Effectiveness of the internet-based Unified Protocol mental health intervention for depression, anxiety, and related difficulties

Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety, and related disorders in a primary care setting: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18056450

Enrollment

120

Registered

2021-09-13

Start date

2021-10-08

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Depression, anxiety, and related disorders in a primary care setting Mental and Behavioural Disorders Depressive episode, Anxiety disorder, unspecified

Interventions

The current study will employ a parallel-groups, randomised controlled trial design. Participants will be randomly assigned to a) the internet-based Unified Protocol (iUP), or b) enhanced waiting list

eWLC=40). Assessments will take place at baseline, 4 weeks, 8 weeks and 12 weeks from baseline. For ethical reasons the eWLC group participants will be offered iUP treatment after 12 weeks. iUP group

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Minimum age 18 years old 2. Fluent in English 3. Have access to the Internet and an email account 4. Have symptoms of anxiety and/or depression referenced as primary presenting problem(s) on the referral form from the General Practitioner (GP) 5. A score of =8 on OASIS (Norma et al., 2006; Campbell-Sills et al., 2009) and/or a score of =8 on ODSIS (Bentley et al., 2014)

Exclusion criteria

Exclusion criteria: 1. An increased risk of suicidality intent or ideation (at least moderate scores on the M.I.N.I. [see below about MINI] and/or a score > 2 on item 9 from the PHQ-9 [see below about PHQ-9]), 2. Psychotic disorder, manic or hypomanic episode, bipolar disorder, eating disorder, anti-social personality disorder and/or alcohol/substance use disorder as indicated by the M.I.N.I. 3. References to cognitive impairment on the referral form 4. Receipt of another psychological treatment at the start of the study Pharmacological treatment during the treatment period will be allowed provided that it was stabilized 6 weeks prior to the start of being involved in the study.

Design outcomes

Primary

Measure	Time frame
1. Anxiety measured using the Overall Anxiety Severity And Impairment Scale (OASIS) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 2. Depression measured using the Overall Depression Severity and Impairment Scale ODSIS (ODSIS) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group	—

Secondary

Measure	Time frame
1. Social Adjustment measured using the Work and Social Adjustment Scale (WSAS) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 2. Anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group and also used as a specific measure for clients with a primary diagnosis of generalized anxiety 3. Depression measured using the Patient Health Questionnaire-9 (PHQ-9) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group and also used as a specific measure for clients with a primary diagnosis of depression 4. One of the following measures (depending on the primary diagnosis): 4.1. Only for clients with primary diagnosis of panic disorder, panic disorder symptoms measured using the Panic Disorder Severity Scale-Self Report (PDSS-SR) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 4.2. Only for clients with primary diagnosis of social anxiety, social Anxiety symptoms measured using the Social Phobia Inventory (SPIN) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 4.3. Only for clients with primary diagnosis of OCD, OCD symptoms measured using the Obsessive-compulsive Inventory-Revised (OCI-R) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 4.4. Only for clients with primary diagnosis of PTSD, PTSD symptoms measured using the PCL-5 at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 5. Client experiences of helpful/unhelpful aspects of the iUP intervention and experiences of changes attributable to the intervention measured using a questionnaire version of the Client Change Interview Protocol (CCIP) at week 12 only the iUP group	—

Measure

Time frame

1. Social Adjustment measured using the Work and Social Adjustment Scale (WSAS) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 2. Anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group and also used as a specific measure for clients with a primary diagnosis of generalized anxiety 3. Depression measured using the Patient Health Questionnaire-9 (PHQ-9) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group and also used as a specific measure for clients with a primary diagnosis of depression 4. One of the following measures (depending on the primary diagnosis): 4.1. Only for clients with primary diagnosis of panic disorder, panic disorder symptoms measured using the Panic Disorder Severity Scale-Self Report (PDSS-SR) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 4.2. Only for clients with primary diagnosis of social anxiety, social Anxiety symptoms measured using the Social Phobia Inventory (SPIN) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 4.3. Only for clients with primary diagnosis of OCD, OCD symptoms measured using the Obsessive-compulsive Inventory-Revised (OCI-R) at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 4.4. Only for clients with primary diagnosis of PTSD, PTSD symptoms measured using the PCL-5 at 0, 4, 8, 12, 16, 20, 24 weeks for the iUP group and 0, 4, 8, 12 for the eWL group 5. Client experiences of helpful/unhelpful aspects of the iUP intervention and experiences of changes attributable to the intervention measured using a questionnaire version of the Client Change Interview Protocol (CCIP) at week 12 only the iUP group

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Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026