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

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.

• SilverCloud Internet-delivered Cognitive Behavioural Therapy (Behavioral): 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).
• Waiting List (Other): 8 week waiting list period.

Primary outcomes

• Change in Depression symptoms [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]: Measured by the 9 item Patient Health Questionnaire (PHQ-9)
• Change in Anxiety symptoms [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]: Measured by the 7 item Generalised Anxiety Disorder inventory (GAD-7)

Secondary outcomes

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

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. A score of ≥ 9 on PHQ-9 and/ or a score of ≥ 8 on GAD-7
2. 18 years of age
3. Suitable for an internet-delivered intervention (iCBT)

Exclusion Criteria:

1. Suicidal intent/ideation
2. Psychotic illness
3. Currently in psychological treatment for depression and/or anxiety
4. Alcohol or drug misuse
5. Previous diagnosis of an organic mental health disorder

• Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21. PMID 26523885
• Results publication: Richards D, Duffy D, Blackburn B, Earley C, Enrique A, Palacios J, Franklin M, Clarke G, Sollesse S, Connell S, Timulak L. Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial. BMC Psychiatry. 2018 Mar 2;18(1):59. doi: 10.1186/s12888-018-1639-5. PMID 29499675

• Derek Richards, PhD, Study director, SilverCloud Health
• Sarah Sollesse, MSc, Principal investigator, Berkshire Healthcare NHS Foundation Trust