Clinical trial NCT04009135: The Internet Therapy for Depression Trial
Official title: The Internet Therapy for Depression Trial (INTEREST): A Doubly-randomized, Patient-preference, Controlled Feasibility Trial Comparing iACT, iCBT, and Attention Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Major Depressive Disorder
Keywords: Chronic non-cancer pain
Major depression
Internet therapies
Cognitive behaviour therapy
Acceptance and commitment therapy
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Doubly-randomized, patient-preference trial with two active study interventions and one control.
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) interventions tailored towards the treatment of depression and chronic pain using a doubly-randomized, attention-controlled, non-blinded, patient-preference design.

Detailed description: The primary objective is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) on depressed mood among individuals with chronic pain relative to attention control (AC). The secondary objectives are to evaluate the efficacy of iCBT and iACT on clinically relevant outcomes endorsed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Adults with chronic non-cancer pain and major depression will be randomized to receive iACT, iCBT, or AC. The interventions comprise 7 weekly online modules available through Therapist Assisted Online (TAO). Patients will be contacted weekly by a member of the study team who will be acting as their personalized "online therapy coach."

Eligibility criteria: Inclusion Criteria:

* Fluent in English
* 18 years of age or older
* have a primary diagnosis of chronic non-cancer pain.
* meet DSM-5 criteria for a diagnosis of major depressive disorder
* have access to the internet, email, and telephone
* can commit to the demands and timelines of the trial.
* Given high comorbidity in this population, patients with sleep disturbance or comorbid anxiety will also be eligible to participate.

Exclusion Criteria:

* diagnosis of cognitive impairment (e.g., dementia)
* active suicidal ideation
* severe psychopathology (e.g., schizophrenia)
* unable to sign a safety contract for the duration of the trial
* concurrent participation in psychotherapy.

Primary outcomes:
measure: Screening and Consent Rates
timeFrame: Through study completion, up to 2-years
measure: Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Change from baseline to end of treatment (i.e., week 8).
measure: Adherence to intervention measured as frequency of visits to online modules.
timeFrame: End of treatment (i.e., week 8)
measure: Perceived acceptability of treatment measured using qualitative interviews
timeFrame: Completion of the intervention (i.e., week 8)
Secondary outcomes:
measure: Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF)
timeFrame: Baseline, 4-weeks, and post-intervention (i.e., week 8)
measure: Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21).
timeFrame: Baseline and through study completion, an average of 8-weeks.
measure: Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF)
timeFrame: Baseline and through study completion, an average of 8-weeks.
measure: Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI).
timeFrame: Baseline and through study completion, an average of 8-weeks.
measure: Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire.
timeFrame: Baseline and through study completion, an average of 8-weeks.
measure: Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire.
timeFrame: Baseline and through study completion, an average of 8-weeks.
Other outcomes:
Locations:
city: Saint John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
Study officials:
References:
citation: Bell LV, Cornish P, Flusk D, Garland SN, Rash JA. The INternet ThERapy for deprESsion Trial (INTEREST): protocol for a patient-preference, randomised controlled feasibility trial comparing iACT, iCBT and attention control among individuals with comorbid chronic pain and depression. BMJ Open. 2020 Feb 28;10(2):e033350. doi: 10.1136/bmjopen-2019-033350.