Understanding the Person, Exploring Change Across Psychotherapies

NCT ID: NCT04106713

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2023-09-30

Brief Summary

Identifying predictors and understanding mechanisms of change will inform referral to psychotherapy, triage and right-siting by helping clinicians to understand how their patients are likely to benefit from clinical interventions. This study will be the first of its kind conducted in an Asian hospital setting to identify the predictors of response to individual, group and internet-delivered CBT for the treatment of depressed and anxious patients in the Institute of Mental Health (IMH), Singapore. With increasing challenges with hospital workload, there is an increasing emphasis on group and online interventions. Understanding of the factors that may predict outcome from these therapies can improve right-siting by identifying who will get better without therapy or who may not benefit from a given form of therapy and guide personalisation of care. An important biological predictor of outcome is likely to be genetic risk as it has been demonstrated that patients with greater melancholia and a family history may not be sufficiently treated with brief courses of therapy. Identifying psychological factors underlying psychological distress and determining the extent to which these factors are addressed by these interventions will help to improve and individualise existing psychotherapy and motivate new psychotherapeutic interventions.

Detailed Description

All IMH outpatients who have been referred for psychotherapy will be invited to take part in this research. Participants will be recruited from triage, outpatient clinics, emergency services and referrals from therapists. In specific, participants under the iCBT and group CBT (for e.g. PsychUp) treatment arms will be recruited from the Psychology Department from triage and those under individual therapy will be recruited from the Psychotherapy Department.

After indicating interest to participate in the study, potential patients will be contacted to explain the purpose of the study and its procedures, obtain informed consent to take part in the study as well as brief them on how to log on and access and complete questionnaires.

Participants will be placed into the study arms (i.e. iCBT, group CBT or individual therapy) based on the intervention program each has been allocated to. Some participants will also form a Delayed Waitlist group. Other participants will form the Treatment as Usual (TAU) group. Participants in the Waitlist group will be recruited from those referred for psychotherapy and who are not assigned to either group or iCBT and not planned for psychotherapy at IMH for 8 weeks or more from the point of consent. Participants in the Treatment as Usual (TAU) group are individuals who are not assigned to psychotherapy at IMH. They will be recruited from outpatient services and emergency services at IMH.

The Waitlist and Treatment as Usual Groups will serve as the control groups.

For all groups, psychiatric and medical history, pharmacological and other non-psychological interventions will first be obtained at baseline in order to control for other treatment effects. Such medical records would be accessed via c-Doc; data will be obtained from information management and the IMH diagnostics. SAP data at IMH, including demographic data, postal code, diagnosis, race, clinician names (but not limited to), will be collected for this study.

For the psychotherapy arms (iCBT, group CBT, and individual therapy), assessments will be conducted from baseline across the course of participants' psychotherapy interventions as well as into follow-up. A baseline battery will be completed before the start of therapy. The baseline battery includes vulnerability measures, around half of which will serve as the independent variables and the other half will be used to assess outcome, during their first visit (i.e. triage). This series of baseline measures will take approximately 50 min to complete. For iCBT, group CBT and individual therapy, there will be study visits after each session of therapy, whereby participants will be asked to complete a series of additional measures. The series of weekly measures will take approximately 15 min to complete. Any measures that the therapists use regularly when sending out the measures will be left out and the therapist can request for the outcomes to be either emailed or uploaded on C-doc for their reference. After the last session, participants would complete a post-intervention battery besides the post-session measures. The series of post-intervention measures, to be completed above the weekly measures on the last therapy session, will take approximately 45 min to complete.

Mechanisms of change: Process-outcome in Individual Therapy In 30 clients undergoing frequent individual therapy (ideally once a fortnight or more), in addition to the quantitative measurement of outcome, consent will be taken to allow audio with or without video recording of their sessions. Their therapist will also provide consent for recording of sessions. Sessions will be recorded by their therapist. Sessions will be subsequently transcribed and coded with scales to assess alliance-building, interventions, and emotional work. Initial coding will use the comparative psychotherapy process scale, the facilitative interpersonal scale, and the emotional arousal scale according to a coding manual by trained raters.

For every 3 months for two years (if consented to), participants may complete the follow-up measures. For iCBT and group CBT, therapy sessions would take place weekly for 8 weeks. For individual therapy, therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.

Buccal swabs will be obtained from consenting participants at baseline and post-therapy to conduct genome-wide association scanning to construct polygenic risk scores for prediction of response to therapy and assess epigenetics as a vulnerability factor pre-post therapy.

Timeline and list of measures for waitlist and group TAU (refer to appendix): For waitlist/TAU, assessments will be completed at Week 0, Week 4, Week 8 and for follow-ups (see attached Gantt chart).

Participants in the waitlist/ TAU groups will not undergo buccal swabs.

