionnaire (CEQ; Devilly \& Borkovec, 2000)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in ability to contextualize negative events within a wider frame of reference
Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij \& Spinhoven, 2000)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in disengagement from and acceptance of troublesome mental content, rumination
Experiences Questionnaire (EQ; Fresco et al., 2007)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Intensity with which participants experience 36 different emotions on a typical day
Differential Emotions Scale (DES; Izard, 1993)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in personality functioning on four subscales: Identity, Self-Direction, Empathy, and Intimacy
Levels of Personality Functioning Scale (LPFS; Morey et al., 2017)
Time frame: 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)
Time frame: 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
World Health Organisation (WHO) Quality of Life Inventory (WHOQOL; World Health Organisation, 1998)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session
Change in measure of memory specificity
Autobiographical Memory Test (Williams \& Broadbent, 1986).
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in cognitive flexibility for emotional information
Affective Card Sorting Task (Barcelo, 2003; Deveney \& Deldin, 2006)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in immediate recall and working memory for neutral information
Digit Span Task (Wechsler, 2008)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in brief measure of premorbid intelligence
National Adult Reading Test (Nelson \& Wilson, 1991)
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in emotional structure (awareness and differentiation)
Levels of Emotional Awareness Scale (Lane et al., 1990)
Time frame: 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)
Functional connectivity during resting state MRI
Time frame: Baseline (within two weeks of first treatment session), within one week of the final treatment session
Change in levels of rumination
Ruminative Responses Scale of the Response Styles Questionnaire (RRS; Treynor, Gonzalez, Nolen-Hoeksema, 2003)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in ability to tolerate distress
Distress Tolerance Scale (DTS; Simons \& Gaher, 2005)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in ability to label, perceive, and regulate emotions
Difficulties with Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in negative beliefs, thoughts and assumptions
Dysfunctional Attitudes Scale (DAS; Weissman, 1979)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in mindful awareness
Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, \& Allen, 2004)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in fear of physical anxiety sensations
Anxiety Sensitivity Index (ASI; Reiss, Peterson, Gursky, \& McNally 1986)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in trauma-related beliefs and maladaptive appraisals of intrusive symptoms
Posttraumatic cognitions inventory - short version (PTCI; Foa, Ehlers, Clark, Tolin, Orsillo, 1999)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in implementation of cognitive therapy skills
Skills of Cognitive Therapy (SoCT; Jarrett, 2010)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
Change in avoidance of internal experiences including thoughts, feelings, physical sensations.
The Multidimensional Experiential Avoidance Questionnaire (Gamez, Chmielewski, Kotov, Ruggero, \& Watson, 2011)
Time frame: Within one-week pre-delivery of relevant treatment module; within one-week post-delivery of relevant treatment module (varied time-frame)
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Medical Research Council Cognition and Brain Sciences Unit