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Primary Care Trial Efficacy of Alternative Modalities (PCTEAM)

Primary Care Trial Efficacy of Alternative Modalities (PCTEAM): a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27529354
Enrollment
150
Registered
2014-08-08
Start date
2014-07-01
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Mental Health, Primary Care

Interventions

Low-intensity interventions: The Low-intensity interventions delivered within the service are based on principles of CBT. The interventions offered include aspects, such as psycho-education and cogni
for example, behavioural activation, cognitive restructuring, sleep management and problem solving. Take Control Course (TCC), The TCC is a group treatment. It consists of six weekly s
Study Entry : Single Randomisation only

Sponsors

University of Manchester (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 16 and above 2. Suitability for low-intensity services. This includes individuals with mild-moderate depression and anxiety that has emerged within the12 months prior to referral (i.e. the problem is not a chronic and enduring one). However, other mild to moderate problems can be addressed within this service context and clinical decision-making is according to stepped care models, i.e. other factors that are considered are level of suicidality (see exclusion criteria) and the extent to which problems impair functioning 3. Sufficient English language skills to understand material (i.e. verbal and written language abilities required to read and complete simple worksheets and understand verbal presentations)

Exclusion criteria

Exclusion criteria: 1. Clients under 16 2. Suitability for higher intensity services that is primarily determined after first assessment with the service; for example, clients with Post Traumatic Stress Disorder or severe Obsessive Compulsive Disorder; clients with persistent self-injury requiring clinical management or who were potentially intent on and/or planning suicide; clients who are currently experiencing psychotic symptoms; have current substance dependence; or have an organic brain impairment, such as dementia 3. Literacy or language difficulties that will preclude them from reading simple worksheets or from conversing with a healthcare professional

Design outcomes

Primary

MeasureTime frame
1. Patient Health Questionnaire Depression Scale (PHQ9); Timepoint(s): Baseline, 6 months and 12 months post baseline 2. Generalised Anxiety Disorder Questionnaire (GAD7); Timepoint(s): Baseline, 6 months and 12 months post baseline

Secondary

MeasureTime frame
1. Adult Service Use Schedule (AD-SUS); Timepoint(s): Baseline, 6 months and 12 months post baseline 2. EQ5D; Timepoint(s): Baseline, 6 months and 12 months post baseline 3. PSYCHLOPS; Timepoint(s): Baseline, 6 months and 12 months post baseline 4. Work and Social Adjustment Scale (WSAS); Timepoint(s): Baseline, 6 months and 12 months post baseline

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026