Participants in the waitlist arm would be individuals who have been referred for psychotherapy but would not be undergoing therapy for at least 8 weeks from the point of recruitment into this study, and hence will serve as the control group. It is highly likely that a considerable proportion of participants in the waitlist group would eventually undergo therapy within the period of study follow up (up to 2 years). In this case, the data collected from such participants from before they begin therapy would first be retained, and such participants would also subsequently be recruited into the psychotherapy arm of the study, where they would complete all procedures of the study.

In the event that TAU participants are referred for psychotherapy over the duration of the study, the data collected from such participants from before they begin therapy would first be retained, and also subsequently recruit them into the psychotherapy arm of the study.

Baseline and post-intervention measures will be completed online.

For post-session/ follow-up measures online, Pragmatic Tracker, an official online platform used by the Institute of Mental Health for administering scales to therapy patients, will be utilized. Any measures that the therapists use regularly will be left out when sending out the measures and the therapist can request for the outcomes to be either emailed or uploaded on Cdoc for their reference.

For all groups, psychiatric and medical history, pharmacological and other non-psychological interventions will first be verified during follow-up in order to control for other treatment effects. Such medical records would be accessed via c-Doc. Data will be obtained from information management and the IMH diagnostics.

Like the therapists, the triage psychologists will also be given a background information form during triage review that probes their experience as a triage officer and general client expectations (Therapist/Triage Officer Background Information Form). It is hypothesized that such evaluations by the triage psychologists may affect treatment outcome. For TAU and Waitlist, the patient's clinician will assist in completing the GAF.

Incidental findings are not anticipated for any patients from this study. Only DNA will be extracted after the collection of the buccal swabs, which would not reveal any incidental findings of potential health and reproductive importance. However, the possibility that a genetic test will be developed in the future that can use the collected data and predict the development of a disease in later life with certainty, and which becomes apparent from the study's analyses, cannot be excluded. This is considered to be unlikely as the study only looks at common genetic variants in this study. The study informs participants of the potential to uncover incidental findings in future research in the ICF, and provide for re-identification of participants in such cases.

There will not be any incidental findings for the therapists as there will not be any biological/clinical tests that the therapists themselves will complete that may reveal potential health or reproductive importance.

Hard copies or soft copies of scales may be administered at all time points or may be administered over the phone, depending on the preference on the participants and licensing permissions. Scales will be made available for completion online wherever possible, except for scales such the Anxiety Sensitivity Index (only allowed to be administered on paper) and EQ5D-L5 (on phone/ paper). Online modes of administration include Pragmatic Tracker, REDCAP and QuestionPro. QuestionPro and REDCAP are research platforms also used by IMH/SICS and have the function of scheduling surveys at several time points.

Conditions

Depression; Anxiety Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individual Therapy

The individual therapy program will differ in orientation according to therapist and session notes will be coded according to the Comparative Psychotherapy Process Scale. Therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.

Group Type: EXPERIMENTAL

Individual Psychotherapy

Intervention Type: BEHAVIORAL

The individual therapy program will differ in orientation according to therapist and session notes will be coded according to the Comparative Psychotherapy Process Scale. Therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.

Internet-delivered Cognitive Behavioural Therapy (iCBT)

The iCBT program (clinician follow-up with the therapist and 4 online modules) will be administered for 8 weeks. The four modules: "1) psychoeducation about emotions, including a functional nature of emotions; 2) alteration of antecedent cognitive misappraisals; 3) prevention of emotional avoidance; and 4) modification of emotion-driven \[behaviours\] (EDBs)", are adapted from The Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. UP is a CBT consisting of four overarching themes- "increasing emotional awareness, facilitating flexibility in appraisals, identifying and preventing \[behavioural\] and emotional awareness, and situational and interoceptive exposure to emotion cues".

Group Type: EXPERIMENTAL

Internet-delivered Cognitive Behavioural Therapy (iCBT)

Intervention Type: BEHAVIORAL

The iCBT program (clinician follow-up with the therapist and 4 online modules) will be administered for 8 weeks. The four modules: "1) psychoeducation about emotions, including a functional nature of emotions; 2) alteration of antecedent cognitive misappraisals; 3) prevention of emotional avoidance; and 4) modification of emotion-driven \[behaviours\] (EDBs)", are adapted from The Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. UP is a CBT consisting of four overarching themes- "increasing emotional awareness, facilitating flexibility in appraisals, identifying and preventing \[behavioural\] and emotional awareness, and situational and interoceptive exposure to emotion cues".

Group CBT

The group CBT program (for e.g. PsychUp) will be conducted over 8 weeks, with weekly 2-hour sessions. Each group consists of 4-8 patients and are facilitated by two practicing clinical psychologists and one clinical psychologist in training. Sessions are structured such that each session, except the first, begins with a brief review of previous session material and a collaborative review of homework. This is followed by introduction of new material and completion of any in-session exercises, with sessions concluding with homework assignment. Specific treatment content is similarly adapted from UP. Session 1 begins by covering psychoeducation on the CBT model of pathological depression and anxiety and the role of avoidance in maintenance of symptoms. Sessions 2 to 7 covers goal-setting, cognitive reappraisal and development of adaptive emotional coping strategies through situational emotion-focused exposures. Session 8 ends with a discussion on relapse prevention.

