The Internet Therapy for Depression Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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."

Conditions

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Chronic Pain Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Doubly-randomized, patient-preference trial with two active study interventions and one control.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

A research assistant not affiliated with the study will use Research Randomizer (http://www.randomizer.org/) to generate lists of randomly sequenced numbers to allocate patients to trial arm. To reduce biases and expectation effects, the research assistant will not be aware of what condition the patients are allocated when conducting baseline assessments and a research assistant not affiliated with the research will complete outcome assessments without being aware of allocation. Interventionists will be aware of which group patients are allocated to, as will patients.

Study Groups

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internet delivered cognitive behavioural therapy (iCBT)

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.

Group Type EXPERIMENTAL

internet delivered cognitive behavioural therapy (iCBT)

Intervention Type BEHAVIORAL

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.

online delivered acceptance and commitment therapy (iACT)

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.

Group Type EXPERIMENTAL

online delivered acceptance and commitment therapy (iACT)

Intervention Type BEHAVIORAL

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.

Attention Control (AC)

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.

Group Type PLACEBO_COMPARATOR

Attention Control (AC)

Intervention Type OTHER

1-module of psychoeducation about chronic pain and major depression. Weekly contact to complete measures of symptomatology and well-being.

Interventions

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internet delivered cognitive behavioural therapy (iCBT)

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.

Intervention Type BEHAVIORAL

online delivered acceptance and commitment therapy (iACT)

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.

Intervention Type BEHAVIORAL

Attention Control (AC)

1-module of psychoeducation about chronic pain and major depression. Weekly contact to complete measures of symptomatology and well-being.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No