The Internet Therapy for Depression Trial (INTEREST)

Memorial University of Newfoundland

Status: Completed

Conditions: Major Depressive Disorder; Chronic Pain

Treatments: Other: Attention Control (AC); Behavioral: internet delivered cognitive behavioural therapy (iCBT); Behavioral: online delivered acceptance and commitment therapy (iACT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04009135

HREB2018.275

Details and patient eligibility

About

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.

Full 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."

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 3 patient groups, including a placebo group

internet delivered cognitive behavioural therapy (iCBT)

Experimental group

Description:

The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.

Treatment:

Behavioral: internet delivered cognitive behavioural therapy (iCBT)

online delivered acceptance and commitment therapy (iACT)

Experimental group

Description:

The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind \& acceptance; 5) mindfulness; 6) values; and 7) taking action. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.

Treatment:

Behavioral: online delivered acceptance and commitment therapy (iACT)

Attention Control (AC)

Placebo Comparator group

Description:

Patients in the control condition will be given access online psychoeducation about depression and chronic pain. They will be provided weekly phone calls to query symptoms and well-being.

Treatment:

Other: Attention Control (AC)