Group Type: EXPERIMENTAL

Group Cognitive Behavioural Therapy (group CBT)

Intervention Type: BEHAVIORAL

The group CBT program (for e.g. PsychUp) will be conducted over 8 weeks, with weekly 2-hour sessions. Each group consists of 4-8 patients and are facilitated by two practicing clinical psychologists and one clinical psychologist in training. Sessions are structured such that each session, except the first, begins with a brief review of previous session material and a collaborative review of homework. This is followed by introduction of new material and completion of any in-session exercises, with sessions concluding with homework assignment. Specific treatment content is similarly adapted from UP. Session 1 begins by covering psychoeducation on the CBT model of pathological depression and anxiety and the role of avoidance in maintenance of symptoms. Sessions 2 to 7 covers goal-setting, cognitive reappraisal and development of adaptive emotional coping strategies through situational emotion-focused exposures. Session 8 ends with a discussion on relapse prevention.

Delayed Waitlist

Participants in the Waitlist group will be recruited from those referred for psychotherapy and who are not assigned to either group or iCBT and not planned for psychotherapy at IMH for 8 weeks or more from the point of consent.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment as Usual (TAU)

Participants in the Treatment as Usual (TAU) group are individuals who are not assigned to psychotherapy at IMH. They will be recruited from outpatient services and emergency services at IMH.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individual Psychotherapy

The individual therapy program will differ in orientation according to therapist and session notes will be coded according to the Comparative Psychotherapy Process Scale. Therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.

Intervention Type: BEHAVIORAL

Internet-delivered Cognitive Behavioural Therapy (iCBT)

The iCBT program (clinician follow-up with the therapist and 4 online modules) will be administered for 8 weeks. The four modules: "1) psychoeducation about emotions, including a functional nature of emotions; 2) alteration of antecedent cognitive misappraisals; 3) prevention of emotional avoidance; and 4) modification of emotion-driven \[behaviours\] (EDBs)", are adapted from The Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. UP is a CBT consisting of four overarching themes- "increasing emotional awareness, facilitating flexibility in appraisals, identifying and preventing \[behavioural\] and emotional awareness, and situational and interoceptive exposure to emotion cues".

Intervention Type: BEHAVIORAL

Group Cognitive Behavioural Therapy (group CBT)

The group CBT program (for e.g. PsychUp) will be conducted over 8 weeks, with weekly 2-hour sessions. Each group consists of 4-8 patients and are facilitated by two practicing clinical psychologists and one clinical psychologist in training. Sessions are structured such that each session, except the first, begins with a brief review of previous session material and a collaborative review of homework. This is followed by introduction of new material and completion of any in-session exercises, with sessions concluding with homework assignment. Specific treatment content is similarly adapted from UP. Session 1 begins by covering psychoeducation on the CBT model of pathological depression and anxiety and the role of avoidance in maintenance of symptoms. Sessions 2 to 7 covers goal-setting, cognitive reappraisal and development of adaptive emotional coping strategies through situational emotion-focused exposures. Session 8 ends with a discussion on relapse prevention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. For patients:

1. 18-99 years old;

2. have current or past symptoms of anxiety and/or depression;

3. able to communicate and read in English;

4. able to provide informed consent.

5. Waitlist arm:

• Referred for psychotherapy but given a waiting time of 8 weeks or more to the first visit or not assigned to therapy at IMH.

6. Treatment as usual:

• Not assigned to any psychotherapeutic interventions.

7. iCBT: - Referred for iCBT;

• Identified as a 'P2' patient/appropriate for iCBT by triage.

8. Group therapy:

• Referred for group therapy;

• Identified as a 'P2' patient/appropriate for group therapy by triage.

9. Individual psychotherapy:

• Referred for individual therapy;
• Patient and therapist committed to frequent therapy (ideally fortnightly).

2. For therapists:

1. Therapists who will see OR have been assigned to clients in the waitlist arm, iCBT, group therapy (e.g. PsychUp), and individual psychotherapy group.

Exclusion Criteria

1. For patients:

1. current active suicidal intention or plan;

2. cognitively-impaired/are unable to consent/lack capacity to consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Mental Health, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey CY Tan

Role: PRINCIPAL_INVESTIGATOR

Institute of Mental Health, Singapore

Locations

Institute of Mental Health, Singapore

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Geoffrey CY Tan

Role: CONTACT

geoffrey_tan@imh.com.sg

+65 63891923

Facility Contacts

Geoffrey CY Tan

Role: primary

geoffrey_tan@imh.com.sg

+65 63891923

Other Identifiers

2018/01184

Identifier Type: -

Identifier Source: org_study_id