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TherapyMatch-D: A randomized controlled trial of psychological treatment selection for depression

A pilot cluster randomized controlled trial of psychological treatment selection for depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21721966
Enrollment
376
Registered
2023-08-22
Start date
2023-09-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Depression Mental and Behavioural Disorders

Interventions

Talking Therapy sites will be randomised to the TherapyMatch-D group (experimental) or allocation as usual (control). During the initial assessment, clinicians in both groups will input pseudo-anonymi
PCE-CfD) will be provided with a treatment recommendation and then use shared decision making to reach a final decision. In the allocation as usual group, patients will not be given a recommendation

Sponsors

Rotherham Doncaster and South Humber NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Therapists/Counsellors: 1. Be employed by a participating IAPT service on a permanent contract, or be employed as temporary staff with a contract that is at least as long as the expected timescale for the project (1 year) 2. Hold a UK-recognized qualification and be approved by IAPT to carry out routine assessments in an IAPT service 3. Attended a group/individual training on how to utilize the computer programme TherapyMatch-D Patients 1. Adults (18 years of age or older). 2. With depression (defined as scoring at least 10 on the PHQ-9), including those with co-morbid anxiety and those taking antidepressant medication (we will monitor and examine potential confounding effects of comorbidity and medication). 3. Seeking mental health care in IAPT services at Step 3 (normally via self-referral, GP referral or stepped up from Step 2 low-intensity IAPT treatment). 4. Deemed eligible for high-intensity treatment in IAPT by assessing therapists (often patients who do not improve at the earlier steps of care), regardless of any prior mental health treatment from IAPT or elsewhere (we will monitor and examine potential confounding effects of prior treatment and baseline severity). 5. Able to take part in the initial assessment in English without the need for interpreters or substantial communication adaptations. Note. The researchers will gather information from all consenting participants (216 per arm). However, only those will a differential treatment response as identified by the algorithm in the TherapyMatch-D computer programme, which we estimate would be approximately 30% of the 216 participants (64 participants per arm), will be included in the primary outcome analysis. In the sub-study, purposive sampling will be used to recruit 4 patients from each arm of the trial (2 per intervention) and 4 clinicians from each arm of the trial. This will result in a planned sample size of 16 participants.

Exclusion criteria

Exclusion criteria: Therapists/Counsellors: 1. Employment contract with IAPT service is shorter than the expected timescale for the study (1 year) 2. Currently in training (since they are not yet fully qualified to carry out routine assessments) without holding a UK-recognized qualification 3. Failure to attend a group/individual training on how to utilize the digital tool TherapyMatch-D Patients: 1. Individuals below 18 years old 2. Lack of ability to provide informed consent to participate (as determined by the assessing therapist as part of a routine assessment) 3. Patients who do not provide informed consent to participate 4. Patients who are assessed as ineligible for treatment in IAPT (e.g., those who are signposted to other services, or lacking capacity to consent to an assessment). Specific criteria for IAPT exclusion are detailed elsewhere. Common examples include having other severe mental health disorders, highly acute suicide risk, and comorbid substance use disorder that interferes with the person’s ability to engage in therapy 5. Unable to take part in the initial assessment due to language or communication barriers, or requiring substantial adaptations or interpreters

Design outcomes

Primary

MeasureTime frame
Reliable and Clinically Significant Improvement (RCSI) in depression, measured by the Patient Health Questionnaire-9 questionnaire (PHQ-9) at the end of the treatment period (last session of therapy, either CBT or PCE-CfD)

Secondary

MeasureTime frame
1. Adherence to treatment selection recommendation measured using a question embedded in the TherapyMatch-D computer programme ("does the treatment selected match the recommended treatment by the TherapyMatch-D app?") during initial assessment with client 2. Outcome expectancy (OE) measured using a question embedded in the TherapyMatch-D computer programme (“At this point in time, how confident are you that this kind of treatment will work for you on a scale of 0 (not at all) to 10 (definitely)?”) during initial assessment with client 3. Anxiety measured using the Generalized Anxiety Disorder (GAD-7) at initial assessment, and at each therapy session throughout treatment 4. Functional impairment measured using the Work and Social Adjustment Scale (WSAS) questionnaire at initial assessment, and at each therapy session throughout treatment 5. Clinical, demographic and service utilisation data (such as age, employment status, self-reported disability, index of multiple deprivation, ethnicity, chronicity, antidepressant medication, diagnoses, number of therapy sessions, reason for discharge) measured using the TherapyMatch-D computer programme questionnaire and routine data collected by Talking Therapy sites. Data will be collected at initial assessment, and throughout routine treatment provided 6. Personality profile measured using the Standardized Assessment of Personality–Abbreviated Scale (SAPAS) at initial assessment 7. Adverse events measured using compare rates of reliable deterioration in patients across both arms of the trial at the end of the trial

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026