Major Depressive DisorderPhase 1/2MPMHNCT03143634

The Modular Protocol for Mental Health (MPMH)

A Phase 1/2 study testing The Modular Protocol for Mental Health and Treatment-as-usual in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder
What is being tested?: The Modular Protocol for Mental Health and Treatment-as-usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteUnited Kingdom
Study dates: 18 Jul 2017to 31 Jul 2020
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

MRC Cognition and Brain Sciences Unit
Cambridge, CB2 7EF

Other trials in United Kingdom

About this study

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

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.

Conditions: Major Depressive Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia
Being tested: The Modular Protocol for Mental Health, Treatment-as-usual
Medical subject headings: Depressive Disorder, Major, Generalized Anxiety Disorder, Stress Disorders, Post-Traumatic, Phobia, Social, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Modular Protocol for Mental HealthBehavioural
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-usualBehavioural
This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.

Study groups in NCT03143634
Study group	Role	What they receive
The Modular Protocol for Mental Health	Experimental	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 Receives: Behavioral: The Modular Protocol for Mental Health
Treatment-as-usual	Placebo comparator	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. Receives: Behavioral: Treatment-as-usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Depression symptoms
Patient Health Questionnaire - 9-item version (PHQ-9; Kroenke \& Spitzer, 2002)
Measured: 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)
Measured: 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)
Measured: Baseline (within two weeks of first treatment session), within one week of the final treatment session, three-months following final treatment session

Secondary outcomes (17)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 201731 Jul 2020

First posted8 May 2017
Study start18 Jul 2017
Primary completion31 Jul 2020
Study completion31 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (38)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03143634
Sponsor's protocol ID: MP:MH RfPB PB-PG-0214-33072
Acronym: MPMH
Status last verified: Sep 2020
First submitted: 27 Apr 2017
Last updated: 29 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

First MB, Williams JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5-Research Version (SCID-5 for DSM-5, Research Version; SCID-5-RV). Arlington, VA, American Psychiatric Association, 2015
Newby JM, McKinnon A, Kuyken W, Gilbody S, Dalgleish T. Systematic review and meta-analysis of transdiagnostic psychological treatments for anxiety and depressive disorders in adulthood. Clin Psychol Rev. 2015 Aug;40:91-110. doi: 10.1016/j.cpr.2015.06.002. Epub 2015 Jun 6.
PubMed 26094079
Kroenke, K.; Spitzer, R.L.The PHQ-9: A new depression diagnostic and severity measure. Psychiatric Annals, Vol 32(9), Sep 2002, 509-515. http://dx.doi.org/10.3928/0048-5713-20020901-06
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645
IAPT/Department of Health, The IAPT data handbook version 2.0.1. 2011: Published to Department of Health Website, in electronic PDF format only
Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
PubMed 10827888
Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
PubMed 2076086
Foa, E.B., Kozak, M.J., Salkovskis, P.M., Coles, M.E., and Amir, N. (1998). The validation of a new obsessive-compulsive disorder scale: The Obsessive-Compulsive Inventory. Psychological Assessment, 10(3), 206-214.
Weiss, D.S., The Impact of Event Scale: Revised, in Cross-cultural assessment of psychological trauma and PTSD, J.P. Wilson and C.S. Tang, Editors. 2007, Springer: New York. p. 219-238.
Chambless DL, Caputo GC, Jasin SE, Gracely EJ, Williams C. The Mobility Inventory for Agoraphobia. Behav Res Ther. 1985;23(1):35-44. doi: 10.1016/0005-7967(85)90140-8. No abstract available.
PubMed 3985915
Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.
PubMed 526242
Shear MK, Brown TA, Barlow DH, Money R, Sholomskas DE, Woods SW, Gorman JM, Papp LA. Multicenter collaborative panic disorder severity scale. Am J Psychiatry. 1997 Nov;154(11):1571-5. doi: 10.1176/ajp.154.11.1571.
PubMed 9356566
Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002 Jul;32(5):843-53. doi: 10.1017/s0033291702005822.
PubMed 12171378
Sheehan, D.V., The Anxiety Disease. 1983, New York: Charles Scribner and Sons.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03143634
Acronym / sponsor ID: MPMH / MP:MH RfPB PB-PG-0214-33072
Conditions: Major Depressive Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Medical Research Council Cognition and Brain Sciences UnitOther government
Collaborators: Cambridgeshire and Peterborough NHS Foundation Trust
Study start: 18 Jul 2017 (actual)
Primary completion: 31 Jul 2020 (actual)
Study completion: 31 Jul 2020 (actual)
First posted: 8 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The Modular Protocol for Mental Health	Experimental	Behavioral: The Modular Protocol for Mental HealthThe 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
Treatment-as-usual	Placebo comparator	Behavioral: Treatment-as-usualFor 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Modular Protocol for Mental HealthThis 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.	Behavioural	The Modular Protocol for Mental Health
Treatment-as-usualThis intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.	Behavioural	Treatment-as-usual

Primary outcome

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)
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)
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)

17 secondary outcomes

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
BackgroundFirst MB, Williams JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5-Research Version (SCID-5 for DSM-5, Research Version; SCID-5-RV). Arlington, VA, American Psychiatric Association, 2015
Background: PubMed 26094079Newby JM, McKinnon A, Kuyken W, Gilbody S, Dalgleish T. Systematic review and meta-analysis of transdiagnostic psychological treatments for anxiety and depressive disorders in adulthood. Clin Psychol Rev. 2015 Aug;40:91-110. doi: 10.1016/j.cpr.2015.06.002. Epub 2015 Jun 6.
BackgroundKroenke, K.; Spitzer, R.L.The PHQ-9: A new depression diagnostic and severity measure. Psychiatric Annals, Vol 32(9), Sep 2002, 509-515. http://dx.doi.org/10.3928/0048-5713-20020901-06
Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
BackgroundIAPT/Department of Health, The IAPT data handbook version 2.0.1. 2011: Published to Department of Health Website, in electronic PDF format only
Background: PubMed 10827888Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
Background: PubMed 2076086Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
BackgroundFoa, E.B., Kozak, M.J., Salkovskis, P.M., Coles, M.E., and Amir, N. (1998). The validation of a new obsessive-compulsive disorder scale: The Obsessive-Compulsive Inventory. Psychological Assessment, 10(3), 206-214.
BackgroundWeiss, D.S., The Impact of Event Scale: Revised, in Cross-cultural assessment of psychological trauma and PTSD, J.P. Wilson and C.S. Tang, Editors. 2007, Springer: New York. p. 219-238.
Background: PubMed 3985915Chambless DL, Caputo GC, Jasin SE, Gracely EJ, Williams C. The Mobility Inventory for Agoraphobia. Behav Res Ther. 1985;23(1):35-44. doi: 10.1016/0005-7967(85)90140-8. No abstract available.
Background: PubMed 526242Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tim Dalgleish, PhD principal investigator

Medical Research Council Cognition and Brain Sciences Unit

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03143634, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.