Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in IAPT

Study Overview
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Brief Summary
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Depression and anxiety are common mental health problems. There are effective treatments for depression and anxiety and one of these is talking therapies using cognitive behaviour therapy (CBT). In recent years CBT has been transferred to online delivery methods and these interventions have proven successful for people being treated with symptoms of depression and anxiety. The current study will utilise a randomised controlled trial design, where the majority (n=240) of participants will be allocated to the immediate treatment (internet-delivered CBT for either depression or anxiety), and a smaller number (n=120) will be allocated to a waiting list. The waiting list group will receive treatment after an eight week wait. This design helps us to understand that any changes in symptoms in the treatment group will be likely due to the treatment they received compared to the waiting list. A sample size of 360 participants is proposed and has been adjusted to ameliorate against patient dropout. Follow-up and maintenance of any positive changes in symptoms is very important in CBT for depression and anxiety, simply because some people can have a relapse of symptoms. We will therefore follow-up the treatment group for 3, 6, 9 and 12 months to assess maintenance of positive gains from treatment. The study also seeks to investigate the cost effectiveness of the treatments.

Detailed Description
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A CONSORT compliant single-blinded, parallel-groups, randomised controlled trial design will be used to examine the efficacy of internet-delivered interventions for depression and anxiety disorders against a waiting list control group. To be eligible participants will be screened and will need to score ≥ 9 on the PHQ-9 and / or ≥ 8 on the GAD-7. To establish a formal diagnosis of depression or anxiety, eligible participants will complete the M.I.N.I. neuropsychiatric interview and thereafter will be randomised to either an immediate treatment group or a waiting list group. Randomisation will follow a 2:1 ratio. The immediate treatment will complete a M.I.N.I. neuropsychiatric interview at 3-months follow-up from baseline. The treatment group will be followed up at 6-, 9- and 12-months post-treatment. The waiting list control group will be enrolled into the treatment once the immediate treatment group will have completed. The waiting list will complete baseline screening and research measures at baseline and similarly complete research measures at the end of the waiting period (8-weeks). In addition, a nested study examining the mediators and moderators for change and maintenance of change is included. Specific and general mechanisms of change will be explored to include positive beliefs about repetitive negative thinking, therapeutic skills usage and therapist behaviours. General mediators including the therapeutic alliance and participant's expectancy / credibility and will be examined. The study protocol, information on the study, informed consent will be submitted for approval by the NHS England Research Ethics Committee and Health Research Authority approval for the study will be sought. The study aims to evaluate the effectiveness and cost effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT. Individuals who contact Berkshire Healthcare NHS Foundation Trust to access IAPT psychological services will be eligible to participate. Recruitment will begin in May 2017 and will continue for 6 months until the numbers are reached or exceeded. Using G-Power to calculate our sample size and based on a moderate between group effect size of d=0.5 with a power of 80% and a 2:1 randomisation procedure into immediate treatment for depression and/or anxiety and a corresponding waiting list control group returned a total sample of 288. Adding a 25% uplift to ameliorate against attrition gave a total sample size of 360. Therefore for depression a total sample of 120 in the treatment group and a corresponding 60 in the control group and the same ratio for anxiety disorders. The 2:1 randomisation procedure was implemented to reduce the concern of having many people waiting for treatment after presenting to the IAPT service. PWP clinicians who are involved in the study trial as supporters to participants will be invited to take part in the research, to complete post-review alliance measures online, complete post review therapist behaviours checklist and volunteer for a semi-structured interview to collect qualitative data on therapeutic alliance and therapist behaviours.

Official Title
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Digital IAPT: The Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in the Improving Access to Psychological Therapies Programme

Conditions
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Depression, Anxiety Disorders, Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Phobic Disorders, Panic Disorder, Health Anxiety

Intervention / Treatment
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* Behavioral: SilverCloud Internet-delivered Cognitive Behavioural Therapy
* Other: Waiting List


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A score of ≥ 9 on PHQ-9 and/ or a score of ≥ 8 on GAD-7 18 years of age Suitable for an internet-delivered intervention (iCBT) Exclusion Criteria: Suicidal intent/ideation Psychotic illness Currently in psychological treatment for depression and/or anxiety Alcohol or drug misuse Previous diagnosis of an organic mental health disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCBT for Depression and Anxiety<br>SilverCloud Internet-Delivered Cognitive Behavioural Therapy | Behavioral: SilverCloud Internet-delivered Cognitive Behavioural Therapy<br>* SilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions for all of the anxiety disorders (panic disorder, social anxiety, phobias, GAD, health anxiety, OCD), depression and also comorbid depression and anxiety. The programs for the treatment of depression and anxiety employ several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social. Research on the SilverCloud interventions has yielded significant clinical outcomes (Richards et al., 2015).<br>|
| Active Comparator: Waiting List<br>Waiting list control | Other: Waiting List<br>* 8 week waiting list period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression symptoms | Measured by the 9 item Patient Health Questionnaire (PHQ-9) | Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Change in Anxiety symptoms | Measured by the 7 item Generalised Anxiety Disorder inventory (GAD-7) | Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work and Social Adjustment | Measured using the Work and Social Adjustment scale (WSAS) | Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Social Anxiety | Measured using the Social Phobia Inventory (SPIN) | Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Health Anxiety | Measured using the Short Health Anxiety Inventory (SHAI) | Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Panic | Measured using the Panic Disorder Severity Scale (PDSS) | Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Generalised Anxiety Symptoms | Measured using the Penn State Worry Questionnaire (PSWQ) | Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Quality of life | Measured using the EQ5D5L | baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Quality of life for users of mental health services | Measured using the Re-QOL | baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Client service usage | Measured using the Client Services Receipt Inventory (CSRI) | baseline, 8 weeks, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Emotion Regulation | Measured using the Emotion Regulation Questionnaire (ERQ) | Baseline and 8 weeks | 
| Rumination | Measured using the Positive Beliefs about Depressive Rumination scale (PBRS-A) | Baseline and 8 weeks | 
| Therapeutic Expectancy | Measured using the Expectancy/Credibility scale (TEQ) | Baseline, 4 weeks and 8 weeks. | 
| CBT Skills Usage | Measured using the Frequency of Actions and Thoughts scale (FATS) | 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up | 
| Therapist Behaviours | Measured using the Therapist Behaviours Checklist (TBCL) | Continuous during treatment after each session for 8 weeks | 
| Therapeutic Alliance for patients | Measured using the Scale to Assess Therapeutic Relationships - Patient Version (STAR-P) | Continuous during treatment after each session for 8 weeks | 
| Therapeutic Alliance for clinicians | Measured using the Scale to Assess Therapeutic Relationships - Clinician version (STAR-C) | Continuous during treatment after each session for 8 weeks | 
| Therapeutic Alliance for clinicians | Semi-structured interview will be employed to assess qualitatively clinicians experience of the therapeutic relationship online. | During the patient recruitment period. | 
| M.I.N.I. International Neuropsychiatric Interview | Used to determine a diagnosis of depression and/or anxiety (MINI) | Baseline and 3-month follow-up | 
| Patient Experience/Satisfaction | Measured using the Patient Experience Questionnaire (PEQ) | Post treatment (up to 8 weeks). |